impurity reference ep - lgc ltd€¦ · (anagrelide impurity b) 1159977-03-3 a604740...

72
IMPURITY REFERENCE EP Impurities, USP Impurities, BP Impurities, Labeled Impurities & Pharmaceutical Impurities lgcstandards.com [email protected]

Upload: others

Post on 17-Aug-2020

3 views

Category:

Documents


0 download

TRANSCRIPT

Page 2: IMPURITY REFERENCE EP - LGC Ltd€¦ · (Anagrelide Impurity B) 1159977-03-3 A604740 2-Amino-5,6-dichloro-3(4H)-quinazoline Acetic Acid Hydrobromide (Anagrelide Impurity B) 1194434-39-3

2 20 Martin Ross Avenue North York, ON Canada, M3J 2K8

www.trc-canada.com [email protected] +1-416-665-9696

Chemical Name CAS Number Catalog Number

Abacavir 136470-78-5 A104990

Abacavir Sulfate 188062-50-2 A105000

Abacavir Carboxylate 384380-52-3 A105005

ent-Abacavir 136470-79-6 A105015

Abacavir 5’-Phosphate 136470-77-4 A105020

Abacavir 5’-4-Chloro-6-methylpyrimidine-2,5-diamine 1443421-69-9 A105035

Acarbose D-Fructose Impurity 1013621-79-8 A123515

Acebutolol Dimer Impurity 1330165-98-4 A123890

Aceclofenac Benzyl Ester 100499-89-6 A130410

Aceclofenac Ethyl Ester 139272-67-6 A130415

Aceclofenac Methyl Ester 139272-66-5 A130420

bis(2-Acetamido-1,3,4-thiadiazol-5-yl) Disulfide 99055-56-8 A132750

4-Acetamidobenzenesulfonic Acid 121-62-0 A141875

2-Acetamidophenol 614-80-2 A158490

N-(5-Acetamido-1,3,4-thiadiazole-2-yl) Acetazolamide A160000

3-Acetamidophthalic Acid 15371-06-9 A161140

Acetaminophen Acetate (Acetaminophen Impurity) 2623-33-8 A161215

N-[5-(Acetylamino)-2-hydroxyphenyl]-N-(4-hydroxyphenyl)acetamide 98966-17-7 A161245

Acetic Aceclofenac 1215709-75-3 A161550

Acetoacetamide 5977-14-0 A161805

9-[4-Acetoxy-3-(acetoxymethyl)butyl]-2-amino-6-chloropurine 97845-60-8 A164140

1-[(2β,3α,5α,16β,17β)-3-(Acetyloxy)-17-hydroxy-2-(1-piperidinyl)androstan-16-yl]-1-methylpiperidinium Bromide

50587-95-6 A164495

(2β,3α,5α,16β,17β)-17-Acetoxy-3-hydroxy-2-(4-morpholinyl)-16-(1-pyrrolidinyl)androstane

119302-24-8 A165650

21-Acetoxy-11β-hydroxy-16α,17α-propylmethylenedioxpregna-1,4-diene-3,20-dione

51333-05-2 A165740

21-Acetoxy-11β-hydroxypregna-1,4,16-triene-3,20-dione 3044-42-6 A165755

N-Acetyl-N-[2-(7-methoxy-1-naphthalenyl)ethyl]acetamide 1379005-34-1 A167620

20α-Acetoxy-4-pregnen-3-one 5035-09-06 A167690

1-Acetyl-2-imidazolidinone 5391-39-9 A167955

Acyclovir N,O-Diacetate 75128-73-3 A167995

N2-Acetyl Acyclovir 110104-37-5 A168015

N-Acetyl Adamantamine 880-52-4 A168050

5-(Acetylamino)-1,3,4-thiadiazole-2-sulfonic Acid Potassium Salt A168090

2-Acetamido-5-mercapto-1,3,4-thiadiazole 32873-56-6 A168105

4-Acetylamino-2-chlorophenol 3964-54-3 A168175

4-Acetylamino-3-hydroxybenzoic Acid Ethyl Ester 1346604-18-9 A168250

3'-N-[[4-(Acetylamino)phenyl]sulfonyl]-3'-N-demethyl Azithromycin 612069-30-4 A168295

Page 3: IMPURITY REFERENCE EP - LGC Ltd€¦ · (Anagrelide Impurity B) 1159977-03-3 A604740 2-Amino-5,6-dichloro-3(4H)-quinazoline Acetic Acid Hydrobromide (Anagrelide Impurity B) 1194434-39-3

3 20 Martin Ross Avenue North York, ON Canada, M3J 2K8

www.trc-canada.com [email protected] +1-416-665-9696

Chemical Name CAS Number Catalog Number

N-Acetyl-4-aminosalicylic Acid 50-86-2 A168325

Acetanilide (Acetylaniline) 103-84-4 A168330

21-O-Acetyl Dexamethasone 1177-87-3 A168480

N-Acetyl Cefpodoxime Proxetil 947692-15-1 A168610

3-Acetylbenzophenone 66067-44-5 A170975

3-Acetylaminophthalic Anhydride 6296-53-3 A170980

4-Acetoxy-2',4'-difluorobiphenyl 59089-67-7 A171095

Acetylclonidine 54707-71-0 A172120

3-Acetyl-17-deacetyl Rocuronium Bromide 1190105-63-5 A172180

N-Acetyl-2,6-dichlorodiphenylamine 84803-53-2 A173570

5-Acetyl-10,11-dihydro-5H-dibenzo[b,f]azepine 13080-75-6 A173695

3’-Acetyl-4’-(2,3-epoxypropoxy)butyranilide 28197-66-2 A173780

3-O-Acetyl Ezetimibe 1044664-24-5 A173795

Acetylfentanyl 3258-84-2 A175000

N-(3-Acetyl-4-hydroxyphenyl)butanamide 40188-45-2 A178975

(±)-N-[3-Acetyl-4-[2-hydroxy-3-[(1-methylethyl)amino]propoxy]phenyl]propanamide Monohydrochloride

57898-79-0 A178980

1-Acetylimidazolidinethione 5391-52-6 A179185

O-Acetyl Losartan 1006062-27-6 A185300

3-(Acetylmethylamino)-1-propanesulfonic Acid Calcium Salt 233591-26-9 A186550

N-Acetyl Metoclopramide 5608-13-9 A186860

N2-Acetyl Neamine A187013

7-Acetyl Paclitaxel 92950-39-5 A187375

N-Acetylpiperazine-N’-(4-phenol) Ketoconazole 1346598-39-7 A187500

3-Acetylpyridine 350-03-8 A187600

17-Acetyloxy-pregna-1,4-diene-3,20-dione (~90%) 2668-74-8 A187710

3-Acetyl Rocuronium Bromide 122483-73-2 A187730

Acetylsalicylic Anhydride 1466-82-6 A187785

Acetylsalicylsalicylic Acid 530-75-6 A187788

4'-Acetyl Simvastatin 145576-25-6 A187795

N-Acetyl Sulfamethoxazole 21312-10-7 A187885

13,14-Anhydro-10-desacetyl Baccatin 1217248-58-2 A187928

(4-Acetyl-L-Serine)Leuprorelin Trifluoroacetic Acid Salt A187985

(3S,4aR,5S,6S,11R,12R,12aR)-5-(Acetyloxy)-1,2,3,4,4a,5,6,7,8,11,12,12a-dodecahydro-6,11,12-trihydroxy-9,12a,13,13-tetramethyl-4-methylene-8-oxo-6,10-methanobenzocyclodecen-3-yl β-(Dimethylamino)-benzenepropanoate

959572-72-6 A188100

Paclitaxel Impurity O 219783-77-4 A188120

(11β,16α)-21-(Acetyloxy)-11,16,17-trihydroxypregna-1,4,14-triene-3,20-dione

131918-72-4 A188360

Page 4: IMPURITY REFERENCE EP - LGC Ltd€¦ · (Anagrelide Impurity B) 1159977-03-3 A604740 2-Amino-5,6-dichloro-3(4H)-quinazoline Acetic Acid Hydrobromide (Anagrelide Impurity B) 1194434-39-3

4 20 Martin Ross Avenue North York, ON Canada, M3J 2K8

www.trc-canada.com [email protected] +1-416-665-9696

Chemical Name CAS Number Catalog Number

2-Acetylthioethanesulfonic Acid 69536-71-6 A188740

7α-Acetylthio-17α-ethoxymethyl Testosterone A188745

3-Acetylthio-2-methylpropionic Acid 33325-40-5 A188775

N-Acetyl Tizanidine 173532-15-5 A188870

N-Acetyl L-Thyroxine 26041-51-0 A188890

1-O-Acetyl-2,3,5-tri-O-benzoyl-β-D-ribofuranose 6974-32-9 A189330

5-Acetyl-3-chloroiminodibenzyl 25961-11-9 A189530

Acotiamide Methyl Ether 185103-80-4 A190265

Acyclovir 59277-89-3 A192400

Acyclovir Acetate 102728-64-3 A192410

Acyclovir N-Methyl-L-valinate Hydrochloride 1346617-39-7 A192430

Acyclovir Formacetal Dimer A192435

Acyclovir N-Methylene Dimer 1797131-64-6 A192450

o-Adamantylanisole 43109-77-9 A208250

Adapalene Methyl Ester 106685-41-0 A225010

7-ADCA Pivalamide 146794-70-9 A235000

Agomelatine Dimer Acetamide 1385018-58-5 A430020

Agomelatine Dimer Urea 185421-27-6 A430025

Albendazole Sulfone 75184-71-3 A511615

Albendazole Sulfoxide 54029-12-8 A511620

Albuterol Aldehyde Hemisulfate 156339-88-7 A514495

Albuterol Methyl Ether Hydrochloride Salt A514510

Albuterol Dimer Ether, 75% 147663-30-7 A514520

(3R,4R,5S)-4-(Acetylamino)-5-amino-3-(1-methylethoxy)-1-Cyclohexene-1-carboxylic Acid Ethyl Ester

1052063-36-1 A549303

Allylamine 107-11-9 A549550

6-Allyl-8β-carboxyergoline 81409-74-7 A549620

Almotriptan N-Oxide Hydrochloride Salt 1391054-49-1 A575210

Aloe-emodin 481-72-1 A575400

rac-cis-Ambroxol 107814-37-9 A575905

Ambroxol Cyclic Impurity Hydrochloride 15942-08-2 A575910

6-Aminoadamantane-1,3-diol 918830-94-1 A580150

Amino Albendazole 80983-36-4 A580945

Amino Albendazole Sulfone 80983-34-2 A580950

4-Aminoanastrozolium Bromide 906813-01-2 A583720

N-(4-Aminobenzenesulfonyl) Sulfamethoxazole 135529-16-7 A591480

3-Aminobenzoic Acid 1999-05-08 A591490

2-Amino-5(6)-benzoylbenzimidazole 52329-60-9 A593760

Page 5: IMPURITY REFERENCE EP - LGC Ltd€¦ · (Anagrelide Impurity B) 1159977-03-3 A604740 2-Amino-5,6-dichloro-3(4H)-quinazoline Acetic Acid Hydrobromide (Anagrelide Impurity B) 1194434-39-3

5 20 Martin Ross Avenue North York, ON Canada, M3J 2K8

www.trc-canada.com [email protected] +1-416-665-9696

Chemical Name CAS Number Catalog Number

N-(4-Aminobenzoyl)-L-glutamic Acid 4271-30-1 A593770

N-(4-Aminobenzoyl)-β-alanine 7377-08-04 A593795

N-[1-(Aminocarbonyl)-2,2-dimethylpropyl]-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide

1863065-92-2 A593935

2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]ethylester N-Methyl-L-Valine

1346747-65-6 A597115

(S)-4-(4-Aminobenzyl)-2-(1H)-oxazolidinone 152305-23-2 A599500

5-Amino-N,N'-bis[2-hydroxy-1-(hydroxymethyl)ethyl]-2,4,6-triiodo-1,3-benzenedicarboxamide

60166-98-5 A601550

4-Amino-1-[3,5-bis-O-(4-chlorobenzoyl)-2-deoxy-α-D-erythro-pentofuranosyl]-1,3,5-triazin-2(1H)-one

1140891-02-6 A601700

4-Amino-1-[3,5-bis-O-(4-chlorobenzoyl)-2-deoxy-β-D-erythro-pentofuranosyl]-1,3,5-triazin-2(1H)-one

1034301-08-0 A601705

2-(2-Amino-5-bromobenzoyl)pyridine 1563-56-0 A601785

6-Amino-5-bromoquinoxaline 50358-63-9 A601885

2-Amino-5-bromo-N-cyclohexyl-N-methylbenzylamine Dihydrochloride 10076-98-9 A601925

(S)-2-Aminobutyramide Hydrochloride 7682-20-4 A602890

α-[(Aminocarbonyl)thio]-4-[2-(5-ethyl-2-pyridinyl)ethoxy]benzenepropanoic Acid Ethyl Ester (Pioglitazone Impurity)

868754-41-0 A603065

3-Amino-4-carbamoylpyrazole Hemisulfate 27511-79-1 A603076

1-[[(6R,7R)-7-Amino-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-en-3-yl]methyl]-1-methylpyrrolidinium Chloride

103121-85-3 A603160

7-Amino-3-chloro-3-cephem-4-carboxylic Acid 53994-69-7 A603305

4-Amino-5-chloro-2-methoxybenzoic Acid 7206-70-4 A603320

(1S,4R)-4-(2-Amino-6-chloro-9H-purin-9-yl)-2-cyclopentene-1-carboxylate 1246819-78-2 A603360

4-Amino-6-chloro-1,3-benzenedisulfonamide 121-30-2 A603375

7-Aminocephalosporanic Acid 957-68-6 A603415

4-Amino-5-chloro-2,1,3-benzothiadiazole 30536-19-7 A603430

4-Amino-2-chloro-6,7-dimethoxyquinazoline 23680-84-4 A603439

2-Amino-6-chloropurine 10310-21-1 A603505

(1S,4R)-4-(2-Amino-6-chloro-9H-purin-9-yl)-2-cyclopentene-1-methanol Hydrochloride

172015-79-1 A603506

3-Amino-4-(2-chlorophenyl)-6-nitro-2(1H)-quinolinone(Clonazepam Impurity)

55198-89-5 A603590

1-Aminocyclopropane-1-carboxylic Acid Methyl Ester Hydrochloride 72784-42-0 A603600

5-Amino-2-cyanobenzotrifluoride 654-70-6 A603630

(1S,4R)-cis-4-Amino-2-cyclopentene-1-methanol D-Tartrate 229177-52-0 A603640

2-Amino-N-cyclohexyl-N-methylbenzylamine 57365-08-9 A603680

7-Amino-1-cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-4-oxo-3-quinolinecarboxylic Acid

172426-88-9 A603780

(1R,3S)-3-[2-Amino-6-(cyclopropylamino)-9H-purin-9-yl]cyclopentanemethanol

208762-35-0 A603795

[2-[(2-Amino-4-chlorophenyl)amino]phenyl](4-methyl-1-piperazinyl)methanone

65514-71-8 A603880

3’-Amino-3’-deoxythymidine 52450-18-7 A604250

Page 6: IMPURITY REFERENCE EP - LGC Ltd€¦ · (Anagrelide Impurity B) 1159977-03-3 A604740 2-Amino-5,6-dichloro-3(4H)-quinazoline Acetic Acid Hydrobromide (Anagrelide Impurity B) 1194434-39-3

6 20 Martin Ross Avenue North York, ON Canada, M3J 2K8

www.trc-canada.com [email protected] +1-416-665-9696

Chemical Name CAS Number Catalog Number

7-Aminodesacetoxycephalosporanic Acid 22252-43-3 A604330

2-(2-Amino-6-(cyclopropylamino)-9H-purin-9-yl)-4-(hydroxymethyl)cyclopentanol A604530

4-[[(2-Amino-3,5-dibromophenyl)methylene]amino]cyclohexanol 1445719-53-8 A604603

trans-4-[[(2-Amino-3,5-dibromophenyl)methylene]amino]cyclohexanol (Ambroxol Impurity C)

50910-53-7 A604605

2-Amino-3,5-dibromo-benzaldehyde 50910-55-9 A604610

2-Amino-3,5-dibromo-benzenemethanol 50739-76-9 A604615

2-Amino-2’,5-dichlorobenzophenone 2958-36-3 A604630

N-(2-Amino-4,6-dichloro-5-pyrimidinyl)formamide 171887-03-9 A604735

2-Amino-5,6-dichloro-3(4H)-quinazoline Acetic Acid(Anagrelide Impurity B)

1159977-03-3 A604740

2-Amino-5,6-dichloro-3(4H)-quinazoline Acetic Acid Hydrobromide(Anagrelide Impurity B)

1194434-39-3 A604745

2-Amino-5,6-dichloro-3(4H)-quinazoline Acetic Acid Ethyl Ester Hydrobromide 70381-75-8 A604755

4-Amino-2,6-dimethoxypyrimidine 3289-50-7 A604928

N-(4-Amino-6,7-dimethoxyquinazol-2-yl)-N-methylpropylenediamine Hydrochloride

81403-69-2 A604970

N-(4-Amino-6,7-dimethoxyquinazol-2-yl)-N-methylpropylenediamine Formamide Hydrochloride

1796934-51-4 A604975

1-[4-(4-Amino-6,7-dimethoxy-2-quinazolinyl)-1-piperazinyl]-5-hydroxy-1-pentanone Hydrochloride

A605020

[4-(4-Amino-6,7-dimethoxy-2-quinazolinyl)-1-piperazinyl][(5S)-tetrahydro-5-methyl-2-furanyl]methanone

1177261-85-6 A605025

1-[4-(4-Amino-6,7-dimethoxy-2-quinazolinyl)-1-piperazinyl]-2-hydroxy-1-pentanone

152551-75-2 A605030

(S)-β-Amino-3-[2-(dimethylamino)ethyl]-1H-indole-5-propanol 139264-69-0 A605065

4-(4-Amino-6,7-dimethoxy-2-quinazolinyl)-1-piperazinecarboxaldehyde Hydrochloride

84050-21-5 A605205

1-(4-Amino-6,7-dimethoxy-2-quinazolinyl)-4-(5-hydroxy-1-oxopentyl)-piperazine

109678-71-9 A605390

1-Amino-3-(3,5-dimethylphenoxy)-2-propanol 66766-07-2 A607300

2-Aminoethyl 4-tert-Butyl-2,6-dimethyl-3-hydroxyphenylacetamideHydrochloride

1391053-50-1 A608890

N-(2-Aminoethyl)-4-(1,1-dimethylethyl)-2,6-dimethylbenzeneacetamide 94266-17-8 A608945

1-(2-Aminoethyl)-cyclohexaneacetic Acid Acetic Acid Salt A609045

3-(2-Aminoethyl)-N-methyl-1H-indole-5-methanesulfonamide (Didesmethyl Sumatriptan)

88919-22-6 A609165

4-Amino-N-[(1-ethyl-2-pyrrolidinyl)methyl]-5-iodo-2-methoxy-benzamide 176849-91-5 A609410

4-Amino-N-(1-ethyl-3-piperidinyl)-5-(ethylsulfonyl)-2-methoxybenzamide 148516-68-1 A609495

(2R,5S)-5-(4-Amino-5-fluoro-2-oxo-1(2H)-pyrimidinyl)-1,3-oxathiolane-2-carboxylic Acid (1R,2S,5R)-5-Methyl-2-(1-methylethyl)cyclohexyl Ester

764659-72-5 A609705

2-Amino-1,7-dihydro-7-[[2-hydroxy-1-(hydroxymethyl)ethoxy]methyl]-6H-purin-6-one

84222-50-4 A610065

[4-(4-Amino-6-hydroxy-7-methoxy-2-quinazolinyl)-1-piperazinyl](tetrahydro-2-furanyl)methanone

105356-89-6 A611450

[4-(4-Amino-7-hydroxy-6-methoxy-2-quinazolinyl)-1-piperazinyl](tetrahydro-2-furanyl)methanone

105356-90-9 A611460

3-[[[2-[(Aminoiminomethyl)amino]-4-thiazolyl]methyl]thio]propanamide 76824-16-3 A611525

Page 7: IMPURITY REFERENCE EP - LGC Ltd€¦ · (Anagrelide Impurity B) 1159977-03-3 A604740 2-Amino-5,6-dichloro-3(4H)-quinazoline Acetic Acid Hydrobromide (Anagrelide Impurity B) 1194434-39-3

7 20 Martin Ross Avenue North York, ON Canada, M3J 2K8

www.trc-canada.com [email protected] +1-416-665-9696

Chemical Name CAS Number Catalog Number

2-Amino-3-hydroxy-2-(hydroxymethyl)propyl Phosphate Barium Salt 114252-50-5 A611560

[2-[2-Amino-3-hydroxy-2-(hydroxymethyl)propoxy]-1-hydroxypropyl]phosphonic Acid, >90%

1262243-11-7 A611565

(4S)-2-[[[(2R)-2-Amino-2-(4-hydroxyphenyl)acetyl]amino]methyl]-5,5-dimethyl-4-thiazolidinecarboxylic Acid (Mixture of Diastereomers)

1356020-01-3 A611620

4-(3-Amino-2-hydroxypropoxy)phenylacetamide 81346-71-6 A611656

5-Aminoimidazole-4-carboxamide Hydrochloride 72-40-2 A611691

2-Amino-α-(methoxyimino)-4-thiazoleacetic Acid 65872-41-5 A611965

1-[2-Amino-1-(4-methoxyphenyl)ethyl]cyclohexanol Hydrochloride 130198-05-9 A611968

4-(Aminomethyl)benzoic Acid 56-91-7 A615230

4-(Aminomethyl)-1-cyclohexene-1-carboxylic Acid (Tranexamic acid Impurity)

330838-52-3 A615530

2-(Aminomethyl)-1-ethylpyrrolidine 26116-12-1 A616165

((1R,4R)-4-(2-Amino-6-chloro-9H-purin-9-yl)cyclopent-2-en-1-yl)methyl Formate A616335

(1R,3S)-3-(2-Amino-6-chloro-9H-purin-9-yl)-cyclopentanemethanol 2022943-79-7 A616340

3-Amino-5-methylisoxazole 1072-67-9 A616920

[4-[(2-Amino-3-methyl-1-oxobutyl)amino]-2-hydroxy-5-phenyl-1-(phenylmethyl) pentyl]-carbamic Acid 5-Thiazolylmethyl Ester

765875-58-9 A617010

[4-[(2-Amino-3-methyl-1-oxobutyl)amino]-2-hydroxy-5-phenyl-1-(phenylmethyl)pentyl]-carbamic Acid 5-Thiazolylmethyl Ester Monohydrochloride

165315-97-9 A617018

4-(Aminomethyl)-1-phenethyl-4-piperidinol 23808-42-6 A617250

4-Amino-6-chloro-N3-methyl-1,3-benzenedisulfonamide 13659-98-8 A617355

2-Amino-4-methylpyridine 695-34-1 A617470

7-Amino-3-[(5-methyl-1,3,4-thiadiazol-2-ylthio)methyl]-3-cephem-4-carboxylicAcid

30246-33-4 A618190

N-(5-Amino-2-methylphenyl)-4-(3-pyridyl)-2-pyrimidineamine 152460-10-1 A618220

2-Amino-5-methylthiazole 7305-71-7 A618235

4-Amino-2-methyl-10H-thieno[2,3-b][1,5]-benzodiazapine, Hydrochloride 138564-60-0 A618255

2-Amino-5-nitro-2'-chlorobenzophenone 2011-66-7 A618410

(S)-N-(1-Amino-1-oxobutan-2-yl)-4-chlorobutanamide 102767-31-7 A618580

2-Amino-5-nitrothiazole 121-66-4 A618650

(6R-trans)-7-Amino-8-oxo-3-[(1H-tetrazol-5-ylthio)methyl]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid

58016-87-8 A618830

(+)-6-Aminopenicillanic Acid 551-16-6 A618895

4-Aminophenol 123-30-8 A618920

2-Aminophenol 95-55-6 A618930

N-[(1S)-2-Amino-2-oxo-1-(phenylmethyl)ethyl]-2-pyrazinecarboxamide 289472-80-6 A622540

4-Aminophenyl-1-phenethylpiperidine 21409-26-7 A625875

(-)-2-Amino-6-propionamido-tetrahydrobenzothiazole 106006-84-2 A628150

5[(R)-(2-Aminopropyl)]-2-methoxybenzenesulfonamide Hydrochloride 112101-75-4 A628700

5-Amino-4-pyrazolecarboxamide 5334-31-6 A628745

Page 8: IMPURITY REFERENCE EP - LGC Ltd€¦ · (Anagrelide Impurity B) 1159977-03-3 A604740 2-Amino-5,6-dichloro-3(4H)-quinazoline Acetic Acid Hydrobromide (Anagrelide Impurity B) 1194434-39-3

8 20 Martin Ross Avenue North York, ON Canada, M3J 2K8

www.trc-canada.com [email protected] +1-416-665-9696

Chemical Name CAS Number Catalog Number

Aminopterin 54-62-6 A628850

2-Aminopyridine 504-29-0 A628985

4-Aminosalicylic Acid 65-49-6 A629220

3-Aminosalicylic Acid 570-23-0 A629260

N-[[7-(Aminosulfonyl)-6-chloro-2,3-dihydro-1,1-dioxo-4H-1,2,4-benzothiadiazin-4-yl]methyl]-6-chloro-3,4-dihydro-1,1-dioxo-2H-1,2,4-benzothiadiazine-7-sulfonamide

402824-96-8 A629375

5-Amino-2-hydroxy-4'-sulfo[1,1'-biphenyl]-3-carboxylic Acid 887256-40-8 A629410

5-(Aminosulfonyl)-2-methoxy-benzoic Acid Methyl Ester 33045-52-2 A629460

[2-[4-(Aminosulfonyl)phenyl]ethyl]carbamic Acid Ethyl Ester 192118-08-4 A629490

5-Amino-1,3,4-thiadiazole-2-sulfonamide Hydrochloride Salt 120208-98-2 A630360

(6R-trans)-7-[[(2-Amino-4-thiazolyl)acetyl]amino]-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid

79350-10-0 A630465

Cefdinir Thiazine Analog Lactone Form

(Mixture of Diastereomers) A630475

2-(((Z)-(1-(2-((2S,3S)-2-((Z)-2-(2-Aminothiazol-4-yl)-2-(((2-carboxypropan-2-yl)oxy)imino)acetamido)-3-(sulfoamino)butanamido)thiazol-4-yl)-2-(((2S,3S)-2-methyl-4-oxo-1-sulfoazetidin-3-yl)amino)-2-oxoethylidene)amino)oxy)-2-methylpropanoic Acid

730928-60-6 A630523

5-Amino-2,4,6-triiodoisophthalic Acid 35453-19-1 A630810

4-Amino Fluconazole Bromide 150168-54-0 A630870

4-Amino-5-[(3,4,5-trimethoxyphenyl)methyl]-2(1H)-pyrimidinone 60729-91-1 A630890

Amisulpride N-Oxide 71676-01-2 A633265

5-Amino-1,3,4-thiadiazole-2-thiol 2349-67-9 A633300

Amlodipine Diethyl Ester 140171-65-9 A633550

Amlodipine Dimethyl Ester 140171-66-0 A633560

L-Amoxicillin 26889-93-0 A634225

Amoxicillin Diketopiperazine 94659-47-9 A634234

APA Amoxicillin Amide 1789703-32-7 A634270

Ampicilloic Acid (>90%) 32746-94-4 A634320

L-(+)-Ampicillin 19379-33-0 A634335

Ampicillin Desoxyazetidin-2-one (~90%) 124774-48-7 A634345

Ampicillin Desoxocarboxylic Acid-[(R)-Phenylglycine] 1207726-28-0 A634355

Ampicillin Amino-benzeneacetaldehyde 10001-82-8 A634375

Ampicillin t-Butyl-demethylbenzenemethanamine 6489-58-3 A634385

(1R,4R)-rel-4-[2-Amino-6-(cyclopropylamino)-9H-purin-9-yl]-2-cyclopentene-1-methanol Hydrochloride

267668-71-3 A634415

(1R,4R)-rel-4-[2-Amino-6-(cyclopropylamino)-9H-purin-9-yl]-2-cyclopentene-1-methanol

783292-37-5 A634440

Amoxicillin Dimer Sodium Salt (>90%) A634510

Anastrozole Diamide 120512-04-1 A637315

Anastrozole Monoamide 120512-03-0 A637325

Page 9: IMPURITY REFERENCE EP - LGC Ltd€¦ · (Anagrelide Impurity B) 1159977-03-3 A604740 2-Amino-5,6-dichloro-3(4H)-quinazoline Acetic Acid Hydrobromide (Anagrelide Impurity B) 1194434-39-3

9 20 Martin Ross Avenue North York, ON Canada, M3J 2K8

www.trc-canada.com [email protected] +1-416-665-9696

Chemical Name CAS Number Catalog Number

Anastrozole Diacid 1338800-81-9 A637355

Anastrozole EP Impurity E (2-[3-(Cyanodimethylmethyl)-5-hydroxymethylphenyl]-2-methylpropionitrile)

120511-88-8 A637428

Anastrozole Mono Acid 1338800-82-0 A637430

Anastrozole Dimer Impurity 1216898-82-6 A637440

Anecortave 7753-60-8 A637640

trans-4-[[(2-Aminophenyl)methyl]amino]cyclohexanol Hydrobromide A637790

Anhydro Erythromycin A 23893-13-2 A638950

9,11-Anhydro Fusidic Acid 74048-41-2 A639500

2',3'-Anhydroinosine 31766-13-9 A648370

Anhydrotetracycline Hydrochloride 13803-65-1 A656050

Anticefepime (>90%) 97164-57-3 A697490

Apixaban 3-Hydroxypropanoic Acid A726545

Ipratropium Iodide A727440

cis-Apovincamine 4880-92-6 A729245

(R,R,R)-Aprepitant 1148113-53-4 A729785

ent-Aprepitant 172822-29-6 A729790

1-β-D-Arabinofuranosyluracil 3083-77-0 A764000

Aripiprazole N1-Oxide 573691-09-5 A771015

Aripiprazole N4-Oxide 573691-11-9 A771020

Aripiprazole Dimer 1797986-18-5 A771025

A77 1726 (E/Z) Mixture 108605-62-5 A771720

A 77-1726 163451-81-8 A771726

α-Artemether 71939-51-0 A777410

L-Aspartyl-L-phenylalanine 13433-09-5 A780128

Ascomycin 104987-12-4 A781000

L-Aspartyl-L-phenylalanine Trifluoroacetic Acid Salt A790008

8-epi Atazanavir 1292296-09-3 A790055

(S,S,S)-Atazanavir Benzylidenehydrazine Carbamate A790120

S-(+)-Atomoxetine Hydrochloride 82857-39-4 A791405

Atorvastatin N-(3,5-Dihydroxy-7-heptanoic Acid)amide 1105067-87-5 A791705

(3S,5R)-Atorvastatin Calcium Salt 887196-25-0 A791720

(3S,5S)-Atorvastatin Sodium Salt 1428118-38-0 A791735

Atorvastatin Acetonide tert-Butyl Ester 125971-95-1 A791745

(3S,5S)-Atorvastatin Calcium Salt 1105067-88-6 A791755

Atorvastatin Lactam Sodium Salt Impurity 148217-40-7 A791775

Atorvastatin Lactone 125995-03-1 A791780

Atorvastatin Lactam Phenanthrene Calcium Salt Impurity (mixture of diastereomers)

148127-12-2 A791815

Page 10: IMPURITY REFERENCE EP - LGC Ltd€¦ · (Anagrelide Impurity B) 1159977-03-3 A604740 2-Amino-5,6-dichloro-3(4H)-quinazoline Acetic Acid Hydrobromide (Anagrelide Impurity B) 1194434-39-3

10 20 Martin Ross Avenue North York, ON Canada, M3J 2K8

www.trc-canada.com [email protected] +1-416-665-9696

Chemical Name CAS Number Catalog Number

Atorvastatin Oxirane Impurity 1246818-88-1 A791850

Atorvastatin Epoxydione Impurity 148146-51-4 A791855

Atorvastatin Epoxy Tetrahydrofuran Impurity 873950-19-7 A791860

cis-Atovaquone 137732-39-9 A793450

(±)-Atovaquone Impurity C 1809464-27-4 A793505

Atropic Acid 492-38-6 A793850

rac 2-Azabicyclo[2.2.1]hept-5-en-3-one 49805-30-3 A795200

(1R)-(-)-2-Azabicyclo[2.2.1]hept-5-en-3-one 79200-56-9 A795205

5-Aza Cytosine 931-86-2 A796375

3'-[3-(3-Azido-2,3-dideoxy-β-D-erythro-pentofuranosyl)-3,6-dihydro-5-methyl-2,6-dioxo-1(2H)-pyrimidinyl]-3'-deoxy-thymidine

148665-49-0 A825005

2-[(2-Azidoethoxy)methyl]-4-(2-chlorophenyl)-3-ethoxycarbonyl-5-methoxycarbonyl)-6-methyl-1,4-dihydropyridine

88150-46-3 A848950

N-(2-(Aziridin-1-yl)ethyl)-2-((2,4-dimethylphenyl)thio)aniline 1928741-86-9 A926985

Azithromycin B 307974-61-4 A927005

Azithromycin N-Oxide 90503-06-3 A927015

Azomycin 527-73-1 A965100

Baccatin III 27548-93-2 B101000

Balsalazide 3-Isomer 1242567-09-4 B116310

Barbituric Acid 67-52-7 B118650

Benazepril Ethyl Ester 103129-58-4 B119815

Beclomethasone 21-Acetate 17-Propionate 5534-08-07 B131015

Beclomethasone 21-Butyrate 17-Propionate B131020

Beclomethasone Dipropionate 5534-09-08 B131030

Beclomethasone 17-Propionate 5534-18-9 B131050

Beclomethasone 21-Propionate 69224-79-9 B131055

Beclomethasone 17-Valerate 52619-18-8 B131065

Beclomethasone 11,17,21-Tripropionate 1709825-83-1 B131075

Bendamustine Ethyl Ester 87475-54-5 B132495

Bendamustine Dimer Impurity 1228551-91-4 B132520

Bendamustine Glycerol Ester B132545

Bendamustine 3-Hydroxyprop-2-yl Ester B132550

Bendamustine 2-Hydroxyprop-1-yl Ester B132555

(R,S)(S,R)-Benidipine Hydrochloride 91599-76-7 B157485

Benzhydrol 91-01-0 B193800

1-Benzhydrylpiperazine 841-77-0 B196950

Benzimidazole 2-Sulfonic Acid 40828-54-4 B197040

1H-Benzimidazole-4-methyl-2-propyl-6-carboxylic Acid 152628-03-0 B197825

Page 11: IMPURITY REFERENCE EP - LGC Ltd€¦ · (Anagrelide Impurity B) 1159977-03-3 A604740 2-Amino-5,6-dichloro-3(4H)-quinazoline Acetic Acid Hydrobromide (Anagrelide Impurity B) 1194434-39-3

11 20 Martin Ross Avenue North York, ON Canada, M3J 2K8

www.trc-canada.com [email protected] +1-416-665-9696

Chemical Name CAS Number Catalog Number

3-(1,2-Benzisothiazolyl) Ziprasidone (Ziprasidone Impurity E)

1159977-04-4 B197875

(5,5’-Bis(2-(4-(benzo[d]isothiazol-3-yl)piperazin-1-yl)ethyl)-6,6’-dichloro-3-hydroxy-3,3’-biindoline-2,2’-dione)

1303996-68-0 B203570

Benzoic Acid 65-85-0 B203900

1-(1H-Benzo[d]imidazol-2-yl)-3-methyl-4-oxo-1,4-dihydropyridine-2-carboxylic acid (>75%)

1163685-30-0 B203960

Benzophenone 119-61-9 B204980

Benzoyl Hydrazine 613-94-5 B208235

3-Benzoyl-α-methylbenzeneacetonitrile 42872-30-0 B208240

(3-Benzoylphenyl)acetonitrile 21288-34-6 B208350

N-(2-Benzoyl-4-chlorophenyl)-2-chloro-N-methylacetamide 6021-21-2 B208405

(2R,3S)-N-Benzoyl-3-phenyl Isoserine 132201-33-3 B208550

2-Benzoylpyridine 1991-02-01 B209570

4-Benzyl Albuterol 56796-66-8 B224750

N-Benzyl Albuterol 24085-03-8 B224760

(R)-4-Benzyl Albuterol 174607-68-2 B224770

5-(2-(Benzylamino)-1-hydroxyethyl)-2-hydroxybenzamide B224855

N-Benzyl Carvedilol 72955-94-3 B233670

6-O-Benzyl-4-dehydroxy-4-dimethylphenylsilyl Entecavir 649761-24-0 B234770

(3R,4S)-1-Benzyl-N,4-dimethylpiperidin-3-amine 1638499-31-6 B276215

(2S,5S)-5-Benzyl-3,6-dioxo-2-piperazineacetic Acid 5262-10-02 B276305

1-Benzyl-3-hydroxyindazole 2215-63-6 B279045

rac-N-Benzyl Formoterol (Mixture of Diastereomers) B279790

Benzylideneacetone 122-57-6 B279975

(R)-N-Benzyl-1-(1-naphthyl)ethylamine 66469-40-7 B285050

4’-O-Benzyloxy Ezetimibe 163222-32-0 B286310

4’-O-Benzyloxy Ezetimibe Diol Impurity 1374250-06-2 B287130

1-Benzyl-4-piperidine-carboxaldehyde 22065-85-6 B288620

Benzyl Phenylephrone Hydrochloride 71786-67-9 B288635

2-(3-(1-Benzylpiperidin-4-yl)-2-oxopropyl)-4,5-dimethoxybenzoic Acid (Donepezil Impurity)

197010-25-6 B288680

1-Benzyltheobromine 55247-90-0 B299500

1-(3,5-Bis(benzyloxy)phenyl)-2-(tert-butylamino)ethan-1-ol B312670

Betamethasone 378-44-9 B327000

Betamethasone 17-Propionate 5534-13-4 B327015

Betamethasone 21-Propionate 75883-07-7 B327020

Betamethasone 21-Phosphate Disodium Salt 151-73-5 B327030

Betamethasone 21-Acetate 17-Propionate 5514-81-8 B327040

16β-Betamethasone 9,11-Epoxide 21-Propionate 205105-83-5 B327045

Page 12: IMPURITY REFERENCE EP - LGC Ltd€¦ · (Anagrelide Impurity B) 1159977-03-3 A604740 2-Amino-5,6-dichloro-3(4H)-quinazoline Acetic Acid Hydrobromide (Anagrelide Impurity B) 1194434-39-3

12 20 Martin Ross Avenue North York, ON Canada, M3J 2K8

www.trc-canada.com [email protected] +1-416-665-9696

Chemical Name CAS Number Catalog Number

Betamethasone Tripropionate 1186048-33-8 B327050

Betamethasone 9,11-Epoxide 17-Propionate 79578-39-5 B327055

Betamethasone 9,11-Epoxide 17,21-Dipropionate 66917-44-0 B327060

Betamethasone 17-Propionate 21-Mesylate 15423-80-0 B327070

Betamethasone 21-Valerate 2240-28-0 B327080

Betamethasone 11,21-Diacetate 330157-05-6 B327100

Betamethasone 9(11)-ene 16125-28-3 B327105

Betamethasone 21-O-Ethyl Carbonate 52619-05-3 B327120

Bezafibrate Ethyl Ester 41859-58-9 B341010

Bicalutamide Sulfide 90356-78-8 B382040

Bicalutamide Sulfoxide 945419-64-7 B382055

Bicarbamic Acid Diisopropyl Ester 19740-72-8 B382150

2,2'-Binaphthalene-6,6'-dicarboxylic Acid 932033-58-4 B386900

Biotin Diacid 57671-79-1 B390600

D-Biotin Dimer Acid 1163708-46-0 B390650

Biperiden Hydrochloride (Mixture of Diastereomers)

1235-82-1 B397825

[1,1'-Biphenyl]-4-yl(phenyl)methanol 7598-80-3 B397915

5-([1,1’-Biphenyl]-4-ylphenylmethyl)-1H-imidazole 91679-37-7 B397925

Biprofen 6341-72-6 B399050

BIRG 613 BS 287980-85-2 B399680

BIRG 616 BS 287980-84-1 B399690

BIRH 414 133627-17-5 B399700

Bis[5-(acetylamino)-1,3,4-thiadiazole-2-sulfonyl]amine 80495-47-2 B400160

2,2’-Bis-(1-adamantyl)-4,4’-dimethoxybiphenyl 932033-57-3 B400900

Bis(aminoethoxy) Amlodipine 721958-74-3 B402100

1,4-Bis(benzhydryl)piperazine 216581-01-0 B408500

N,N’-Bis(1,4-benzodioxane-2-carbonyl)piperazine 617677-53-9 B410505

(3S,4R)-3-[(1,3-Benzodioxol-5-yloxy)Methyl]-4-Phenylpiperidine 324024-00-2 B410575

N,N’-Bis-(benzothiazol-3-yl)piperazine 223586-82-1 B410705

5-Benzyl Dolutegravir B410810

1,3-Bis([1,1’-Biphenyl]-4-ylphenylmethyl)-1H-imidazolium Chloride 66600-13-3 B412700

1,3-Bis(bromomethyl)-5-methylbenzene 19294-04-3 B415030

Bis(2-chloroethyl)amine Hydrochloride 821-48-7 B418800

1,4-Bis[(4-chlorophenyl)phenylmethyl]piperazine Dihydrochloride 856841-95-7 B419060

1,2-Bis[2-(4-Dibenzo[b,f][1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]ethane 1371638-05-9 B419120

1,4-Bis[3,4-dihydro-2(1H)-quinolinon-7-oxy]butane 882880-12-8 B426500

N,N’-Bis(2,3-dihydroxypropyl)-5-nitro-1,3-benzenedicarboxamide 76820-34-3 B426600

Page 13: IMPURITY REFERENCE EP - LGC Ltd€¦ · (Anagrelide Impurity B) 1159977-03-3 A604740 2-Amino-5,6-dichloro-3(4H)-quinazoline Acetic Acid Hydrobromide (Anagrelide Impurity B) 1194434-39-3

13 20 Martin Ross Avenue North York, ON Canada, M3J 2K8

www.trc-canada.com [email protected] +1-416-665-9696

Chemical Name CAS Number Catalog Number

2,6-Bis(3,4-dimethoxyphenyl)-2,6-diisopropylheptanedinitrile B428400

Bis(2-dimethylaminoethyl) Ether 3033-62-3 B429750

Bis[(2-dimethylamino)phenyl]amine Nickel(II) Chloride 1033772-47-2 B429765

α,α-Bis[2-(dimethylamino)ethyl]-4-chlorophenylacetonitrile 1246816-57-8 B429800

N1,N3-Bis[2-(3,4-dimethoxyphenyl)ethyl]-N1,N3-dimethyl-1,3-propanediamine Dihydrochloride

63434-11-7 B429915

(Bis(diphenylmethyl)ether) 574-42-5 B430345

Ethyl 2-Methoxy-5-sulfamoylbenzoate 33045-53-3 B433988

1-Bis(4-fluorophenyl)methyl Piperazine 27469-60-9 B434875

Bis[(2-guanidino-4-thiazolyl)methyl]disulfide (85%) (Famotidine Impurity)

129083-44-9 B439800

1,1-Bis(p-isobutylphenyl)ethane 102120-87-6 B448875

N,N'-Bis(1-methylethyl)Imidodicarbonimidic Diamide Hydrochloride 35708-82-8 B485995

1,3-Bis[(1-methylethyl)amino]-2-propanol 343785-33-1 B486045

4-[1,5-Bis-(2-methylsulfamoylethyl)-1H-indol-3-yl]-1-methylpyridinium Chloride

2144776-33-8 B486100

1,3-Bis(2-methoxyphenoxy)-2-propanol 16929-60-5 B490030

2,2’-Bisnaloxone 211738-08-8 B504250

[2,8-Bis(trifluoromethyl)-4-quinolinyl]-2-pyridinylmethanone 35853-55-5 B505061

1,4-Bis[(tetrahydro-2-furanyl)carbonyl]-piperazine 547730-06-3 B585325

Bis(2-thienyl) Ketone 704-38-1 B585365

2’,7-Bis-O-(Triethylsilyl) 10-Desacetyl Paclitaxel 155556-72-2 B585470

2,5-Bis(2,2,2-trifluoroethoxy)benzoic Acid 35480-52-5 B585485

1,3-Bis-O-(tert-butyldimethylsilyl)calcipotriene 112875-61-3 B585520

N,N-Bis(trifluoromethyl)pyridin-2-amine B585620

(R)-[2,8-Bis(trifluoromethyl)-4-quinolinyl][(2R)-2-piperidinyl]methanol Hydrochloride

58560-52-4 B585700

2-(4-(3-(2',8-Bis(trifluoromethyl)-10H-[3,10'-biphenothiazin]-10-yl)propyl)piperazin-1-yl)ethanol B586700

Bis Valacyclovir (~90%) 1356019-51-6 B588950

Bis(L-Valine) Ester Ganciclovir Trifluoroacetic Acid Salt B588960

(2R,3S)-3-(tert-Boc)amino-1,2-epoxy-4-phenylbutane 98760-08-8 B618531

1-Boc-2-[4-(2-pyridinyl)benzylidene]hydrazine 198904-85-7 B665200

Boldione 897-06-3 B675200

(1R,2R)-Bortezomib 1132709-15-9 B675705

(1S,2S)-Bortezomib 1132709-14-8 B675715

Brimonidine-2,3-dione 182627-95-8 B677525

(S)-Brinzolamide 154127-19-2 B677605

O-Desmethyl Brinzolamide 186377-56-0 B677610

Brobactam S,S-Dioxide 75527-87-6 B677855

Bromazine Hydrochloride 1808-12-4 B678525

Page 14: IMPURITY REFERENCE EP - LGC Ltd€¦ · (Anagrelide Impurity B) 1159977-03-3 A604740 2-Amino-5,6-dichloro-3(4H)-quinazoline Acetic Acid Hydrobromide (Anagrelide Impurity B) 1194434-39-3

14 20 Martin Ross Avenue North York, ON Canada, M3J 2K8

www.trc-canada.com [email protected] +1-416-665-9696

Chemical Name CAS Number Catalog Number

Bromocriptine Methyl Ether 1349233-25-5 B679200

6α-Bromo Beclomethasone Dipropionate 887130-69-0 B680135

Bromo-6-chloro-3,20-dioxopregna-1,4,6-trien-17-yl Acetate B681840

7-(4-Bromobutoxy)-3,4-dihydroquinolin-2-one 129722-34-5 B681960

8-(4-Bromobutyl)-8-azaspiro[4.5]decane-7,9-dione 80827-62-9 B681970

7-(4-Bromobutoxy)-quinoline-2(1H)-one 203395-59-9 B681980

1-(4-Bromobutyl)-3,4-dihydro-7-hydroxy-2(1H)-quinolinone 1424857-68-0 B682055

4-Bromo-2-chlorobenzoic Acid 59748-90-2 B682115

5-Bromodescyano Citalopram 64169-39-7 B683280

5-Bromodescyano Citalopram Hydrobromide 479065-02-6 B683285

10-Bromo-5H-dibenzo[b,f]azepine-5-carboxamide 59690-97-0 B683910

5-(2-Bromoethyl)-2,3-dihydrobenzofuran 127264-14-6 B684233

2-Bromo-6-methoxynaphthalene (Naproxen Impurity N) 5111-65-9 B684780

1-Bromo-3-methyladamantane 702-77-2 B685050

4-(Bromomethyl)benzoic Acid 6232-88-8 B685245

4'-(Bromomethyl)-[1,1'-biphenyl]-2-carboxamide 147404-72-6 B685270

4'-(Bromomethyl)-[1,1'-biphenyl]-2-carboxylic Acid 150766-86-2 B685275

4’-Bromomethylbiphenyl-2-carboxylic Acid, Methyl Ester 114772-38-2 B685305

5-[4’-Bromomethyl-(1,1’-biphenyl)-2-yl]-2-triphenylmethyltetrazole 133051-88-4 B685310

4’-Bromomethyl-2-cyanobiphenyl 114772-54-2 B685335

4’-(Bromomethyl)biphenyl-2-carboxylic Acid tert-Butyl Ester 114772-40-6 B685385

1-[(2S)-3-Bromo-2-methyl-1-oxopropyl]-L-proline 80629-35-2 B685540

3-Bromo-2-methylpropionic Acid 56970-78-6 B685620

(S)-5-Bromo Naproxen 84236-26-0 B685895

5-Bromoquinazolin-6-ylthiourea 842138-74-3 B686940

4,5-Didehydro Brimonidine 151110-15-5 B687180

9α-Bromobudesonide 313474-59-8 B689460

9,11-Anhydrobudesonide

(Mixture of Diastereomers) 313474-58-7 B689470

(S)-(-)-Bupivacaine 27262-47-1 B689546

Buprenorphine Furanyl Impurity (Buprenorphine Impurity I) 89663-73-0 B689595

Buspirone N-Oxide 220747-81-9 B689845

N-(3-Butenyl) Noroxymorphone Hydrochloride 131670-05-8 B689940

2,2'-[Butane-1,4-diylbis(piperazine-1,4-diyl)]dipyrimidine 257877-45-5 B689970

tert-Butyl-(S)-(3-amino-2-oxo-2,3,4,5-tetrahydrobenzo[b]azepin-1-yl) Acetate 109010-60-8 B690350

2-Butyl-4-chloro-1H-imidazole-5-carboxaldehyde 83857-96-9 B690630

2-Butyl-5-chloroimidazole-4-methanol 79047-41-9 B690640

Page 15: IMPURITY REFERENCE EP - LGC Ltd€¦ · (Anagrelide Impurity B) 1159977-03-3 A604740 2-Amino-5,6-dichloro-3(4H)-quinazoline Acetic Acid Hydrobromide (Anagrelide Impurity B) 1194434-39-3

15 20 Martin Ross Avenue North York, ON Canada, M3J 2K8

www.trc-canada.com [email protected] +1-416-665-9696

Chemical Name CAS Number Catalog Number

4-tert-Butylbenzenesulfonamide 6292-59-7 B690735

t-Butylnorsynephrine 96948-64-0 B690810

4-tert-Butylaminoethyl-2-methylphenol 132183-64-3 B690870

2-Butyl-1,3-diazaspiro[4.4]non-1-en-4-one Hydrochloride 151257-01-1 B691030

2-Butyl-3-(3,5-diiodo-4-hydroxybenzoyl)benzofuran 1951-26-4 B691050

4-tert-Butyl-2,6-dimethyl-3-hydroxyphenylacetamide(Oxymetazoline Impurity)

55699-13-3 B691060

2'-O-(tert-Butyldimethylsilyl)-6α-hydroxy 7-epi-Paclitaxel 165065-08-7 B691290

2’-O-(tert-Butyldimethylsilyl)-6α-hydroxy Paclitaxel 211732-86-4 B691300

2'-O-(tert-Butyldimethylsilyl) Paclitaxel 114655-02-6 B691630

16α,17-[(1RS)-Butylidenebis(oxy)]-11β-hydroxy-17-(hydroxymethyl)-D-homoandrosta-1,4-diene-3,17a-dione (Mixture of Diastereomers)

1040085-99-1 B691785

2-Butyl-3-(4-hydroxybenzoyl)benzofuran 52490-15-0 B691950

4-tert-Butyl-2,6-dimethyl-3-hydroxyphenylacetic Acid 55699-12-2 B692010

4-tert-Butyl-3-hydroxy-2,6-dimethylphenylacetonitrile 55699-10-0 B692015

3-tert-Butyl-p-hydroxyanisole 121-00-6 B692085

p-Butyl Ibuprofen Sodium Salt B692200

tert-Butyl Fluvastatin 129332-29-2 B692385

Butyl Itraconazole 89848-51-1 B692500

2’-O-tert-Butyl(dimethyl)silyl-7-O-triethylsilyl-2-debenzoyl-4-desacetyl Paclitaxel

160768-75-2 B692575

2-(p-sec-Butylphenyl)propionic Acid 64451-76-9 B692720

2-(3-(tert-Butylamino)-2-hydroxypropyl)-4-morpholino-1,2,5-thiadiazol-3(2H)-one (>90%)

158636-97-6 B692940

2-(2-Butyl)-4-{4-[4-(4-methyloxy-phenyl)-piperazin-1-yl]-phenyl}-2,4-dihydro-[1,2,4]-triazol-3-one

252964-68-4 B693320

N-(3-N-Butyl)norbuprenorphine 90387-35-2 B693410

4'-[(2-Butyl-4-oxo-1,3-diazaspiro[4.4]non-1-en-3-yl)methyl]-[1,1'-Biphenyl]-2-carbonitrile

138401-24-8 B693590

16α-Butyloxyprednisolone (Budenoside Impurity)

113930-13-5 B693880

N-[2-Butyl-3-[4-[3-(dibutylamino)propoxy]benzoyl]-5-benzofuranyl]formamide 1309381-32-5 B693940

1-(3-Buten-1-yl)-4-(2,3-dichlorophenyl)-piperazine 1424857-93-1 B694150

7-(3-Buten-1-yloxy)-3,4-dihydro-2(1H)-quinolinone 1359829-23-4 B694170

(4-tert-Butyl-2,6-dimethylphenyl)acetonitrile 84803-57-6 B694475

1-tert-Butyl-3,5-dimethylbenzene 98-19-1 B699318

(2-Butyl-5-nitro-3-benzofuranyl)(4-hydroxyphenyl)methanone 141645-16-1 B699890

3-[1-(3-Bromophenyl)-1-hydroxy-n-butyl]benzoic Acid t-Butyl Ester B699930

3-[1-(3-Bromophenyl)-1-hydroxy-n-butyl]benzoic Acid t-Butyl Ester-D9 B699932

2-Bromo-5-fluoro-benzenemethanol 1-Acetate 1839665-96-1 B700180

(2-Butyl-3-benzofuranyl)[3-ethyl-4-[2-(ethylamino)ethoxy]-5-iodophenyl]-methanone B809075

Page 16: IMPURITY REFERENCE EP - LGC Ltd€¦ · (Anagrelide Impurity B) 1159977-03-3 A604740 2-Amino-5,6-dichloro-3(4H)-quinazoline Acetic Acid Hydrobromide (Anagrelide Impurity B) 1194434-39-3

16 20 Martin Ross Avenue North York, ON Canada, M3J 2K8

www.trc-canada.com [email protected] +1-416-665-9696

Chemical Name CAS Number Catalog Number

2-Butoxy-N-[2-(ethylamino)ethyl]-4-quinolinecarboxamide 87864-11-7 B809570

Caffeine 1958-08-02 C080100

(5E)-Calcipotriene 113082-99-8 C144210

(24R)-Calcipotriene 112827-99-3 C144220

(1R)-(-)-10-Camphorsulfonic Acid 35963-20-3 C175045

DL-10-Camphorsulfonic Acid 5872-08-02 C175090

(S)-(+)-Camptothecin 7689-03-4. C175150

Candesartan Ethyl Ester 139481-58-6 C175570

Candesartan 139481-59-7 C175575

Candesartan Methyl Ester 139481-69-9 C175595

Canrenone 976-71-6 C175610

Capecitabine-2',3'-cyclic Carbonate 921769-65-5 C175660

Captopril Disulfide 64806-05-9 C175760

N-Carbamoyl Carbamazepine 1219170-51-0 C175860

Carbendazim 10605-21-7 C175900

N-Carbethoxy-4-piperidone 29976-53-2 C176120

Carbovir Monophosphate 144490-73-3 C177745

Carbovir Triphosphate Triethylamine Salt 1391048-07-9 C177755

2-Carboxybenzoyl Amlodipine 318465-73-5 C177785

(4-Carboxy-3-ethoxy)phenyl Acetic Acid 220438-80-2 C177960

2’-[(1E)-2-[4-[[(2-Carboxyethyl)amino]carbonyl]phenyl]diazenyl] Balsalazide 1346606-53-8 C178015

3-Carboxy-α-methylbenzeneacetic Acid(Ketoprofen Impurity)

68432-95-1 C178745

Carvedilol Bis-carbazole 918903-20-5 C184645

Carvedilol N’-2-Hydroxy-3-[[2-(methoxyphenoxy)ethyl]amine 1076199-79-5 C184650

δ-3 Cefaclor 152575-13-8 C235240

L-Cefadroxil 144790-28-3 C235745

Cefazolin Amide 1322626-65-2 C242515

(E)-Cefdinir 178601-88-2 C242665

Cefetamet 65052-63-3 C242770

(E)-Cefixime (Cefixime EP Impurity D) 97164-56-2 C242820

Cefixime Ethyl Ester Sodium Salt (Cefixime EP Impurity F) C242830

Cefixime EP Impurity A (Technical Grade) (Mixture of Diastereomers)

1614255-90-1 C242840

Cefotaxime Proxetil 217803-89-9 C242935

Cefotaxime Sodium Impurity G C242955

(E)-Cefotaxime 63527-53-7 C242960

Cefpodoxime Acid 80210-62-4 C243850

(E)-Cefpodoxime Proxetil 947692-13-9 C243855

Page 17: IMPURITY REFERENCE EP - LGC Ltd€¦ · (Anagrelide Impurity B) 1159977-03-3 A604740 2-Amino-5,6-dichloro-3(4H)-quinazoline Acetic Acid Hydrobromide (Anagrelide Impurity B) 1194434-39-3

17 20 Martin Ross Avenue North York, ON Canada, M3J 2K8

www.trc-canada.com [email protected] +1-416-665-9696

Chemical Name CAS Number Catalog Number

∆2-Cefpodoxime Proxetil 339528-86-8 C243865

∆2-Ceftazidime (>80%) 1000980-60-8 C244110

Ceftazidime t-Butyl Ester 102772-66-7 C244115

Ceftazidime Methyl Ester (Contains ~10% triethylammonium iodide) 1354396-23-8 C244120

Cefuracetime 39685-31-9 C248040

Cefuracetime (E-isomer) 97232-98-9 C248045

Δ2-Cefuroxime Axetil (Cefuroxime Axetil Delta-3 Isomer)

123458-61-7 C248070

Cefuroxime Axetil Impurity C (85%) 76598-06-6 C248080

Δ2-Cephalexin 79750-46-2 C256810

Cephalomannine 71610-00-9 C258500

7-epi-Cephalomannine 150547-36-7 C258515

Chenodeoxycholic Acid 474-25-9 C291900

(3α,5β,7β)-Cholane-3,7,24-triol 130593-75-8 C292530

4-[4-[[(2R)-3-Chloro-2-hydroxypropyl]amino]phenyl]-3-morpholinone 1252018-10-2 C292820

3-((2-Chloroethyl)amino)propyl Dihydrogen Phosphate 22608-58-8 C293330

7-Chloro-1-ethyl-6-fluoro-1,4-dihydro-4-oxo-3-quinolinecarboxylic Acid EthylEster

70458-94-5 C315510

7-Chloro-6-fluoro-1,4-dihydro-4-oxo-3-quinolinecarboxylic Acid Ethyl Ester 75073-15-3 C315520

Chlorhexidine Diacetate Impurity A 152504-08-0 C334995

Chlorhexidine Diacetate Impurity C 62247-48-7 C335000

2-Chloro-n-(3-methoxyphenyl)acetamide 17641-08-6 C349675

5-Chloro Acesulfame 72827-08-8 C363250

4-[(2-Chloroethyl)(2-methoxyethyl)amino]-L-phenylalanine 573704-40-2 C363295

N-Chloroacetyl DL-Homocysteine Thiolactone 84611-22-3 C363480

1-Chloroadamantane 935-56-8 C363890

3-[[2-[(2-Chloroethyl)amino]ethyl]amino]propyl Monophosphate Dihydrochloride

158401-51-5 C364250

6α-Chlorobeclomethasone Dipropionate 887130-68-9 C364410

4-Chlorobenzhydrol 119-56-2 C364490

3-(4-Chlorobenzal)phthalide 20526-97-0 C364515

3-[4-(4-Chlorobenzoyl)phenoxy]-2-butanone (Fenofibrate Impurity)

217636-47-0 C364540

2-Chlorobenzophenone 5162-03-08 C364575

2-Chlorobenzoic Acid 118-91-2 C364640

4-Chlorobenzoic Acid 1974-11-03 C364650

6-Chloro-4-(2-chlorophenyl)-2-quinazolinemethanol 773871-49-1 C364815

Cetirizine 2-Chloro Impurity Dihydrochloride 83881-59-8 C364840

6-Chloro-4-(2-chlorophenyl)-2-quinazolinecarboxylic Acid 54643-79-7 C364865

(5-Chloro-2,1,3-benzothiadiazol-4-yl)-cyanamide 51322-80-6 C364990

Page 18: IMPURITY REFERENCE EP - LGC Ltd€¦ · (Anagrelide Impurity B) 1159977-03-3 A604740 2-Amino-5,6-dichloro-3(4H)-quinazoline Acetic Acid Hydrobromide (Anagrelide Impurity B) 1194434-39-3

18 20 Martin Ross Avenue North York, ON Canada, M3J 2K8

www.trc-canada.com [email protected] +1-416-665-9696

Chemical Name CAS Number Catalog Number

N-(5-Chloro-2,1,3-benzothiadiazol-4-yl)-thiourea 51323-05-8 C364995

8-(4-Chlorobutyl)-8-azaspiro[4.5]decane-7,9-dione 21098-11-3 C365020

3’-Chloro-2-bromopropiophenone 34911-51-8 C365035

1-(6-Chloro-9H-carbazol-2-yl)ethanone (Carprofen Impurity) 92841-22-0 C365070

7-Chloro-1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-quinoline-3-carboxylic Acid 86393-33-1 C365135

6-Chloro-4-(2-chlorophenyl)-2-quinazolinecarboxaldehyde 93955-15-8 C365200

8-Chloro-5,6-dihydro-11H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-one 31251-41-9 C365245

8-Chloro-5,10-dihydro-11H-dibenzo[b,e][1,4]-diazepin-11-one 50892-62-1 C365250

3’-[4-(5-Chloro-2,3-dihydro-2-oxo-1H-benzimidazol-1-yl)-1-piperidinyl]propyl Domperidine (Domperidine Impurity F)

1391053-55-6 C365315

2-Chloro-2',6'-dimethylacetanilide 1131-01-7 C365375

2-((6-Chloro-2,4-dioxo-3,4-dihydro-2H-pyrimidin-1-yl)methyl)benzonitrile 865758-95-8 C365465

2-[(6-Chloro-3,4-dihydro-3-methyl-2,4-dioxo-1(2H)-pyrimidinyl)methyl]-benzonitrile

865758-96-9 C365470

1-Chloro Dihydro Dutasteride 1365545-42-1 C365475

8-Chloro-5,6-dihydro-5-methyl-6-oxo-4H-Imidazo[1,5-a][1,4]benzodiazepine-3-carboxylic Acid Ethyl Ester

78756-33-9 C365485

6-Chloro-2-cyclopropyl-4-(trifluoromethyl)-quinoline 391860-73-4 C365545

3'-Chloro-3'-deoxythymidine 25526-94-7 C365575

7-Chloro-1-cyclopropyl-4-oxo-6-(piperazin-1-yl)-1,4-dihydroquinoline-3-carboxylic Acid Hydrochloride

526204-10-4 C366030

5-Chlorodescyano Citalopram Hydrobromide 1332724-08-9 C366035

7-Chloro-1-ethyl-6-fluoro-1,4-dihydro-4-oxoquinoline-3-carboxylic Acid, 90% 68077-26-9 C366045

3-(2-Chloroethyl)-2-methyl-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimidin-4-one

63234-80-0 C366155

3-(2-Chloroethyl)octahydro-2-hydroxy-1,3,6,2-oxadiazaphosphonane 2-Oxide 158401-52-6 C366170

3-(2-Chloroethyl)-5-(1H-1,2,4-triazol-1-ylmethyl)-1H-indole 1000673-59-5 C366200

3-(2-Chloroethyl)-6,7,8,9-tetrahydro-9-hydroxy-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one

130049-82-0 C366270

21-Chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregn-4-ene-3,20-dione 17-Propionate

25120-99-4 C366305

21-Chloro-9-fluoro-11β,17-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione17-Propionate

25122-52-5 C366320

(11β)-21-Chloro-9-fluoro-11-hydroxy-16-methylpregna-1,4,16-triene-3,20-dione

1356190-17-4 C366325

8-Chloro-6-(2-fluorophenyl)-1-methyl-6H-Imidazo[1,5-a][1,4]benzodiazepine 59469-74-8 C366400

8-Chloro-6-(2-fluorophenyl)-1-methyl-4H-Imidazo[1,5-a][1,4]benzodiazepine-3-carboxylic Acid

59468-44-9 C366405

3-(2-Chloro-6-fluorophenyl)-5-methylisoxazole-4-carboxylic Acid 3919-74-2 C366475

(11β,16α,17α)-9-Chloro-17-(2,2-dioxido-5H-1,2-oxathiol-4-yl)-17-[(2-furanylcarbonyl)oxy]-11-hydroxy-16-methyl-androsta-1,4-dien-3-one Mometasone Furoate Impurity B

223776-49-6 C366515

(16α)-21-Chloro-17-[(2-furanylcarbonyl)oxy]-16-methyl-pregna-1,4-diene-3,11,20-trione Mometasone Furoate Impurity C

1305334-31-9 C366520

Page 19: IMPURITY REFERENCE EP - LGC Ltd€¦ · (Anagrelide Impurity B) 1159977-03-3 A604740 2-Amino-5,6-dichloro-3(4H)-quinazoline Acetic Acid Hydrobromide (Anagrelide Impurity B) 1194434-39-3

19 20 Martin Ross Avenue North York, ON Canada, M3J 2K8

www.trc-canada.com [email protected] +1-416-665-9696

Chemical Name CAS Number Catalog Number

21-Chloro-17α-[(2-furanylcarbonxyl)oxy]-9β,11β-oxido-16α-methylpregna-1,4-diene-3,20-dioneMometasone Furoate Impurity D

83881-09-8 C366525

5-Chloro Hydrochlorothiazide 5233-42-1 C366550

6β-Chloro-7α-hydroxy-6,7-dihydro Cyproterone Acetate 23814-84-8 C366615

4-Chloro-N-[2-(4-hydroxyphenyl)ethyl]benzamide 41859-57-8 C366660

4-Chloro-4’-hydroxybenzophenone 42019-78-3 C366700

4-(3-Chloro-2-hydroxypropoxy)benzeneacetamide (Atenolol Impurity D)

115538-83-5 C366760

3-Chloroiminodibenzyl 32943-25-2 C366920

6-Chloro Desacetyl Famciclovir C366938

4-Chloro Loratadine 165739-83-3 C366975

7-Chloromethyl Drospirenone 932388-90-4 C366980

7-Chloromethyl 17R-Drospirenone 932388-89-1 C366985

N1-(2-Chloroethyl)-N2-(2-((2,4-dimethylphenyl)thio)phenyl)ethane-1,2-diamine

1928741-88-1 C367303

3-Chloroindomethacin 402849-26-7 C367395

3-Chloro Loxapine 3454-96-4 C367675

rac 1-Chloro-3-[4-(2-methoxyethyl)phenoxy]-2-propanol 56718-76-4 C367980

N-[6-Chloro-5-(2-methoxyphenoxy)-(2,2-bipyrimidine)4-4-yl]-(1,1-dimethylethyl)-benzenesulfonamide

150727-06-3 C368750

2-Chloromethyl-4-(3-methoxypropoxy)-3-methylpyridine Hydrochloride 153259-31-5 C368775

1α-(Chloromethyl) Chlormadinone Acetate 17183-98-1 C369085

2-(Chloromethyl)-4-methoxy-3,5-dimethylpyridine Hydrochloride 86604-75-3 C369240

5-Chloro-1-methyl-4-nitroimidazole 4897-25-0 C369270

N-Chloromethyl Olanzapine Chloride 719300-59-1 C369390

8-Chloro-1-methyl-6-phenyl-4H-imidazo[1,5-a][1,4]benzodiazepine 59467-86-6 C369430

2-(Chloromethyl)-4-methylquinazoline 109113-72-6 C369850

6-Chloro-1-methyl-4-phenyl-2(1H)-quinazolinone 20927-53-1 C370030

2-Chloro-5-(2-fluorophenyl)-1H-pyrrole-3-carbonitrile 1240948-72-4 C370600

(11β,16α)-9-Chloro-11,17-dihydroxy-16-methyl-pregna-1,4-diene-3,20-dione (Mometasone Impurity M)

57780-86-6 C370840

α-(Chloromethyl)-2,4-dichlorobenzyl Alcohol 13692-14-3 C371045

5-(Chloromethyl)-α1,α1,α3,α3-tetramethyl-1,3-benzenediacetonitrile 120511-91-3 C371590

2-Chloro-5-nitrobenzoic Acid 2516-96-3 C374055

4-(5-Chloro-2-oxo-2,3-dihydro-1H-benzimidazol-1-yl)-1-formylpiperidine 1346598-11-5 C374925

2-Chloro Phenothiazine 92-39-7 C374970

1-(3-Chlorophenyl)-4-(3-chloropropyl)piperazine Hydrochloride 57059-62-8 C375105

(4-Chlorophenyl)[4-(1-methylethoxy)phenyl]methanone (Fenofibrate Impurity)

154356-96-4 C375150

2-[(4-Chlorophenyl)acetyl]benzoic Acid 53242-76-5 C375450

4-(p-Chloro-α-phenylbenzyl)-1-piperazineethanol Dihydrochloride 164726-80-1 C377570

Page 20: IMPURITY REFERENCE EP - LGC Ltd€¦ · (Anagrelide Impurity B) 1159977-03-3 A604740 2-Amino-5,6-dichloro-3(4H)-quinazoline Acetic Acid Hydrobromide (Anagrelide Impurity B) 1194434-39-3

20 20 Martin Ross Avenue North York, ON Canada, M3J 2K8

www.trc-canada.com [email protected] +1-416-665-9696

Chemical Name CAS Number Catalog Number

2-Chloro-N-(2,6-dichlorophenyl)-N-phenylacetamide 15308-01-7 C377620

Chlorhexidine Dihydrochloride Impurity B 1308292-89-8 C377680

N-[4-Chloro-2-(phenylamino)phenyl]-N-methylacetamide (Clobazam Impurity) 75524-13-9 C377715

1-(3-Chlorophenyl)-4-(3-chloropropyl)piperazine Hydrochloride 52605-52-4 C377720

p-Chlorophenylcyanoguanidine 1482-62-8 C377735

(2-Chlorophenyl)diphenylmethanol 66774-02-5 C377905

3-(4-Chlorophenyl)glutaramic Acid 1141-23-7 C378130

4-[(4-Chlorophenyl)methyl]-1(2H)-phthalazinone 53242-88-9 C378400

(S)-1-(3-Chlorophenyl)-2-hydroxy-1-propanone 287477-53-6 C378490

1-(3-Chlorophenyl)-2-hydroxy-1-propanone 152943-33-4 C378500

1-(3-Chlorophenyl)-1-hydroxy-2-propanone 857233-13-7 C378505

1-(3-Chlorophenyl)-5-isopropyl Biguanide Hydrochloride 1071546-52-5 C378530

1-[(2-Chlorophenyl)(methylimino)methyl]cyclopentanol 6740-87-0 C378555

4-(4-Chlorophenyl)-2-pyrrolidinone 22518-27-0 C379450

(R)-3-Chloro-1-phenyl-1-(2-methylphenoxy)propane 114446-47-8 C379560

1-[(4-Chlorophenyl)phenylmethyl]piperazine 303-26-4 C379575

1-(3-Chlorophenyl)-1,2-propanedione 10557-17-2 C379645

1-(3-Chlorophenyl)-1,2-propanedione 2-Oxime 56472-71-0 C379648

Chlorproguanil 537-21-3 C379705

5-Chloro-1-(4-piperidinyl)-2-benzimidazolidinone 53786-28-0 C379725

9-[[2-Chloroprop-2-en-1-yl)oxy]methyl]guanine 1797982-93-4 C379785

3'-Chloropropiophenone 34841-35-5 C379845

3-Chloro-4-morpholino-1,2,5-thiadiazole 30165-96-9 C379960

2-[3-(S)-[3-(2-(7-Chloro-2-quinolinyl)ethenyl)phenyl]-3-hydroxypropyl]phenyl-2-propanol

287930-77-2 C379995

Chlorothiazide 58-94-6 C380000

N-(5-Chloro-1,3,4-thiadiazol-2-yl)acetamide 60320-32-3 C380150

(RS, SR) 3-[[2-(4-Chlorophenyl)-2-cyclopentyl-2-hydroxyacetyl]oxy]-1,1-dimethyl pyrrolidinium Bromide

C380158

3-(2-Chlorophenyl)-5-methylisoxazole-4-carboxylic Acid 23598-72-3 C380210

1-(4-Chlorophenyl)-1-phenylethanol 59767-24-7 C380475

N-(3-Chloropropyl)-3,4-dimethoxy-N-methylbenzeneethanamine 36770-74-8 C380945

6-Chloro-pyrimidine-2,4-diamine 156-83-2 C380950

6-Chloro-pyrimidine-2,4-diamine 3-Oxide 35139-67-4 C380955

4-Chloro Trazodone Isomer 157072-19-0 C421650

2-Chloro-N,N-diethylethylamine Hydrochloride 869-24-9 C421850

2-Chlorotrityl Chloride (90%) 42074-68-0 C422260

5-Chlorouracil 1820-81-1 C423775

Chlorpheniramine Nitrile 65676-21-3 C424315

Page 21: IMPURITY REFERENCE EP - LGC Ltd€¦ · (Anagrelide Impurity B) 1159977-03-3 A604740 2-Amino-5,6-dichloro-3(4H)-quinazoline Acetic Acid Hydrobromide (Anagrelide Impurity B) 1194434-39-3

21 20 Martin Ross Avenue North York, ON Canada, M3J 2K8

www.trc-canada.com [email protected] +1-416-665-9696

Chemical Name CAS Number Catalog Number

Chlorpromazine Sulfoxide 969-99-3 C424755

4-Chloro-10-[(dimethylamino)propyl]phenothiazine Hydrochloride 72372-62-4 C428860

4-Chloro-6-[2-(1,1-dimethylethoxy)ethoxy]-5-(2-methoxyphenoxy)-2,2'-bipyrimidine

1177447-87-8 C428995

4-Chloro-6-[2-(1,1-dimethylethoxy)ethoxy]-5-(2-methoxyphenoxy)-2,2'-bipyrimidine-D4 C428997

Cimetidine Amide Dihydrochloride 52568-80-6 C441660

Cimetidine Sulfoxide 54237-72-8 C441680

ent-Cinacalcet Hydrochloride 1217809-88-5 C441805

Cinnamamide 621-79-4 C442018

(Z)-Cinnarizine 750512-44-8 C465290

Citadiol Hydrobromide 103146-26-5 C504800

Citalopram Dimethylaminobutanone Dihydrochloride Salt C504990

(R)-Citalopram Oxalate 219861-53-7 C505015

Citalopram N-Oxide 63284-72-0 C505025

Clarithromycin (9Z)-Oxime 127253-05-8 C559755

Clarithromycin E-9-Oxime 127253-06-9 C559760

Clarithromycin N-Oxide 118074-07-0 C559765

Clarithromycin (9E)-O-Methyloxime 127182-44-9 C559770

Clarithromycin (9Z)-O-Methyloxime 127252-80-6 C559775

Clemastine N-Oxide 108825-05-4 C568505

Clindamycin 2,4-Diphosphate 1309048-48-3 C579995

Clindamycin Hydrochloride 21462-39-5 C580000

Clindamycin B 18323-43-8 C580040

Clobetasol 25122-41-2 C583490

Clobetasone 17-Propionate 25122-56-9 C583535

Clobetasone 54063-32-0 C583551

4,5-Dihydroclobetasone Butyrate 639817-49-5 C583554

2-Bromoclobetasone Butyrate 639817-51-9 C583556

1,2-Dihydroclobetasone Butyrate 639817-48-4 C583557

16α-Methyl Clobetasone Butyrate 25120-98-3 C583559

9-Fluoro-16β-methyl-3,11,20-trioxo-21-(propanoyloxy)pregna-1,4-dien-17-yl Butanoate C583561

17-O-isobutyryl Clobetasone 639817-47-3 C583564

2-Chloro-o-propionotoluidide 19281-31-3 C585500

Clopidogrel Carboxylic Acid Hydrochloride 144750-42-5 C587235

R-(-)-Clopidogrel Hydrogen Sulfate 120202-71-3 C587251

rac-Clopidogrel Hydrochloride 144750-52-7 C587260

Clopidogrel Carboxylic Acid [Methyl (R)-o-chloromandelate] Ester 1421283-60-4 C587320

para-Clotrimazole Isomer 23593-71-7 C587405

Page 22: IMPURITY REFERENCE EP - LGC Ltd€¦ · (Anagrelide Impurity B) 1159977-03-3 A604740 2-Amino-5,6-dichloro-3(4H)-quinazoline Acetic Acid Hydrobromide (Anagrelide Impurity B) 1194434-39-3

22 20 Martin Ross Avenue North York, ON Canada, M3J 2K8

www.trc-canada.com [email protected] +1-416-665-9696

Chemical Name CAS Number Catalog Number

Clozapine N-Oxide 34233-69-7 C587520

7-Chloro-2-methoxy-5-phenyl-3H-1,4-benzodiazepine 31269-33-7 C596135

7-Chloro-2-methoxy-5-phenyl-3H-1,4-benzodiazepine-D3 C596137

N-(2-Chloro-1-oxopropyl)glycine 85038-45-5 C596150

4-(4-(3-(4-Chloro-3-(trifluoromethyl)phenyl)ureido)-3-fluorophenoxy)picolinic Acid

1187945-05-6 C596470

1-Chloro-3-phenylpropane 104-52-9 C596850

Cortisone 1953-06-05 C696500

Cortisone Acetate 1950-04-04 C696510

Crotonobetaine Hydrochloride 6538-82-5 C818805

Cyanamide 420-04-2 C952500

(2E)-2-Cyano-3-(4-hydroxy-3-methoxy-5-nitrophenyl)-2-propenoic Acid 1202160-40-4 C955790

1-Cyano-3-isopropylguanidine 44830-55-9 C955800

2'-Cyano-4-(dibromomethyl)biphenyl 209911-63-7 C978750

(2Z)-2-[Cyano(2,3-dichlorophenyl)methylene]hydrazinecarboximidamide 94213-23-7 C979120

N-Cyano-N',N''-dimethylguanidine 1609-06-9 C979240

(2R)-N-[4-Cyano-3-(trifluoromethyl)phenyl]-3-[(R)-(4-fluorophenyl)sulfinyl]-2-hydroxy-2-methylpropanamide

1080647-25-1 C981305

(2R)-N-[4-Cyano-3-(trifluoromethyl)phenyl]-3-[(S)-(4-fluorophenyl)sulfinyl]-2-hydroxy-2-methylpropanamide

1080647-26-2 C981308

Cyanoguanidine

Metformin Related Compound A USP 461-58-5 C981350

β-(Cyanoimino)-1-piperidinepropanamide 1798387-81-1 C981760

N-Cyano-N’-[2-[(4-methyl-5-imidazolyl)methylthio]ethyl]-S-methylisothiourea 52378-40-2 C981850

3-(Cyanomethyl)benzoic Acid 5689-33-8 C981890

rac 2-Cyano-2-phenylbutanamide 80544-75-8 C982106

2-Cyano-N-[4-(trifluoromethyl)phenyl]acetamide 24522-30-3 C982245

Cyclohexylamine 108-91-8 C984555

2-((Cyclohexanecarbonyl)oxy)acetic Acid 667465-00-1 C986290

7-((1R,2R,3R)-3-(cyclohexylmethoxy)-2-(4,4-difluoro-3-oxooctyl)-5-oxocyclopentyl)heptanoic Acid

C986310

β-1-Cyclohexen-1-yl-4-methoxy-N,N-dimethyl-benzeneethanamine Hydrochloride

93413-79-7 C987338

N-[4-Cyano-3-(trifluoromethyl)phenyl]-2-methyl-2-oxiranecarboxamide 90357-51-0 C987585

Cyclobenzaprine Hydrochloride 6202-23-9 C987750

2-Cyclohexyl-2-hydroxy-phenylacetic Acid 4335-77-7 C987925

N-Cyano-N'-[2-[[(5-methyl-1H-imidazol-4-yl)methyl]thio]ethyl]-carbamimidicAcid Methyl Ester

138035-55-9 C988063

6-Cyclohexyl-4-methyl-2H-pyran-2-one 14818-35-0 C988065

α-Cyclohexyl-α-hydroxy-3-cyclohexene-1-acetic Acid 4-(Diethylamino)-2-butyn-1-yl Ester

1199574-71-4 C988130

3-Cyclohexyl-6,8-dibromo-3-methyl-1,2,3,4-tetrahydroquinazolinium Chloride 1660957-93-6 C988143

Page 23: IMPURITY REFERENCE EP - LGC Ltd€¦ · (Anagrelide Impurity B) 1159977-03-3 A604740 2-Amino-5,6-dichloro-3(4H)-quinazoline Acetic Acid Hydrobromide (Anagrelide Impurity B) 1194434-39-3

23 20 Martin Ross Avenue North York, ON Canada, M3J 2K8

www.trc-canada.com [email protected] +1-416-665-9696

Chemical Name CAS Number Catalog Number

Cyclohexyl Ramipril Analogue 99742-35-5 C988205

1-Cyclohexyl-3-(p-sulfamoylphenethyl)urea 10080-05-4 C988210

N-[4-(β-Cyclohexylureidoethyl)benzensulfonyl] N’-Cyclohexylurea 10079-35-3 C988250

6-[4-(1-Cyclohexyl-1H-tetrazol-5-yl)butoxy]-1-[4-(1-cyclohexyl-1H-tetrazol-5-yl)butyl]-3,4-dihydro-2(1H)-quinolinone

865792-18-3 C988255

N-Cyano-3-(cyanoamino)-N'-methyl-7,8-dithia-2,4,11-triazadodec-2-en-12-imidamide(Cimetidine Impurity)

74886-59-2 C988275

4-[2-(Cyclopropylmethoxy)ethyl]phenol 63659-16-5 C988665

[[4-[2-(Cyclopropylmethoxy)ethyl]phenoxy]methyl]oxirane 63659-17-6 C988670

Cyproterone 2098-66-0 C989090

N6-Cyclopropyl-9-[(1R,4S)-4-[(1,1-dimethylethoxy)methyl]-2-cyclopenten-1-yl]-9H-purine-2,6-diamine

1443421-68-8 C989915

Cyclohexylamine Hydrobromide 26227-54-3 C992140

Cyclohexylamine Hydrochloride 4998-76-9 C992143

L-Cysteine 52-90-4 C995000

L-Cystine 56-89-3 C997860

D 517 Hydrochloride (Verapamil Impurity) 1794-55-4 D100045

N,O-Diacetate Isoacyclovir 91702-60-2 D103100

DAMPA 19741-14-1 D136500

N1,N3-Bis(descyclohexyl) N1,N3-Bis(trans-4-Hydroxy-Cyclohexyl) Daprodustat

1846625-58-8 D193370

Deacetamide Linezolid Azide 168828-84-0 D195600

Deacetylcephalothin 5935-65-9 D198085

Deacetylcephalothin Lactone 10590-10-0 D198215

10-Deacetyl Baccatin III 32981-86-5 D198250

rac 3-Deacetyl-3-butanoyl Acebutolol Hydrochloride 57898-71-2 D198500

16-Deacetyl Fusidic Acid Sodium Salt 55601-53-1 D198950

Deacetyl Ketoconazole 67914-61-8 D198955

Deacetyl Linezolid 168828-90-8 D198960

10-Deacetyl-7-xylosyl Paclitaxel (62%) 90332-63-1 D198965

Deacetyl Linezolid Thioacetamide 216868-57-4 D198970

(2'R)-N2'-Deacetyl-N2'-[4-methyl-4-(methyldithio)-1-oxopentyl]-maytansine 902768-55-2 D199085

N-Debenzoyl-N-[(3E)-hex-3-enoyl] Paclitaxel 502626-06-4 D204050

2-Debenzoyl Paclitaxel 2-Pentanoate 213767-22-7 D204500

N-Debenzoyl-7-{[(2,2,2,-trichloroethyl)oxy]carbonyl} Paclitaxel 114915-15-0 D205125

Debromo Chloro Nicergoline 38536-28-6 D208800

Decarboxy Etodolac 115066-03-0 D215350

Decarboxyl Norfloxacin 75001-82-0 D215375

Decarboxyl Ofloxacin 123155-82-8 D215400

Page 24: IMPURITY REFERENCE EP - LGC Ltd€¦ · (Anagrelide Impurity B) 1159977-03-3 A604740 2-Amino-5,6-dichloro-3(4H)-quinazoline Acetic Acid Hydrobromide (Anagrelide Impurity B) 1194434-39-3

24 20 Martin Ross Avenue North York, ON Canada, M3J 2K8

www.trc-canada.com [email protected] +1-416-665-9696

Chemical Name CAS Number Catalog Number

(R)-De(carboxymethyl) Cetirizine Ethanol Dihydrochloride 728948-88-7 D215510

Decarboxy Ciprofloxacin 105394-83-0 D220500

Decarboxy Enrofloxacin 131775-99-0 D220700

Decarboxy Fexofenadine 185066-37-9 D220750

1-(2-(Decanoyloxy)ethyl)-4-(3-(2-(trifluoromethyl)-10H-phenothiazin-10-yl)propyl)piperazine 1, 4-Dioxide

76005-65-7 D220770

3-Descarboxy Olsalazine 259151-72-9 D221575

Dechloro-acetoxy Bendamustine D226220

3-Dechloro-3-bromo Trazodone Hydrochloride 1263278-80-3 D226260

3-Dechloro-4-chloro Lamotrigine 38943-76-9 D226300

4-Dechloro-4-(4-chlorophenyl) Loperamide 1391052-94-0 D226380

Dechloro Haloperidol 3109-12-04 D226500

rac-cis-3-Dechloro Sertraline Hydrochloride 79559-98-1 D226660

Dechloro Trazodone 62337-66-0 D226700

De(cladinosyl) Clarithromycin 118058-74-5 D226750

3-O-De(cladinosyl)-8,9,10,11-tetradehydro-9-deoxo-11,12-dideoxy-9,12-epoxy Clarithromycin

127157-35-1 D226760

Decladinose Roxithromycin (Roxithromycin Impurity B) 214902-82-6 D226800

Decloxizine Dihydrochloride 13073-96-6 D226850

5-Decyano 5-Carboxymilrinone 80047-38-7 D226885

3-O-Decyclopropyl Roflumilast 1391052-76-8 D226960

De(diethylaminomethyldiiodo) Amiodarone 83790-87-8 D228420

De(diethylaminoethyl-5-iodo) Amiodarone 147030-50-0 D228480

N-Deethyl Dorzolamide 154154-90-2 D228550

rac-trans-4-Defluoro-4-(4-fluorophenyl) Paroxetine Hydrochloride 1217655-87-2 D228690

Defluoro Flunarizine Dihydrochloride 27064-96-6 D228700

4-Defluoro-4-(1H-1,2,4-triazol-1-yl) Fluconazole 871550-15-1 D228850

2-Desfluoro Fluconazole 81886-51-3 D228855

Defluoro Aprepitant 170729-76-7 D228990

Defluoro Levofloxacin 117620-85-6 D229020

Deiodo Amiodarone 85642-08-6 D229025

N-Deformyl-N-acetyl Formoterol Hemifumarate(Mixture of Diastereomers)

D229065

Dehydro Amlodipine Oxalate 1216406-90-4 D229100

6-Dehydrocortisol 600-99-7 D229145

Dehydro Aripiprazole 129722-25-4 D229155

Dehydro Amlodipine 113994-41-5 D229215

14,15-Dehydro Budesonide 131918-64-4 D229300

21-Dehydro Budesonide 85234-63-5 D229305

Page 25: IMPURITY REFERENCE EP - LGC Ltd€¦ · (Anagrelide Impurity B) 1159977-03-3 A604740 2-Amino-5,6-dichloro-3(4H)-quinazoline Acetic Acid Hydrobromide (Anagrelide Impurity B) 1194434-39-3

25 20 Martin Ross Avenue North York, ON Canada, M3J 2K8

www.trc-canada.com [email protected] +1-416-665-9696

Chemical Name CAS Number Catalog Number

1,2-Dihydrobudesonide (Mixture of diastereomers)

137174-25-5 D229330

20,21-Dehydro Spironolactone 132458-33-4 D229405

3,4-Didehydro Alosetron 122852-86-2 D229435

3,4-Dehydro Cilostazol 73963-62-9 D229500

Dehydrodeoxy Donepezil (Donepezil Impurity) 120013-45-8 D229535

5,6-Dehydro-17β-dutasteride 1430804-85-5 D229560

Dehydro Epiandrosterone 3-Acetate 853-23-6 D229590

6,7-Dehydro Ethynyl Estradiol 67703-68-8 D229605

9,11-Dehydro Ethynyl Estradiol 1231-96-5 D229610

6,7-Dehydro Estradiol 7291-41-0 D229620

6-Dehydro Estradiol 17-Valerate 1313382-25-0 D229625

Dehydro Felodipine 96382-71-7 D229650

5,6-Dehydro Finasteride 1329611-51-9 D229655

Dehydro Indapamide 63968-75-2 D229660

Dehydro Lovastatin 109273-98-5 D229685

2,3-Dehydro Ketoconazole 254912-63-5 D229700

Dehydro Mefloquine 68496-04-8 D229710

(2E)-Dehydrodonepezil

(Donepezil Impurity) 145546-80-1 D229775

Dehydro Nicardipine Hydrochloride 1216817-27-4 D229780

Dehydro Nabumetone 127053-22-9 D229795

Dehydro Nifedipine 67035-22-7 D229800

1-Dehydromegesterol Acetate 982-89-8 D229868

Dehydronitroso Nifedipine 50428-14-3 D229890

6,7-Dehydro Norethindrone 31528-46-8 D229915

6(7)-Dehydro Norgestrel 51087-61-7 D229920

8(14)-Dehydro Norgestrel 110785-09-6 D229925

5(6)-Dehydro-4(5)-dihydro D-(-)-Norgestrel (~90%) 100021-05-4 D229935

Dehydro Olmesartan 172875-98-8 D229960

Dehydro Olmesartan Medoxomil 879562-26-2 D229965

6-Dehydro Prednisolone 2427-64-7 D230000

17-Dehydroxy Prednisolone 13479-38-4 D230025

(2E)-2,3-Dehydroxy Atorvastatin 1105067-93-3 D230045

Dehydro Nimodipine 85677-93-6 D230060

14,15-Dehydro Fluocinolone Acetonide D230135

4-Dehydroxy-4-chloro Penciclovir 100199-40-4 D230245

Dehydro Levetiracetam 358629-47-7 D230275

Page 26: IMPURITY REFERENCE EP - LGC Ltd€¦ · (Anagrelide Impurity B) 1159977-03-3 A604740 2-Amino-5,6-dichloro-3(4H)-quinazoline Acetic Acid Hydrobromide (Anagrelide Impurity B) 1194434-39-3

26 20 Martin Ross Avenue North York, ON Canada, M3J 2K8

www.trc-canada.com [email protected] +1-416-665-9696

Chemical Name CAS Number Catalog Number

Dehydro Rifaximin 80621-76-7 D230300

Dehydronitrosonisoldipine 87375-91-5 D230310

Dehydrochenodeoxycholic Acid 859-97-2 D230345

1,6-Dehydro Tramadol 192384-41-1 D230385

3'(6')-Dehydroclindamycin Phosphate 1309349-64-1 D230405

Dehydro Trimipramine 315-69-5 D230410

2-Deiodo Amidotrizoic Acid 162193-52-4 D230435

1,2-Dehydro-3-oxo Rocuronium Bromide 1190105-67-9 D230515

3-Dehydroxy Salbutamol 18910-68-4 D230530

Dehydro Simvastatin 210980-68-0 D230545

Dehydro Venlafaxine 93413-57-1 D230580

7-Dehydroxy Buprenorphine(Buprenorphine Impurity F)

97203-04-8 D230635

4-Dehydroxy-5-hydroxy Ritonavir 202816-62-4 D230645

3-De(hydroxymethyl)-3-methyl Salmeterol 1391054-40-2 D230650

Demethyl Chlorpromazine Hydrochloride 3953-65-9 D230835

rac Desmethyl Citalopram Hydrobromide 1188264-72-3 D230870

N-Demethyl Erythromycin A 992-62-1 D230930

6,7-Demethylene-6,7-dehydro Drospirenone 67372-69-4 D231030

6,7-Demethylene Drospirenone 67372-68-3 D231040

S-Demethyl (E)-S-[4-(4-Fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-ethenyl Rosuvastatin

2226413-62-1 D231085

S-Demethyl S-[4-(4-Fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-hydroxyethyl Rosuvastatin

D231090

N-Demethyl-N-formyl Clarithromycin 127140-69-6 D231135

rac N-Demethyl Promethazine Hydrochloride 60113-77-1 D231220

Demethylpiperazinyl Sildenafil Sulfonic Acid 1357931-55-5 D231235

Demethylpiperazinyl 7-Desoxo 7-Thioxosildenafil Sulfonic Acid 1353018-10-6 D231260

N-Demethyl Trimipramine 2293-21-2 D231350

9-Deoxo-9a-aza-9a-homo Erythromycin A(Desmethyl Azithromycin)

76801-85-9 D231500

3-Dehydroxy Ezetimibe 204589-58-2 D231555

10-Demethoxy Nicergoline 57935-65-6 D231725

11-Deoxy Cortisol 152-58-9 D232600

21-Deoxy Cortisol 641-77-0 D232605

Deoxycholic Acid 83-44-3 D232645

5’-Deoxy-5-fluoro Cytidine 66335-38-4 D232950

5'-Deoxy-5-fluoro-N-[(2-methylbutoxy)carbonyl]cytidine 910129-15-6 D235345

5'-Deoxy-5-fluoro-N-[(3-methylbutoxy)carbonyl]cytidine 162204-30-0 D235350

5’-Deoxy-5-fluorouridine 3094-09-05 D235725

Page 27: IMPURITY REFERENCE EP - LGC Ltd€¦ · (Anagrelide Impurity B) 1159977-03-3 A604740 2-Amino-5,6-dichloro-3(4H)-quinazoline Acetic Acid Hydrobromide (Anagrelide Impurity B) 1194434-39-3

27 20 Martin Ross Avenue North York, ON Canada, M3J 2K8

www.trc-canada.com [email protected] +1-416-665-9696

Chemical Name CAS Number Catalog Number

2'-Deoxyinosine 890-38-0 D239755

3'-Deoxyinosine 13146-72-0 D239760

11-Deoxy Prednisolone 1807-14-3 D249850

2’-O-(5’-Deoxy-β-D-ribofuranosyl) Capecitabine 1262133-66-3 D251000

3’-O-(5’-Deoxy-β-D-ribofuranosyl) Capecitabine 1262133-64-1 D251005

Deoxy Risedronic Acid 75755-10-1 D253800

12-Deoxy Roxithromycin 425365-65-7 D254000

6-Defluoro-piperazinyl 7-Depiperazinyl-chloro Norfloxacin 75001-78-4 D281885

3-Deschloro-4-chloro Bupropion Hydrochloride 1049718-72-0 D281925

4’-Desacetoxy-2’-Acetoxy Bisacodyl 111664-35-8 D281935

Desacetyl Bisacodyl 72901-16-7 D281945

3-Deschloro-3-bromo Bupropion Hydcrochloride 1049718-43-5 D281955

2-(Descyclohexylcarbonyl)-2-benzoyl Praziquantel 54761-87-4 D281965

1,2-Deshydro Praziquantel 125273-86-1 D281975

3-Desamino-3,4-dehydro Sitagliptin 1803026-58-5 D281980

3-Desamino-2,3-dehydro Sitagliptin 1253056-18-6 D281985

rac N-Desbutyroyl Acebutolol 57898-80-3 D282000

2-Deschloro Aripiprazole 203395-82-8 D282020

7-Desmethyl-3-hydroxyagomelatine 166527-00-0 D282150

3-Desethenyl-3-methyl Cefdinir 71091-93-5 D288255

7-(Desacetothioxy)-7-acetodithioperoxy-spironolactone D288270

Desamino Chloroimiquimod 99010-64-7 D288295

Deoxy Venlafaxine 1076199-92-2 D288300

Desamino Imiquimod N-Oxide 99010-63-6 D288305

4'-Deoxy Vincristine 68135-16-0 D288330

4-N-Desacetyl-5-N-acetyl Oseltamivir 956267-10-0 D288370

4-N-Desacetyl-5-N-acetyl Oseltamivir Acid 1391047-93-0 D288375

3-Desacetyl Cefotaxime Lactone (E/Z Mixture) D288390

5-Desamino 5-Oxo-2,5-dihydro Lamotrigine 252186-78-0 D288470

Descarboxyl Levofloxacin 178964-53-9 D288480

Des(oxopentyl) Valsartan Benzyl Ester 676129-93-4 D288495

N-Desaminosulfonyl-N-cyano Famotidine 76823-97-7 D288505

Des(oxopentyl) Valsartan 676129-92-3 D288510

6-Deschloro Cyproterone Acetate 2701-50-0 D288520

6-Deschloro-6,7-epoxy Cyproterone Acetate 15423-97-9 D288530

Deschloro Bupropion Hydrochloride 63199-74-6 D288545

9-Deschloro-9-bromo Beclomethasone Dipropionate 52092-14-5 D288555

Page 28: IMPURITY REFERENCE EP - LGC Ltd€¦ · (Anagrelide Impurity B) 1159977-03-3 A604740 2-Amino-5,6-dichloro-3(4H)-quinazoline Acetic Acid Hydrobromide (Anagrelide Impurity B) 1194434-39-3

28 20 Martin Ross Avenue North York, ON Canada, M3J 2K8

www.trc-canada.com [email protected] +1-416-665-9696

Chemical Name CAS Number Catalog Number

Des(1-cyclohexanol) Venlafaxine 775-33-7 D288590

Des(4-cyclohexyl-L-proline) Fosinopril Acetic Acid 128948-00-5 D288600

Des[4-(2-cyclopropylmethoxy)] Betaxolol Hydrochloride 464877-45-0 D288620

O-Des(cyclopropylmethyl)-O-butyl Betaxolol Hydrochloride D288625

Depropylamino Hydroxy Propafenone 91401-73-9 D288635

Depropylamino Chloro Propafenone 165279-79-8 D288655

Deacetyl Bisacodyl 603-41-8 D288670

Desacetyl Diltiazem 42399-40-6 D288685

O-Desacetyl-N-desmethyl Diltiazem 81353-09-5 D288698

17-Desacetyl Rocuronium Bromide 119302-86-2 D288705

10-Desacetyl Paclitaxel 78432-77-6 D288710

3-Desacetyl Vecuronium Bromide 73319-13-8 D288715

Desethyl Amiodarone Hydrochloride 96027-74-6 D288731

N-Des[2-(2-hydroxyethoxy)ethyl] Quetiapine Dihydrochloride 111974-74-4 D288740

2-Desethoxy-2-hydroxy-1H-1-Ethyl Candesartan Cilexetil 1185255-99-5 D288750

2-Desethoxy-2-hydroxy-2H-2-ethyl Candesartan Cilexetil 1185256-03-4 D288755

Desbenzyl Donepezil Hydrochloride 120013-39-0 D288775

N-Desbutyl Bupivacaine 15883-20-2 D288785

Descarbamoyl Cefuroxime 56271-94-4 D288830

α-Descyclohexyl-α-phenyl Oxybutynin 14943-53-4 D288840

N-Deschlorobenzoyl Indomethacin 2882-15-7 D288845

Descladinose Azithromycin 117693-41-1 D288850

O-Desethyl Candesartan Cilexetil 869631-11-8 D288855

Desethylcarbamoyl Cabergoline 85329-86-8 D288860

Descyclopropyl Abacavir 124752-25-6 D288865

Desbutyl Dronedarone Hydrochloride 197431-02-0 D288875

4-Deschloro-4-(2-furanylmethyl)amino Furosemide 5046-19-5 D288880

Deschloro Cetirizine Dihydrochloride 83881-54-3 D288885

N-Desethyl Brinzolamide 404034-55-5 D288900

3’-Des(dimethylamino)-3’-keto Azithromycin 612069-25-7 D288910

6-Des(diethanolamino)-6-chloro Dipyridamole 54093-92-4 D288935

3-Desethenyl-3-methyl Cefixime (Cefixime EP Impurity E) 72701-01-0 D289065

2-Descarboxy-2-cyano Telmisartan 144702-27-2 D289075

Descarboxy 1-Hydroxy Ketorolac 154476-25-2 D289115

Desethylene Aripiprazole 1216394-63-6 D289125

Desethylene Ciprofloxacin, Hydrochloride 528851-31-2 D289150

Deschloro Aripiprazole 203395-81-7 D289195

Page 29: IMPURITY REFERENCE EP - LGC Ltd€¦ · (Anagrelide Impurity B) 1159977-03-3 A604740 2-Amino-5,6-dichloro-3(4H)-quinazoline Acetic Acid Hydrobromide (Anagrelide Impurity B) 1194434-39-3

29 20 Martin Ross Avenue North York, ON Canada, M3J 2K8

www.trc-canada.com [email protected] +1-416-665-9696

Chemical Name CAS Number Catalog Number

Desethyl Felodipine 123853-39-4 D289240

Desacetyloxyethyl (E)-Cefuroxime Axetil 97232-97-8 D289280

8-Desethyl Etodolac 41339-67-7 D289315

Des [3-(1-Dimethylamino)ethyl] 3-Acetyl Rivastigmine 855300-09-3 D289320

N,N’-Desethylene-N,N’-diformyl Levofloxacin 151377-74-1 D289330

N,N’-Desethylene Levofloxacin Hydrochloride 1346603-62-0 D289350

N,N’-Desethylene Ofloxacin Hydrochloride 1797983-25-5 D289365

5-Descyano Milrinone 5-Carboxyamide 80047-24-1 D289445

(-)-Desethyl Methyl Etodolac 109518-50-5 D289485

3-Des(1-ethylpropoxy)-3-(1-methylpropoxy) Oseltamivir 1052063-37-2 D289490

N-Desethyl-N-propyl Oxybutynin 1215677-72-7 D289500

N8-Desethylcarbamoyl-N1-ethylcarbamoyl Cabergoline 166533-36-4 D289545

21-Deschloro Clobetasol 17-Propionate 4351-48-8 D289573

S-Desethyl S-Methyl Amisulpride 71676-00-1 D289595

Desethyl Sildenafil 139755-91-2 D289600

Desethylene Norfloxacin Hydrochloride 1797116-86-9 D289760

17-Desethynyl Norethindrone Diacetate 66964-58-7 D289765

Desfluorociprofloxacin 93107-11-0 D289820

2’’-Desethyl-2’’-vinyl Simvastatin 1449248-72-9 D289830

rac-cis-3,4-Deschlorosertraline 52758-05-1 D289840

9-Desfluoro-11-deshydroxy-11,12-dehydro Betamethasone 330157-04-5 D289845

rac 5-Desfluoro Voriconazole 182369-73-9 D289870

Defluoro Atorvastatin Calcium Salt 433289-83-9 D289875

Desfluoromethyl Fluticasone Propionate Disulfide 201812-64-8 D289890

17α-Des-(2-hydroxyacetyl)budesonide 17α-Carboxylic Acid 192057-49-1 D289895

Desfluoro Ezetimibe 302781-98-2 D289945

Desfluoro Bicalutamide 90357-05-4 D289955

Deshydroxy Bicalutamide 906008-94-4 D289990

N-Deshydroxy Ciclopirox 67587-24-0 D289995

2’-Des(1-hydroxy-1-methylethyl)-2’-methycarboxy Montelukast 851755-56-1 D290040

Desfluoro Risperidone 106266-09-5 D290065

Desisobutyl-n-butyl Bortezomib 1104011-35-9 D290115

Des(isopropoxyethyl) Bisoprolol 62572-93-4 D290125

rac Des(isopropoxyethyl)-2-isopropoxyethoxymethyl Bisoprolol 1215342-36-1 D290130

rac Des(isopropylamino) Acebutolol Diol 96480-91-0 D290140

Des(isopropylamino) Atenolol Diol 61698-76-8 D290145

O-Desisopropyl-O-methoxyethyl Nimodipine 70172-96-2 D290165

Page 30: IMPURITY REFERENCE EP - LGC Ltd€¦ · (Anagrelide Impurity B) 1159977-03-3 A604740 2-Amino-5,6-dichloro-3(4H)-quinazoline Acetic Acid Hydrobromide (Anagrelide Impurity B) 1194434-39-3

30 20 Martin Ross Avenue North York, ON Canada, M3J 2K8

www.trc-canada.com [email protected] +1-416-665-9696

Chemical Name CAS Number Catalog Number

4,5-Desisopropylidene Topiramate 106881-41-8 D290175

O-Desisopropyl-O-ethyl Bisoprolol Hemifumarate 1346601-75-9 D290180

rac N-Desisopropyl-N-ethyl Acebutolol 441019-91-6 D290185

O-Desisopropyl-O-methyl Bisoprolol Hemifumarate 1346604-00-9 D290190

Des(isopropylthiazolyl) Hydantoin-oxazolidinone Ritonavir 1010809-43-4 D290205

Des(isopropylthiazolyl) Hydantoin Ritonavir (>90%) 1010809-61-6 D290215

2-Desisopropyl-2-ethyl Ritonavir 165315-26-4 D290245

Desloratadine 100643-71-8 D290250

N-Desisopropyl N-Chlorophenylchlorguanide Hydrochloride 13590-98-2 D290335

4-Desmethoxy-4-chloro Omeprazole 863029-89-4 D290390

6β-Deshydroxy-10β-hydroxylevonorgestrel 20402-62-4 D290478

O-Deshydroxyethyl Bosentan 174227-14-6 D290485

4-Desmethoxy Omeprazole 110374-16-8 D290560

4-Desmethoxypropoxyl-4-chloro Rabeprazole 168167-42-8 D290600

4-Desmethoxypropoxyl-4-methoxy Rabeprazole 102804-77-3 D290610

4-Desmethoxypropoxyl-4-methoxy S-Deoxo Rabeprazole 102804-82-0 D290615

Desmethoxy Ranolazine 755711-09-2 D290640

Descyano Cimetidine Dihydrochloride Salt 59660-24-1 D290645

N-Desmethyl Almotriptan 334981-12-3 D290720

α-Desmethyl Anastrozole 1215780-15-6 D290730

Desmethyl Amisulpride Hydrobromide D290755

N-Desmethyl Alosetron 122852-63-5 D290780

C-Desmethyl Atenolol 1797116-92-7 D290800

(R)-Desmethyl Atomoxetine Hydrochloride D290825

8-Deschloro-8-bromo Desloratadine 117796-50-6 D290995

N’-Desmethyl Azithromycin 172617-84-4 D291000

6-Des(1-methyl-2-benzimidazolyl)-6-carboxy Telmisartan 884330-12-5 D291020

Desmethyl Bendamustine Hydrochloride 31349-38-9 D291030

O3-Desethyl Apremilast 1384967-20-7 D291185

Desmethyl Bosentan 253688-61-8 D291275

3-Des(2-methoxyethyl) 3-(1-Methylethyl) Ester Nimodipine 21881-78-7 D291310

Desmethyl rac-Cabastine Hydrochloride 80139-91-9 D291350

Desmethyl Doxylamine 1221-70-1 D291525

Desmethyl Chlorpheniramine Maleate Salt 22630-25-7 D291550

Desmethyl Cyclobenzaprine Hydrochloride 438-59-5 D291560

N-Desmethyl Clarithromycin 101666-68-6 D291575

O-Desmethyl Diltiazem Hydrochloride D291605

Page 31: IMPURITY REFERENCE EP - LGC Ltd€¦ · (Anagrelide Impurity B) 1159977-03-3 A604740 2-Amino-5,6-dichloro-3(4H)-quinazoline Acetic Acid Hydrobromide (Anagrelide Impurity B) 1194434-39-3

31 20 Martin Ross Avenue North York, ON Canada, M3J 2K8

www.trc-canada.com [email protected] +1-416-665-9696

Chemical Name CAS Number Catalog Number

N-Desmethyl Diltiazem Hydrochloride 130606-60-9 D291610

Desmethyl Fluvoxamine 192876-02-1 D291630

3’-N-Desmethyl-3’-N-formyl Azithromycin 612069-28-0 D291635

O-Desmethyl Gatifloxacin 616205-76-6 D291650

3-Desmethyl Gatifloxacin 112811-57-1 D291655

2-Desmethylene-2-chloromethyl Ethacrynic Acid 27929-18-6 D291660

3’-N-Desmethyl-3’-N-tosyl Azithromycin 612069-31-5 D291700

9-Desmethyl endo-Granisetron Hydrochloride 141136-01-8 D291705

S-Desmethyl-S-(2-hydroxy-2-methylpropyl) Rosuvastatin Sodium Salt 1714147-50-8 D291735

S-Desmethyl-S-(2-hydroxy-2-methylpropyl) Rosuvastatin tert-Butyl Ester 1714147-49-5 D291750

rac-Desmethyl Irinotecan Hydrochloride D291805

O-Desmethyl-O-ethyl Albendazole 139751-05-6 D291825

Desmethyl Ketoprofen 22071-22-3 D291830

5-Desmethyl-3-methyl Leflunomide 208401-20-1 D291935

N-Desmethyl 8-Chloro-5H-dibenzo[b,e][1,4]diazepine Clozapine 263366-81-0 D291975

5-O-Desmethyl Donepezil 120013-57-2 D292010

6-O-Desmethyl Donepezil 120013-56-1 D292015

N-Desmethyl Galanthamine 41303-74-6 D292035

1-Desmethyl Granisetron (Granisetron Impurity B) 107007-95-4 D292038

9’-Desmethyl Granisetron 160177-67-3 D292040

N-Desmethyl Imatinib 404844-02-6 D292045

C-Desmethyl Metoprolol 109632-08-8 D292068

O-Desmethyl Metoprolol 62572-94-5 D292073

O-Desmethyl Mycophenolate Mofetil(Impurity A)

1322681-36-6 D292076

1-Desmethyl 2-Methyl Granisetron 127472-42-8 D292085

O-Desmethyl Metoclopramide Hydrochloride 38059-78-8 D292095

Desmethyl Piroxicam (Piroxicam Impurity B) 65897-46-3 D292185

Desmethyl Ofloxacin 82419-52-1 D292270

2-Desmethyl 4-Methyl Prilocaine 744961-76-0 D292285

N-Desethyl N-Methyl rac-Rivastigmine 25081-93-0 D292300

1-Desmethyl-2-methylpropyl Amorolfine 67468-13-7 D292315

Namino-Desmethyl Rivastigmine 923035-05-6 D292375

N-2-Desmethyl Ropivacaine 98626-59-6 D292380

O-Desmethyl O-Isobutyl Nisoldipine D292405

N-Desethyl N-Methyl Rivastigmine 1230021-28-9 D292465

5-Desmethyl-6-methyl Glipizide 66375-96-0 D292550

N-Des(5-methylpyrazinecarbonyl)-N-ethylcarboxyl Glipizide 13554-93-3 D292595

Page 32: IMPURITY REFERENCE EP - LGC Ltd€¦ · (Anagrelide Impurity B) 1159977-03-3 A604740 2-Amino-5,6-dichloro-3(4H)-quinazoline Acetic Acid Hydrobromide (Anagrelide Impurity B) 1194434-39-3

32 20 Martin Ross Avenue North York, ON Canada, M3J 2K8

www.trc-canada.com [email protected] +1-416-665-9696

Chemical Name CAS Number Catalog Number

4-Desmethyl-3-methyl Celecoxib 170570-01-1 D293040

4'-[(1,7'-Dimethyl-2'-propyl[2,5'-bi-1H-benzimidazol]-1'-yl)methyl][1,1'-biphenyl]-2-carboxylic Acid

1026353-20-7 D293045

Des(N’-methyl-2-nitro-1,1-ethenediamino) N’-Methylureido Nizatidine 82586-81-0 D293055

Des(methylsulfonyl) Dronedarone Oxalate 500791-70-8 D293600

(6R,12aS)-N-Desmethyl ent-Tadalafil 929100-66-3 D293805

Des-(N-methyl-5-tetrazolethiolyl)furolactone Cefoperazone 73240-08-1 D294325

Desmethyl Iopamidol 77868-41-8 D295810

N-Desmethyl Zolmitriptan 139264-35-0 D296765

(N,N-Dimethyl-1-butanamine) Zolmitriptan Dimer 1350928-05-0 D296795

Desonide 638-94-8 D296940

3-Des[4-(2-Piperidinyl)ethoxy]benzoyl-7-[4-(2-Piperidinyl)ethoxy]benzoylRaloxifene

1391054-73-1 D297050

N-Des-1-β-D-ribofuranosyl Ribavirin 3641-08-05 D297365

N-Desbispropyl-N-pentyl-2-methyl Ropinirole 249622-60-4 D297370

N-Despropyl Ropivacaine 27262-40-4 D297385

Despyridyl Piroxicam (Piroxicam Impurity C) 24683-25-8 D297415

Desthiazolylmethyl Ritonavir 256328-82-2 D297450

Destolyl Atomoxetine 115290-81-8 D297510

(10E)-10,11-Didehydro-11-deoxy-6-O-methylerythromycin 144604-03-5 D297530

O-Desisopropyl O-Propyl Bisoprolol (Bisoprolol EP Impurity B) 1447715-44-7 D297655

Didestriazole Anastrozole Dimer Impurity 918312-71-7 D297760

N-De(4-sulfonamidophenyl)-N’-(4-sulfonamidophenyl) Celecoxib 331943-04-5 D297915

N-Des-tetrahydrofuran N-(6,7-Dimethoxy-4,4a-dihydroquinazolin-4-amine)Alfuzosin

928780-95-4 D297955

Dexamethasone 9,11-Epoxide 24916-90-3 D298795

Dexamethasone 1950-02-2. D298800

Dexamethasone Acid 37927-01-8 D298805

Dexamethasone Valerate 33755-46-3 D298870

Diacetic Aceclofenac 1216495-92-9 D304530

rac Diacetolol 22568-64-5 D305200

Diacetolol Hydrochloride 73899-76-0 D305210

N,S-Diacetyl-L-cysteine 18725-37-6 D312300

N,N’-Diacetyl-L-cystine, 90% 5545-17-5 D312500

2’,3’-Di-O-acetyl-5’-deoxy-5-fluorocytidine 161599-46-8 D322500

N2,9-Diacetylguanine 3056-33-5 D335000

Diallylacetic Acid 99-67-2 D416010

3,5-Diamino-6-chloropyrazine-2-carboxylic Acid Methyl Ester 1458-01-1 D416240

4-(2,5-Diamino-6-chloropyrimidin-4-ylamino)cyclopent-2-enyl]methanol) 141271-12-7 D416315

Page 33: IMPURITY REFERENCE EP - LGC Ltd€¦ · (Anagrelide Impurity B) 1159977-03-3 A604740 2-Amino-5,6-dichloro-3(4H)-quinazoline Acetic Acid Hydrobromide (Anagrelide Impurity B) 1194434-39-3

33 20 Martin Ross Avenue North York, ON Canada, M3J 2K8

www.trc-canada.com [email protected] +1-416-665-9696

Chemical Name CAS Number Catalog Number

3-[2-(Diaminomethyleneamino)-1,3-thiazol-4-ylmethylsulphinyl]-N-sulphamoyl propanamide (Famotidine Metabolite)

1020719-36-1 D416367

[3-[[[2-(Diaminomethyleneamino)-4-thiazolyl]methyl]thio]propionyl]sulfamide Hydrochloride

76824-17-4 D416369

2,4-Diamino-6-phenyl-7-pteridinol 19152-93-3 D416575

2,4-Diamino-6-piperidinopyrimidine (Desoxyminoxidil) 24867-26-3 D416640

2,7-Diamino-6-phenyl-4-pteridinol 19375-89-4 D416685

2,6-Diaminopurine Hemisulfate 69369-16-0 D416700

2,6-Diamino-4-pyrimidinyl p-Toluenesulfonate 3-Oxide 75105-16-7 D416745

Diaquo[(1R,2R)-1,2-cyclohexanediamine]platinum Dimer Dinitrate 82398-34-3 D416765

2-(4,6-Diamino-1,3,5-triazin-2-yl)sulfanylethanesulfonic Acid 1391054-56-0 D416770

2,6-Diamino-2,3,6-trideoxy-D-ribo-Hexose Dihydrochloride 111170-72-0 D416795

(R)-N-Despropyl Pramipexole 106092-11-9 D416835

(S)-N-Despropyl Pramipexole 106092-09-5 D416840

5-Diazoimidazole-4-carboxamide 7008-85-7 D416883

Dibenzosuberone 1210-35-1 D416940

Dibenzo[b,f][1,4]thiazepine-11-[10H]one 3159-07-7. D416953

2-(2-(4-(Dibenzo[b,f][1,4]thiazepin-11-yl)piperazin-1-yl)ethoxy)ethyl Acetate

Quetiapine Acetate 844639-07-2 D417095

2-(2-(4-(Dibenzo[b,f][1,4]thiazepin-11-yl)piperazin-1-yl)ethoxy)ethanol 848814-27-7 D417105

Di(2-(4-(dibenzo[b,f][1,4]thiazepin-11-yl)piperazin-1-yl))-2-propoxyethyl Propionate

1798840-31-9 D417110

3,5-Diaminosalicylic Acid Dihydrochloride D417180

Di-O-benzoyl L-Tartaric Acid 2743-38-6 D417326

Dibenzosuberol 1210-34-0 D417330

Dibenzhydryl Disulfide 1726-02-9 D417385

(2S)-2-(4-(4-(((2,4-diaminopteridin-6-yl)methyl)(methyl)amino)-N-methylbenzamido)benzamido)pentanedioic Acid

D417435

1-(Diaminomethylene)-3-β-D-ribofuranosyl-urea Picrate 4336-46-3 D417660

2-[2-[2-[2-(4-Dibenzo[b,f][1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]ethoxy]ethoxy]ethanol

1356906-17-6 D418685

2-[2-[2-[2-(4-Dibenzo[b,f][1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]ethoxy]ethoxy]-ethanol Fumarate

D418690

4-Dibenzo[b,f][1,4]thiazepin-11-yl-1-piperazineethanol 329216-67-3 D418698

N-Desmethyl Nicergoline 192504-81-7 D422360

6,6-Dibromopenicillanic Acid 24158-88-1 D425730

6,6-Dibromopenicillanic Acid S,S-Dioxide 76646-91-8 D425735

2,6-Dichloroaniline 608-31-1 D431805

3-(2,3-Dichlorobenzamido) Lamotrigine 252186-79-1 D431860

2,3-Dichlorobenzoic Acid 50-45-3 D431950

2,4-Dichlorobenzoic Acid 50-84-0 D431955

Page 34: IMPURITY REFERENCE EP - LGC Ltd€¦ · (Anagrelide Impurity B) 1159977-03-3 A604740 2-Amino-5,6-dichloro-3(4H)-quinazoline Acetic Acid Hydrobromide (Anagrelide Impurity B) 1194434-39-3

34 20 Martin Ross Avenue North York, ON Canada, M3J 2K8

www.trc-canada.com [email protected] +1-416-665-9696

Chemical Name CAS Number Catalog Number

1-[2-(2,4-Dichlorophenyl)-2-[(3,4-dichlorophenyl)methoxy]ethyl]-1H-imidazole 47447-55-2 D432038

2,4-Dichloro-β-[(2,6-dichlorophenyl)methoxy]benzeneethanamine 1305320-62-0 D434070

2,4-Dichloro-β-[(2,4-dichlorophenyl)methoxy]benzeneethanamine 67358-54-7 D434120

4,8-Dichloro-5,6-dihydro-11H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-one (Loratadine Impurity)

133330-60-6 D434160

2,4-Dichloro-6,7-dimethoxyquinazoline 27631-29-4 D434230

1-[(2,6-Dichlorophenyl)methyl]-1H-imidazole 102993-73-7 D434268

9,11β-Dichloro-17,21-dihydroxy-16β-methyl-pregna-1,4-diene-3,20-dione Dipropionate

14527-61-8 D434285

4,6-Dichloro-5-(2-methoxyphenoxy)-2,2’-bipyrimidine 150728-13-5 D434910

1,3-Dichloro-2-methyl-benzene 118-69-4 D435350

2-[(2,6-Dichlorophenyl)amino]benzaldehyde (Diclofenac impurity) 22121-58-0 D435660

Diclofenac Alcohol (Diclofenac Impurity) 27204-57-5 D435698

(4R)-(3’,4’-Dichlorophenyl)-3,4-dihydro-2H-naphthalen-1-one 155748-61-1 D435708

2-(2,3-Dichlorphenyl)-2-(guanidinylimino)acetonitrile 84689-20-3 D435717

cis-[2-(2,4-Dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methyl p-Tolylsulfonate

134071-44-6 D435718

N-(2,3-Dichlorophenyl)piperazine Hydrochloride 119532-26-2 D435750

rac-1-(2,4-Dichlorophenyl)-2-(1-imidazolyl)ethanol 24155-42-8 D435795

3-(2,6-Dichlorophenyl)-5-methyl-4-isoxazolylcarboxylic Acid 3919-76-4 D435975

2,4-Dichloro-5-sulfamoylbenzoic Acid 2736-23-4 D435980

8-(2,3-Dichlorophenyl)-8-aza-5-azoniaspiro[4.5]decane Bromide 795313-24-5 D436070

(7-(4-{4-[4-(2,3-Dichlorophenyl)piperazin-1-yl]butoxy}butoxy)-3,4-dihydroquinolin-2(1H)-one)

1796928-63-6 D436125

Diclofenac Amide 15362-40-0 D436440

Diclofenac Sodium Salt 15307-79-6 D436450

Diclofenac Isopropyl Ester 66370-79-4 D436458

Diclofenac Acid 15307-86-5 D436465

Diclofenac Monobromo Sodium Salt Impurity 127792-45-4 D436490

Diclofenac Ethyl Ester 15307-77-4 D436495

Diclofenac Methyl Ester 15307-78-5 D436500

Dicloxacilloic Acid 42947-69-3 D436655

(4S)-Dicloxilloic Acid D436660

N,N'-Dicyclohexylurea 2387-23-7 D439365

Dideiodo Amiodarone 23551-25-9 D439420

9,11-Didehydrooestriol 246021-20-5 D439538

Dideoxy Adenosine 4097-22-7 D439850

3,5-Didesamino-3,5-dioxo Lamotrigine 661463-79-2 D440400

Di(N-desethyl) Amiodarone Hydrochloride 757220-04-5 D440750

Didesmethyl Almotriptan 181178-24-5 D440830

Page 35: IMPURITY REFERENCE EP - LGC Ltd€¦ · (Anagrelide Impurity B) 1159977-03-3 A604740 2-Amino-5,6-dichloro-3(4H)-quinazoline Acetic Acid Hydrobromide (Anagrelide Impurity B) 1194434-39-3

35 20 Martin Ross Avenue North York, ON Canada, M3J 2K8

www.trc-canada.com [email protected] +1-416-665-9696

Chemical Name CAS Number Catalog Number

3’-N,N-Di(desmethyl) Azithromycin 612069-27-9 D440850

3’-N,N-Di(desmethyl)-3’-N-formyl Azithromycin 765927-71-7 D440860

2’,3’-Didehydrodidanosine 42867-68-5 D440930

2’,3’-Dideoxy-2,3-didehydroadenosine 7057-48-9 D440935

D,L-N,N-Didesmethyl-N-(4-methoxyphenethyl) Venlafaxine 1329795-88-1 D441150

2-(Diethylamino)-N-(2,4-dimethylphenyl)acetamide Hydrochloride 17289-54-2 D441920

3-(Diethylboryl)pyridine 89878-14-8 D442040

2-(Diethylamino)-N-(2,5-dimethylphenyl)acetamide Hydrochloride 1012864-23-1 D443595

N,N-Diethylethylenediamine (2-Diethylaminoethylamine)

100-36-7 D443635

2-(Diethylamino)-N-(2,3-dimethylphenyl)acetamide Hydrochloride 857170-72-0 D443745

7,11-Diethyl-10-hydroxycamptothecin 947687-01-6 D444425

3,10-Diethyl-11,13-dihydro-3-hydroxy-13-oxo-1H,3H-furo[3',4':6,7]indolizino[1,2-b]quinolin-8-yl Ester [1,4'-Bipiperidine]-1'-carboxylic Acid

143490-54-4 D444453

Diethyl-2-propylimidazole-4,5-dicarboxylate 144689-94-1 D444795

1,8-Diethyl-1,3,4,9-tetrahydro-pyrano[3,4-b]indole-1-acetic Acid Methyl Ester 122188-02-7 D445035

1,4-Di-2-furoyl-piperazine 31350-27-3 D445090

Difenoxin Hydrochloride 35607-36-4 D445400

Difluoro Atorvastatin Calcium Salt 693793-53-2 D445645

2,4-Difluorobenzoyl Risperidone Impurity 158697-67-7 D445715

2’,2’-Difluoro-2’-deoxyuridine 114248-23-6 D445740

9,10-Difluoro-2,3-dihydro-3-methyl-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic Acid (RS-Ofloxacin Carboxylic Acid)

82419-35-0 D445745

6α,9α-Difluoro-11β-hydroxy-16α-methyl-3-oxo-17α-(propionyloxy)-androsta-1,4-diene-17β-carbothioic Acid

80474-45-9 D445765

5-(Difluoromethoxy)-2-mercapto-1H-benzimidazole 97963-62-7 D445835

8-Desmethoxy-8-fluoro Moxifloxacin 151213-15-9 D445850

2,4-Difluoro-α-(1H-1,2,4-triazolyl)acetophenone 86404-63-9 D445885

1-[2-(2,4-Difluorophenyl)-2,3-epoxypropyl]-1H-1,2,4-triazole 86386-76-7 D446045

2-(2,4-Difluorophenyl)-3-(1H-1,2,4-triazol-1-yl)-1,2-propanediol 118689-07-9 D446080

(6α,11β,16α,17α)-6,9-Difluoro-11-hydroxy-16-methyl-spiro[androsta-1,4-diene-17,5'-[1,3]oxathiolane]-2',3,4'-trione

219719-95-6 D446130

(6α,11β,16α,17α)-6,9-Difluoro-11-hydroxy-16,17-[(1-methylethylidene)bis(oxy)]-3-oxoandrosta-1,4-diene-17-carboxylic Acid

65751-34-0 D446155

11,17-Difuroate Mometasone Furoate Mometasone Furoate Impurity E

1370190-33-2 D446190

(2RS,3RS)-α-(2,4-Difluorophenyl)-5-fluoro-β-methyl-α-(1H-1,2,4-triazol-1-ylmethyl)-4-pyrimidineethanol

182230-43-9 D446315

1,2-Dihydro Prednicarbate 671225-26-6 D446435

9,10-Dihydroergostine 3609-19-6 D446445

Digoxigenin Tetradigitoxoside 31539-05-6 D446510

Page 36: IMPURITY REFERENCE EP - LGC Ltd€¦ · (Anagrelide Impurity B) 1159977-03-3 A604740 2-Amino-5,6-dichloro-3(4H)-quinazoline Acetic Acid Hydrobromide (Anagrelide Impurity B) 1194434-39-3

36 20 Martin Ross Avenue North York, ON Canada, M3J 2K8

www.trc-canada.com [email protected] +1-416-665-9696

Chemical Name CAS Number Catalog Number

2-[[3-[2-(Dimethylamino)ethyl]-1H-indol-5-yl]methyl] Sumatriptan 545338-89-4 D446670

N-(2,6-Dimethylphenyl)acetamide 2198-53-0 D446680

Dimethylamine Hydrochloride 506-59-2 D446730

3,4-Dihydro Ivermectin (Mixture of Diastereomers) 74567-01-4 D446820

2',4'-Difluorobiphenyl-4-ol 59089-68-8 D447370

3,7-Dihydro-3-methyl-1,7-bis(5-oxohexyl)-1H-purine-2,6-dione 200556-62-3 D447468

2-(2,4-Difluorophenyl)-1-(1H-1,2,4-triazol-1-yl)-3-bromopropan-2-ol 150194-52-8 D448110

3,4-Dihydroagomelatine 1352139-51-5 D448255

(-)-Dihydroapovincaminic Acid Ethyl Ester 57327-92-1 D448350

1,2-Dihydro Beclomethasone Dipropionate 114371-33-4 D448400

1-[(2,3-Dihydro-1,4-benzodioxin-2-yl)carbonyl]piperazine Monohydrochloride 70918-74-0 D448445

4a,5-Dihydro Lovastatin 77517-29-4 D448570

6,7-Dihydrocanrenone 976-70-5 D448720

3,4-Dihydro-7-(3’carboxy)propoxy-2(1H)-quinolinone 58899-27-7 D448725

4,7-Dihydro Megestrol Acetate 14994-27-5 D448760

10,11-Dihydro Carbamazepine 3564-73-6 D448765

Dihydrocephalomannine 159001-25-9 D448770

10,11-Dihydro-5H-dibenzo[b,f]azepine 494-19-9 D448870

3,7-Dihydro-3,7-dimethyl-6-[(5-oxohexyl)oxy]-2H-purin-2-one 93079-86-8 D448890

(E)-Dihydro Efavirenz 440124-96-9 D448935

Dihydro FK-506 104987-30-6 D448950

Dihydro Finasteride 98319-24-5 D448975

Dihydro Donepezil (Mixture of Diastereomers)

120012-04-6 D449095

1,4-Dihydro-2,6-dimethyl-4-(3-nitrophenyl)-3,5-pyridinedicarboxylic Acid 3-Methyl Ester

74936-72-4 D449123

3,4-Dihydro-7-hydroxyquinoline-2(1H)-one 22246-18-0 D449145

5,10-Dihydro-2-methyl-4H-thieno[2,3-b][1,5]benzodiazepin-4-one (Olanzapine Impurity)

221176-49-4 D449185

5,6-Dihydro-3-(methylamino)-2H-1,4-thiazin-2-one Oxime Hydrochloride 112233-23-5 D449435

3-[3-(2,3-Dihydro-2-oxo-1H-benzimidazol-1-yl)propyl] Domperidone (Domperidone Impurity D)

1614255-34-3 D449455

3’-[3-(2,3-Dihydro-2-oxo-1H-benzimidazol-1-yl)propyl] Domperidone (Domperidone Impurity E)

1346602-50-3 D449465

1,2-Dihydro Exemestane 19457-55-7 D449515

1,2-Dihydro Exemestane-d7 13C D449517

3,4-Dihydro-7-(4-hydroxybutoxy)-2(1H)-quinolinone 889443-20-3 D449540

1,2-Dihydro Fluticasone Propionate 105613-90-9 D449635

20-Dihydroprogesterone Acetate 5062-62-4 D449690

20β-Dihydroprogesterone 145-15-3 D449750

Page 37: IMPURITY REFERENCE EP - LGC Ltd€¦ · (Anagrelide Impurity B) 1159977-03-3 A604740 2-Amino-5,6-dichloro-3(4H)-quinazoline Acetic Acid Hydrobromide (Anagrelide Impurity B) 1194434-39-3

37 20 Martin Ross Avenue North York, ON Canada, M3J 2K8

www.trc-canada.com [email protected] +1-416-665-9696

Chemical Name CAS Number Catalog Number

4,5-Dihydro Mometasone Furoate 6-Acetate D450000

4α,5-Dihydro Simvastatin D450010

N-[2-(3,4-Dihydro-1-oxo-2(1H)-isoquinolinyl)-2-oxoethyl]-N-formyl-cyclohexanecarboxamide

125273-88-3 D450080

2,3-Dihydro-5,6-dimethoxy-2-[(1-oxido-4-pyridinyl)methylene]-1H-inden-1-one

896134-06-8 D450165

(E)-N-[2-(3,4-Dihydro-7-methoxy-1(2H)-naphthalenylidene)ethyl]acetamide (Agomelatine Impurity)

178677-39-9 D450485

2,5-Dihydroxybenzoic Acid 490-79-9 D451655

3,4-Dimethoxy-N-methyl-benzeneethanamine Hydrochloride 13078-76-7 D452050

Dihydroxy Diketo Atorvastatin Impurity 1046118-44-8 D452740

N-(4,5-Dihydro-1H-imidazol-2-yl)-6-quinoxalinamine 91147-43-2 D452880

(6,11-Dihydro-5H-dibenzo[b,e]azepin-6-yl)methanamine 41218-84-2 D452983

(16β)-17,21-Dihydroxy-16β-methyl-pregna-1,4,9(11)-triene-3,20-dione 13504-15-9 D453255

5,6-Dihydro Midazolam 59468-07-4 D453380

Dihydroxy Moxonidine 352457-32-0 D453460

3,4-Dihydroxy-5-nitrobenzaldehyde 116313-85-0 D453650

[R-(R*,R*)]-(1,2-Dihydroxypropyl)phosphonic Acid 132125-60-1 D454455

P-[(1R,2R)-1,2-Dihydroxypropyl]-phosphonic Acid Ammonium Salt 1160525-87-0 D454560

1-[(2β,3α,5α,16β17β)-3,17-Dihydroxy-2-(1-piperidinyl)androstan-16-yl]-1-methyl piperidinium Bromide

73319-30-9 D454600

3,3’-Diiodo-L-thyronine 4604-41-5 D455150

3,5-Diiodo-L-thyronine 1041-01-6 D455155

2,6-Diisopropyl-1,4-benzoquinone 1988-11-0 D455245

N,N’-Diisopropylethylenediamine 4013-94-9 D455285

2,4-Diisopropylphenol 2934-05-06 D455290

2,5-Diisopropylphenol 35946-91-9 D455390

Dimethyl (2-Oxo-4-phenylbutyl)phosphonate 41162-19-0 D455445

3,4-Dimethyldiphenylamine 17802-36-7 D456920

(S)-1-[(1,1-Dimethylethyl)amino]-3-[[4-[(2-hydroxyethyl)amino]-1,2,5-thiadiazol-3-yl]oxy]-2-propanol

75014-26-5 D457485

6,7-Dimethoxy-N2,N2-dimethylquinazoline-2,4-diamine 19216-53-6 D460340

3,4-Dimethoxybenzyl Alcohol 1993-03-08 D460555

(2R-trans)-Diltiazem Hydrochloride 103532-27-0 D460570

Dimesna 16208-51-8 D460660

3,4-Dimethoxybenzaldehyde 120-14-9 D460663

5,6-Dimethoxy-2-(4-pyridylmethyl)-1-indanone 4803-57-0 D460708

5,6-Dimethoxy-2-(4-pyridylmethylene)-1-indanone (Donepezil Impurity) 4803-74-1 D460720

1,3-Dimethyladamantane 702-79-4 D460778

Page 38: IMPURITY REFERENCE EP - LGC Ltd€¦ · (Anagrelide Impurity B) 1159977-03-3 A604740 2-Amino-5,6-dichloro-3(4H)-quinazoline Acetic Acid Hydrobromide (Anagrelide Impurity B) 1194434-39-3

38 20 Martin Ross Avenue North York, ON Canada, M3J 2K8

www.trc-canada.com [email protected] +1-416-665-9696

Chemical Name CAS Number Catalog Number

Dimethylaminomethylfurylmethylthioethyl Ranitidine 72126-78-4 D460980

2-(Dimethylaminomethyl)-4-(2-aminoethylthiomethyl)thiazole 78441-62-0 D461050

4-Dimethylaminobutyraldehyde Diethyl Acetal 1116-77-4 D461095

3,4-Dimethoxy-α-[3-(methylamino)propyl]-α-(1-methylethyl)-benzeneacetonitrile Hydrochloride

67775-97-7 D461275

1-[3-(Dimethylamino)propyl]-1-(4-fluorophenyl)-1,3-dihydro-5-isobenzofurancarboxamide

64372-56-1 D461420

Dimethylamine (~2.0 M in THF) 124-40-3 D461480

4-[4-(dimethylamino)-1-(4-fluorophenyl)-1-buten-1-yl]-3-(hydroxymethyl)-benzonitrile (Citalopram Olefinic Impurity)

920282-75-3 D461550

α-[2-(Dimethylamino)-1-methylethyl]-α-phenyl-Benzeneethanol 1-Acetate 53990-51-5 D461675

2-(((5-((Dimethylamino)methyl)furan-2-yl)methyl)thio)ethanamine Fumarate (2:1)

256948-32-0 D461735

11-[3-(Dimethylamino)propyl]-6,11-dihydrocibenz[b,e]oxepin-11-ol 4504-88-5 D461765

3-Dimethylamino-1-(3-pyridyl)-2-propen-1-one 55314-16-4 D462145

N,3-Dimethylaniline 696-44-6 D462180

2,3-Dimethylaniline 87-59-2 D462190

2,6-Dimethylaniline 87-62-7 D462195

2,6-Dimethylaniline Hydrochloride 21436-98-6 D462200

3-Deoxy-3-acetylabiraterone-4,6-ene D462420

α-[3-[[2-(3,4-Dimethoxyphenyl)ethyl]methylamino]propyl]-3,4-dimethoxy-α-propylbenzeneacetonitrile

959011-16-6 D462508

3,3-Dimethyl Clobazam D464955

Dimethyl 4-(2-Chlorophenyl)-2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylate

43067-01-2 D469350

α,α'-[[[2-(3,4-Dimethoxyphenyl)ethyl]imino]di-3,1-propanediyl]bis[3,4-dimethoxy-α-(1-methylethyl)benzeneacetonitrile Monohydrochloride

190850-50-1 D470505

3,5-Dimethyl-1-adamantanol 707-37-9 D470580

6,8-Dimethoxy Moxifloxacin Hydrochloride D470600

1,7-Di(2-methoxyphenoxy)-2,6-dihydroxy-4-oxaheptane 1797132-23-0 D470665

2-(3,4-Dimethoxyphenyl)-N-methylethylamine 3490-06-0 D470710

5-[3-(Dimethylamino)propyl]-10,11-dihydro-5H-dibenzo[a,d]cyclohepten-5-ol 1159-03-1 D470770

5-(Dimethylaminomethyl)-2-furfuryl Alcohol Hydrochloride 81074-81-9 D470845

2-(Dimethylamino)thioacetamide Hydrochloride 27366-72-9 D470990

2-[(Dimethylamino)methyl]-4-thiazolemethanol 78441-69-7 D471005

3-[2-(Dimethylamino)ethyl]-5-[(1-pyrrolidinylsulfonyl)methyl]-1H-indole-1-methanol

1018676-02-2 D471090

(S)-3-[2-(Dimethylamino)ethyl]-5-[[(4S)-2-oxo-4-oxazolidinyl]methyl]-1H-indole-2-carboxylic Acid Ethyl Ester

191864-24-1 D471210

3-[(Dimethylamino)methyl]-1,2,3,9-tetrahydro-9-methyl-4H-carbazol-4-one Hydrochloride

119812-29-2 D471400

N-[(1S,2S,4S)-4-[[(1,1-Dimethylethoxy)carbonyl]amino]-2-hydroxy-5-phenyl-1-(phenylmethyl)pentyl]carbamic Acid 5-Thiazolylmethyl Ester

162849-95-8 D472785

Page 39: IMPURITY REFERENCE EP - LGC Ltd€¦ · (Anagrelide Impurity B) 1159977-03-3 A604740 2-Amino-5,6-dichloro-3(4H)-quinazoline Acetic Acid Hydrobromide (Anagrelide Impurity B) 1194434-39-3

39 20 Martin Ross Avenue North York, ON Canada, M3J 2K8

www.trc-canada.com [email protected] +1-416-665-9696

Chemical Name CAS Number Catalog Number

6,11-Di-O-methyl Erythromycin 81103-14-2 D472905

N-[(2E)-6,6-Dimethyl-2-hepten-4-yn-1-yl]-N-methyl-2-naphthalenemethanamine Hydrochloride

877265-30-0 D473210

N-[(2E)-6,6-Dimethyl-2-hepten-4-yn-1-yl]-N,4-dimethyl-1-naphthalenemethanamine Hydrochloride

877265-33-3 D473215

(S)-4-[4-(Dimethylamino)-1-(4-fluorophenyl)-1-hydroxybutyl]-3-(hydroxymethyl)-benzonitrile Di-p-toluoyl-D-tartrate Salt (2:1)

128173-53-5 D474065

trans-[2-(2,4-Dichlorophenyl)-2-(1H-1,2,4-triazol-1-yl-methyl)-1,3-dioxolan-4-yl]methyl Methanesulfonate

854372-78-4 D474178

cis-[2-(2,4-Dichlorophenyl)-2-(1H-1,2,4-triazol-4-yl-methyl)-1,3-dioxolan-4-yl]methyl Methanesulfonate

103661-14-9 D474183

3-[2-(2,4-Dichlorophenyl)-2-hydroxyethyl]-1-[[4-(phenylthio)phenyl]methyl]-1H-imidazolium Chloride

80639-93-6 D474195

2,2-Dimethyl-4-isopropyl-1,3-benzodioxole 201166-22-5 D474200

N,N-Dimethylmelamine

Metformin Impurity C 1985-46-2 D474600

3,4-Dimethoxy-α-(1-methylethyl)benzeneacetonitrile 20850-49-1 D474780

(2R,6S)-rel-2,6-Dimethyl-4-(2-methyl-3-phenylpropyl)morpholine Hydrochloride

922734-43-8 D474815

N,N'-Dimethyl-2-nitro-1,1-ethenediamine 54252-45-8 D474850

β,2-Dimethyl-5-nitro-1H-imidazole-1-ethanol 56750-04-0 D474905

6,7-Dimethoxyquinazoline-2,4-dione 28888-44-0 D474950

(αS)-3-[2-(2,6-Dimethylphenoxy)acetyl]-N-[(1S,3S,4S)-4-[[2-(2,6-dimethylphenoxy)acetyl]amino]-3-hydroxy-5-phenyl-1-(phenylmethyl)pentyl]tetrahydro-α-(1-methylethyl)-2-oxo-1(2H)-pyrimidineacetamide

943250-66-6 D476505

(R)-α-[(2,2-Dimethyl-1-oxopropyl)amino]-4-hydroxybenzeneacetic Acid 205826-86-4 D476555

N-(2,6-Dimethylphenyl)-2-(ethylmethylamino)acetamide Hydrochloride 50295-20-0 D476800

3,4-Dimethoxy-N,N-dimethylbenzeneethanamine Hydrochloride 51012-67-0 D476830

N,N'-bis(2,6-Dimethylphenyl)-1,4-piperazinediacetamide 380204-72-8 D477030

N-(2,3-Dimethylphenyl) Mefenamic Acid Carboxamide 21122-68-9 D477945

2-[(4,6-Dimethyl-2-pyrimidinyl)oxy]-3,3-diphenyl-2-propenoic Acid 1312092-82-2 D479015

2,6-Dimethyl-4-tert-butylphenylacetic Acid 854646-92-7 D479020

4-Dimethylaminopyridine 1122-58-3 D479025

1-(3,4-Dimethoxyphenyl)-2-methyl-1-propanone 14046-55-0 D479195

[N(Z)]-N-(3,5-Dimethyl-2(3H)-thiazolylidene)-4-hydroxy-2-methyl-2H-1,2-benzothiazine-3-carboxamide 1,1-Dioxide

1262333-25-4 D479475

(3S,10R,13S)-10,13-dimethyl-17-(trifluoromethylsulfonyloxy)-2,3,4,7,8,9,10,11,12,13,14,15-dodecahydro-1Hcyclopenta[a]phenanthren-3-yl 2,2,2-trifluoroacetate

1802323-89-2 D479868

O,O-Di-2-Naphthalenyl Ester Carbonothioic Acid 127084-74-6 D479930

Dimethyl 2,6-Dimethyl-4-phenyl-1,4-dihydropyridine-3,5-dicarboxylate 70677-78-0 D480208

4',6'-Dinitro-2'-phenoxymethanesulfonanilide 51765-56-1 D480760

Diosmetin 520-34-3 D485000

9,10-Dioxo Ketotifen 43076-16-0 D486510

Page 40: IMPURITY REFERENCE EP - LGC Ltd€¦ · (Anagrelide Impurity B) 1159977-03-3 A604740 2-Amino-5,6-dichloro-3(4H)-quinazoline Acetic Acid Hydrobromide (Anagrelide Impurity B) 1194434-39-3

40 20 Martin Ross Avenue North York, ON Canada, M3J 2K8

www.trc-canada.com [email protected] +1-416-665-9696

Chemical Name CAS Number Catalog Number

N,N-Diphenylcarbamyl Chloride 1983-01-02 D487340

2,2-Diphenylglycine 3060-50-2 D491620

2,2-Diphenylhydantoic Acid 6802-95-5 D491660

1-(Diphenylmethyl)-4-[(1RS,3E)-4-phenyl-1-[(E)-2-phenylethenyl)-3-buten-1-yl]piperazine

1199751-98-8 D491775

Dipropofol 2416-95-7 D492140

N-[2-(Diphenylmethoxy)ethyl]-N,N',N'-trimethyl-ethylenediamine Dimaleate 2718-46-9 D492205

(3R,6R)-3,6-Diphenyl-2,5-piperazinedione 31485-02-6 D492280

α-[(Dimethylamino)methylene]-2,3,4,5-tetrafluoro-β-oxo-benzenepropanoic Acid Ethyl Ester

138998-47-7 D492410

Dipyridamole Tri(diethanolamine) 16908-47-7 D492645

Dipyridamole Tripiperidine 16982-40-4 D492650

2,2'-Dipyridylamine 1202-34-2 D492740

O,O'-Dipropanal Ganciclovir 86357-20-2 D492795

5-(N-(3-(2,3-Dihydroxypropoxy)-3-hydroxypropyl)acetamido) Iohexol D493373

5-(N-(2-(2,3-Dihydroxypropoxy)-3-hydroxypropyl)acetamido) Iohexol D493375

N1-(3-(2,3-Dihydroxypropoxy)-2-hydroxypropyl) Iohexol D493378

N1-(2-(2,3-Dihydroxypropoxy)-3-hydroxypropyl Iohexol D493380

1-(3-(N-(2,3-Dihydroxypropyl)acetamido) Iohexol D493383

3-(3-(N-(2,3-Dihydroxypropyl)acetamido) Iohexol D493385

3,3'-Disulfanediylbis[(2S)-2-methylpropanoic] Acid 65134-74-9 D493665

Di-2-thienylglycolic Acid 4746-63-8 D493915

(+)-O,O’-Di-p-toluoyl-D-tartaric Acid 32634-68-7 D494380

Docetaxal 125354-16-7 D494565

2,3-Dimethoxy-5-methyl-p-benzoquinone 605-94-7 D494713

4-(+)-(Dimethylamino)-3-methyl-2,2-diphenyl-butyronitrile (Isodidiavalo) >90% 6134-96-9 D495048

Dolutegravir SR Isomer 1309560-49-3 D528825

Domperidone N-Oxide 118435-03-3 D531110

Donepezil Benzyl Bromide (Donepezil Impurity) 844694-85-5 D531740

rac-(cis/trans) Donepezil N-Oxide 120013-84-5 D531760

Donepezil-4-hydroxy 197010-22-3 D531775

D-DOPA 5796-17-8 D533750

rac-cis Dorzolamide Hydrochloride 120279-37-0 D535115

ent-Dorzolamide 120279-95-0 D535125

rac-Dorzolamide 120280-13-9 D535145

Doxifluridine 3094-09-5. D556750

Doxybetasol 1879-77-2 D561000

Doxylamine 4-Pyridinyl Isomer 873407-01-3 D562020

Page 41: IMPURITY REFERENCE EP - LGC Ltd€¦ · (Anagrelide Impurity B) 1159977-03-3 A604740 2-Amino-5,6-dichloro-3(4H)-quinazoline Acetic Acid Hydrobromide (Anagrelide Impurity B) 1194434-39-3

41 20 Martin Ross Avenue North York, ON Canada, M3J 2K8

www.trc-canada.com [email protected] +1-416-665-9696

Chemical Name CAS Number Catalog Number

3,4-Dihydro-4-hydroxy-2-methyl-2H-1,1-dioxide-1,2-benzothiazine-3-carboxylic Acid Ethyl Ester

113913-36-3 D678975

17R-Drospirenone 90457-65-1 D689505

6α,7α-Drospirenone 889652-31-7 D689515

(S)-Duloxetine Succinamide 199191-66-7 D721015

(S)-Duloxetine Phthalamide 199191-67-8 D721020

17α-Dutasteride 1796930-46-5 D735010

3-Methyl-1-phenyl-2-pyrazolin-5-one(Edaravone)

89-25-8 E335000

Emtricitabine Carboxylic Acid 1238210-10-0 E525035

(R,S,S)-Enalapril Maleate 1356932-13-2 E555245

Enalapril Diketopiperazine 115729-52-7 E555270

Enalaprilat Dihydrate 84680-54-6 E555375

Enalaprilat 76420-72-9 E555405

Enrofloxacin 93106-60-6 E557800

cis-Entacapone 145195-63-7 E558490

1’-epi-Entecavir 1367369-78-5 E558920

3’-epi-Entecavir 1367369-77-4 E558925

4’-epi-Entecavir 1367369-80-9 E558930

7-Epi Clindamycin 16684-06-3 E582485

7-Epiclindamycin 2-Phosphate (>90%) 620181-05-7 E582505

16-Epi-deacetyl-fusidic Acid 5951-83-7 E583000

7-Epi 10-Desacetyl Paclitaxel 78454-17-8 E583500

2’-Epi-9,10-dihydroergotamine 5550-75-4 E584910

7-Epi Docetaxel 153381-68-1 E585300

4-Epi Doxycycline (>70%) 6543-77-7 E585900

6-Epi Doxycycline 3219-99-6 E585925

16-Epiestriol 547-81-9 E586500

17-Epiestriol 1228-72-4 E586510

1’-Epi Gemcitabine Hydrochloride 122111-05-1 E588510

Epi Lovastatin 79952-44-6 E588530

4-Epi Minocycline (>80%, contains unidentified salts) 43168-51-0 E588540

2’-Epi-Lamivudine 136846-20-3 E588545

11-Epihydrocortisone 566-35-8 E588570

7-Epi-10-oxo Docetaxel 162784-72-7 E588610

7-Epi Paclitaxel 105454-04-4 E588630

Δ9,11-Eplerenone 95716-70-4 E588765

7β-Eplerenone 209253-81-6 E588770

11-epi-Prednisolone 600-90-8 E588855

Page 42: IMPURITY REFERENCE EP - LGC Ltd€¦ · (Anagrelide Impurity B) 1159977-03-3 A604740 2-Amino-5,6-dichloro-3(4H)-quinazoline Acetic Acid Hydrobromide (Anagrelide Impurity B) 1194434-39-3

42 20 Martin Ross Avenue North York, ON Canada, M3J 2K8

www.trc-canada.com [email protected] +1-416-665-9696

Chemical Name CAS Number Catalog Number

9β,11β-Epoxy-17,21-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 981-34-0 E589175

9β,11β-Epoxy-17,21-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 21-Acetate

912-38-9 E589185

4-(2,3-Epoxypropoxy)carbazole 51997-51-4 E589250

(6α,9β,11β,16α)-9,11-Epoxy-6-fluoro-21-hydroxy-16,17-[(1-methylethylidene)bis (oxy)]pregna-1,4-diene-3,20-dione

68352-03-4 E589285

4-(2,3-Epoxypropoxy)phenylacetamide 29122-69-8 E589600

p-(2,3-Epoxypropoxy)benzyl Alcohol 4204-78-8 E589620

2’-(2,3-Epoxypropoxy)-3-phenylpropiophenone 22525-95-7 E589700

(Z)-Eprosartan 148674-39-9 E590095

Erdosteine Bis-N-(2-Oxo-3-tetrahydrothienyl) Impurity (Erdosteine EP21506) E596075

Erythromycin A Enol Ether 33396-29-1 E649970

Erythromycin A Oxime 13127-18-9 E650010

Erythromycylamine 26116-56-3 E653400

Estriol Methyl Ether 1474-53-9 E668660

N,N'-[1,2-Ethanediylbis[oxy[5-(2-methoxyphenoxy)[2,2'-bipyrimidine]-6,4-diyl]]]bis[4-(1,1-dimethylethyl)-benzenesulfonamide

1097263-60-9 E676300

N-Ethoxycarbonyl Norfloxacin 105440-01-5 E678275

N-[2-(2-Ethoxyphenoxy)ethyl]-(R)-Tamsulosin 918867-88-6 E678605

Ethyl (S)-1-Phenyl-1,2,3,4-tetrahydro-2-isoquinolinecarboxylate 180468-42-2 E679700

17-epi-Ethynyl Estradiol 4717-38-8 E685095

Ethyl 3-Amino-4-pyrazolecarboxylate 6994-25-8 E703100

3-Ethyl-2-methyl-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimidin-4-one(Risperidone Impurity)

70381-58-7 E817980

17α-Estradiol 57-91-0 E887995

17β-Estradiol 50-28-2 E888000

∆9(11)-Estradiol 791-69-5 E888030

Estrone 53-16-7 E889050

Ethanol Ring-opened Aztreonam E890393

5-Ethenyl-2-pyrrolidinone 7529-16-0 E890415

N-Ethoxycarbonyl-ciprofloxacin 93594-29-7 E890615

(+)-N-[1-(S)-Ethoxycarbonxyl-3-phenylpropyl]-L-alanine 82717-96-2 E891586

1-(3-Ethoxy-4-methoxy-phenyl)-2-methanesulfonylethylamine 253168-94-4 E891705

Ethoxy-5-fluoro-4(3H)-pyrimidinone 56177-80-1 E892040

N-[2-[(1S)-1-(3-Ethoxy-4-hydroxyphenyl)-2-(methylsulfonyl)ethyl]-2,3-dihydro-1,3-dioxo-1H-isoindol-4-yl]acetamide

1384441-38-6 E892255

8-Ethoxy Moxifloxacin Hydrochloride E892525

2-(2-Ethoxyphenoxy)ethyl Bromide 3259-03-08 E892663

4-Ethoxy-3-(4-pyridinyl)-3-buten-2-one 88349-61-5 E892795

2-(2-Ethoxyphenoxy)ethanamine 6781-17-5 E892870

Page 43: IMPURITY REFERENCE EP - LGC Ltd€¦ · (Anagrelide Impurity B) 1159977-03-3 A604740 2-Amino-5,6-dichloro-3(4H)-quinazoline Acetic Acid Hydrobromide (Anagrelide Impurity B) 1194434-39-3

43 20 Martin Ross Avenue North York, ON Canada, M3J 2K8

www.trc-canada.com [email protected] +1-416-665-9696

Chemical Name CAS Number Catalog Number

O-Ethyl Albuterol 754926-25-5 E897500

Ethyl-2-(6-amino-2,3-dichlorobenzylamino)acetate Hydrochloride 85325-12-8 E898190

1-Ethyl-3-bromoadamantane 878-61-5 E900280

O-Ethyl (5-Bromoquinoxalin-6-yl)carbamothioate(Brimonidine Impurity)

842138-75-4 E900560

7-Ethyl Camptothecin 78287-27-1 E900830

1H-1-Ethyl Candesartan Cilexetil 914613-35-7 E900870

2H-2-Ethyl Candesartan Cilexetil 914613-36-8 E900875

N1-Ethylcarbamoyl Cabergoline 126554-50-5 E900925

Ethyl 2-Cyclohexyl-2-hydroxyphenylacetate 31197-69-0 E908950

α-Ethyl-α-(1-demethylethyl)-Verapamil Hydrochloride 190850-49-8 E913100

[4-[2-[[(3-Ethyl-2,5-dihydro-4-methyl-2-oxo-1H-pyrrol-1-yl)carbonyl]amino]ethyl]phenyl]sulfonyl]carbamic Acid Ethyl Ester

318515-70-7 E916540

13-Ethyl-18,19-dinor-17α-pregn-4-en-20-yn-17-ol (~90%)(Levo Norgestrel Impurity)

32419-58-2 E916950

1-Ethyl-2,3-dioxopiperazine 59702-31-7 E917360

3,3'-(Ethylenediimino)di-1-propanol 25448-76-4 E917798

Ethylenediamine P-Toluenesulfonate 14034-59-4 E917858

13-Ethyl-3-ethynyl-18,19-dinor-17α-pregna-3,5-dien-20-yn-17-ol(Levo Norgestrel Impurity)

1337972-89-0 E917880

4-Ethyl-5-fluoropyrimidine 137234-88-9 E918001

13-Ethylgon-5(10)en-3,17-dione 4222-96-2 E918595

D-Ethyl Gonendione 21800-83-9 E918600

p-Ethylhydratropic Acid 3585-52-2 E918820

Ethyl 4-Hydroxy-2H-1,2-benzothiazine-3-carboxylate 1,1-Dioxide (Piroxicam Impurity H)

24683-21-4 E918850

13-Ethyl-17-hydroxy-18,19-dinor-17α-pregn-5(10)-en-20-yn-3-one(Levo Norgestrel Impurity)

19914-67-1 E918935

Ethyl 4-Hydroxy-2-methyl-2H-1,2-benzothiazine-3-carboxylate 1,1-Dioxide 24683-26-9 E918980

Ethyl 5-Methyl-6-oxo-5,6-dihydro- 4H-benzo[f]imidazo[1,5-a][1,4]diazepine-3-carboxylate

78756-03-3 E923525

5-Ethyl-3-[[(2R)-1-methyl-2-pyrrolidinyl]methyl]-1H-indole 209682-64-4 E924900

4-[2-[(3-Ethyl-4-methyl-2-oxo-3-pyrrolin-1-yl)carboxamido]ethyl]benzenesulfonamide

119018-29-0 E925045

Ethyl α-(p-Methoxyphenyl)-β-(dimethylamino)propionate 323176-93-8 E925055

N-Ethyl-N-methyl-3-vinylphenyl Carbamate 1346602-84-3 E925205

Ethyl 3-Oxo-4-aza-5α-androst-1-ene-17β-carboxylate 157307-36-3 E925345

2-Ethyl-2-phenylmalonamide 7206-76-0 E925455

5-Ethyl-5-phenyl-2-(1-phenylpropyl)dihydropyrimidine-4,6(1H,5H)-dione(Mixture of Diastereomers)

1189504-46-8 E925460

4-[2-(5-Ethyl-2-pyridinyl)ethoxy]benzenepropanoic Acid Ethyl Ester (Pioglitazone Impurity)

868754-42-1 E925585

5-[[4-[2-(5-Ethyl-2-pyridinyl)ethoxy]phenyl]-methylene]-2,4-thiazolidinedione (Pioglitazone Impurity)

144809-28-9 E925590

3-Ethyl-2,5-pyrazinediethanol 86917-74-0 E925605

Page 44: IMPURITY REFERENCE EP - LGC Ltd€¦ · (Anagrelide Impurity B) 1159977-03-3 A604740 2-Amino-5,6-dichloro-3(4H)-quinazoline Acetic Acid Hydrobromide (Anagrelide Impurity B) 1194434-39-3

44 20 Martin Ross Avenue North York, ON Canada, M3J 2K8

www.trc-canada.com [email protected] +1-416-665-9696

Chemical Name CAS Number Catalog Number

3-[2-[(5-Ethyl-2-pyridinyl)ethoxy]phenyl] Pioglitazone Impurity 952187-99-4 E925740

N-[Ethyl-(2-pyridyl-5-ethyl) Pioglitazone (Pioglitazone Impurity)

952188-00-0 E925750

Ethyl 2-(2-Oxopyrrolidin-1-yl)acetate (80%) 61516-73-2 E925885

3-Ethyl-6,7,8,9-tetrahydro-9-hydroxy-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one

849903-79-3 E926295

Ethyl Trazodone 1346599-35-6 E927100

7-Ethyltryptophol 41340-36-7 E931880

(17α)-3-Ethynyl-19-norpregna-3,5-dien-20-yn-17-ol 79727-03-0 E932270

Etiracetam Carboxylic Acid 67118-31-4 E932960

Everolimus (~90% pure) 159351-69-6 E945400

Everolimus Retroaldol Degradation Product 1708118-13-1 E945420

Ezetimibe Ketone 191330-56-0 E975065

Ezetimibe Tetrahydropyran Impurity 1296129-15-1 E975080

Famotidine Related Compound B 89268-62-2 F102260

Famotidine Acid Impurity 107880-74-0 F102280

Felodipine 3,5-Dimethyl Ester 91189-59-2 F232385

Fenbendazole Sulfoxide 53716-50-0 F246790

Fenofibric Acid 42017-89-0 F248650

Fenofibric Acid Ethyl Ester 42019-08-9 F248670

Fenofibric Acid Methyl Ester 42019-07-8 F248675

Fenofibric Acid 1,1-Dimethyl-2-(1-methylethoxy)-2-oxoethyl Ester 217636-48-1 F248680

meta-Fexofenadine 479035-75-1 F322480

Fexofenadinone 76811-98-8 F322520

Δ23-FK-506 104987-16-8 F370015

Flavanone 487-26-3 F371100

Flucloxacillin Penilloic Acid (Mixture of Diastereomers)

1276016-89-7 F419180

(Z)-Flunarizine 693765-11-6 F455205

Fluocinolone 807-38-5 F455795

Fluocinolone Acetonide-21-aldehyde 13242-30-3 F455810

Fluocinolone Acetonide-21-carboxylic Acid 106931-78-6 F455815

6-[(1E)-2-[3-(4-Fluorophenyl)-1-(1-methylethyl)-1H-indol-2-yl]ethenyl]-5,6-dihydro-4-hydroxy-2H-pyran-2-one

920275-10-1 F489645

Fumaric Acid Monoethyl Ester 2459-05-04 F500385

2'-Fluoroacetophenone 445-27-2 F587073

2-Fluorobiphenyl-4-carboxylic Acid 137045-30-8 F588760

2-Fluoro-4-desfluoro Bicalutamide 1159977-36-2 F590850

11-Fluoro Desloratadine 298220-99-2 F590900

(βR,δS)-8-Fluoro-5,6-dihydro-β,δ-dihydroxy-4-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-benzo[h]quinazoline-6-pentanoic Acid

1335110-44-5 F591135

Page 45: IMPURITY REFERENCE EP - LGC Ltd€¦ · (Anagrelide Impurity B) 1159977-03-3 A604740 2-Amino-5,6-dichloro-3(4H)-quinazoline Acetic Acid Hydrobromide (Anagrelide Impurity B) 1194434-39-3

45 20 Martin Ross Avenue North York, ON Canada, M3J 2K8

www.trc-canada.com [email protected] +1-416-665-9696

Chemical Name CAS Number Catalog Number

3-[2-[4-[4-Fluoro-2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]benzolyl]piperidin-1-yl]ethyl-2-methyl-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimidin-4-one

1329796-66-8 F591590

3-[2-[4-[(Z)-(4-Fluoro-2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl)phenyl](hydroxyimino)methyl]piperidin-1-yl]ethyl]-2-methyl-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimidin-4-one (Risperidone Impurity, Mixture of E/Z isomers)

1346606-24-3 F591595

9α-Fluoro-11β-hydroxy-16-β-methyl-3-oxoandrosta-1,4-diene-17(R)-spiro-2’-[4’-chloro-5’-ethylfuran-3’(2’H)-one

1486466-31-2 F591800

9-Fluoro-16α,17-(isopropylidenedioxy) Corticosterone 1524-86-3 F592050

8-Fluoro-6-methoxy Moxifloxacin Dihydrochloride F593300

4-Fluoro-α-(2-methyl-1-oxopropyl)-γ-oxo-N,β-diphenyl-benzenebutanamide 125971-96-2 F593700

1-Fluoronaphthalene 321-38-0 F593760

(5R)-3-[3-Fluoro-4-(4-morpholinyl)phenyl]-5-[[(methylsulfonyl)oxy]methyl]-2-oxazolidinone

174649-09-3 F594970

4-(4-Fluorophenyl)-1-methyl-1,2,3,6-tetrahydropyridine Hydrochloride 1012886-75-7 F595220

nor-Flurazepam 2886-65-9 F595240

3-Fluorophenyl Bicalutamide 1166228-30-3 F595335

N-[4-(4-Fluorophenyl)-5-formyl-6-(1-methylethyl)-2-pyrimidinyl]-N-methyl-methanesulfonamide

147118-37-4 F595365

3’-(2-Fluorophenyl) Ezetimibe 1798008-25-9 F595370

(4R,6S)-6-[(1E)-2-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-5-pyrimidinyl]ethenyl]-2,2-dimethyl-1,3-dioxane-4-acetic Acid 1,1-Dimethylethyl Ester

289042-12-2 F595400

5-(4-Fluorophenyl)-2-(1-methylethyl)-1-(3-oxopropyl)-N,4-diphenyl-1H-pyrrole-3-carboxamide

110862-46-9 F595480

6-Fluoro-3-(4-piperidinyl)-1,2-benzisoxazole Hydrochloride 84163-13-3 F595580

9α-Fluoroprednisolone 17-Valerate 2802-10-0 F595615

3-[(4-Fluorophenyl)sulfonyl]-2-hydroxy-2-methylpropanoic Acid 151262-57-6 F595620

5-Fluoro Risperidone 1199589-74-6 F595925

4-(4-Fluorophenyl)-1,2,3,6-tetrahydro-1-methylpyridine 69675-10-1 F595978

5-Fluoro Uracil 51-21-8 F596000

Fluoxetine Succinamic Acid 1026723-45-4 F597110

Fluphenazine Sulfoxide

(Fluphenazine Decanoate EP Impurity A) 1674-76-6 F598415

Fluphenazine Octanoate 97671-70-0 F598425

Fluphenazine Decanoate 61555-18-8 F598435

Flurandrenolone Acetate 2802-11-01 F598655

o-Flutamide 151262-93-0 F598855

4-(2-hydroxyethyl)piperazin-1-yl)propoxy)-Fluphenazine F599040

Fluticasone Acetate 80474-24-4 F599450

Fluticasone 17β-Carbonylsulfenic Acid 17-Propionate 948566-12-9 F599480

Fluticasone 17β-Carboxylic Acid Propionate 65429-42-7 F599495

Page 46: IMPURITY REFERENCE EP - LGC Ltd€¦ · (Anagrelide Impurity B) 1159977-03-3 A604740 2-Amino-5,6-dichloro-3(4H)-quinazoline Acetic Acid Hydrobromide (Anagrelide Impurity B) 1194434-39-3

46 20 Martin Ross Avenue North York, ON Canada, M3J 2K8

www.trc-canada.com [email protected] +1-416-665-9696

Chemical Name CAS Number Catalog Number

Fluticasone Dimer Impurity (~90%) 220589-37-7 F599520

Fluvastatin N-Ethyl Sodium Salt (Fluvastatin Impurity) 93936-64-2 F601240

(3R,5S)-Fluvastatin tert-Butyl Ester 194934-96-8 F601270

(Z)-Fluvoxamine 89035-92-7 F603505

Fluvoxketone 61718-80-7 F603700

3-(Formylamino)-1H-pyrazole-4-carboxamide 22407-20-1 F696750

3-(Formylamino)-1H-pyrazole-4-carboxylic Acid Ethyl Ester 31055-19-3 F696760

2-Formyl-cefpodoxime Proxetil 96680-30-7 F698700

N-Formyl Cefotaxime 66403-32-5 F698705

N-Formyl Desloratadine 117810-61-4 F700300

N-Formyl-L-leucine (3S,4S,6S)-3-Hexyltetrahydro-2-oxo-6-undecyl-2H-pyran-4-yl Ester

130676-65-2 F700565

N-Formyl-L-leucine (3S,4R,6S)-3-Hexyltetrahydro-2-oxo-6-undecyl-2H-pyran-4-yl Ester

130793-27-0 F700570

N-Formyl Leurosine 54022-49-0 F700650

5-Formyl-2-methoxy-benzenesulfonamide 105764-07-6 F700730

rac 2-(4-Formylphenyl)propionic Acid (Ibuprofen Impurity K)

43153-07-7 F700900

5-Formyl-α,α,α’,α’-tetramethyl-1,3-benzenediacetonitrile 120511-89-9 F701010

N-Formyl Norfloxacin 70459-04-0 F701015

5-Formyltetrahydropteroic Acid 4349-43-3 F701080

N-Formyl Thyroxine 671235-41-9 F701300

N-Formyl Valacyclovir 847670-62-6 F701570

Fosinoprilat 95399-71-6 F727815

7β-Fulvestrant 407577-53-1 F862495

Fulvestrant 9-Sulfone 98008-06-1 F862525

2-Furanyl-1-piperazinylmethanone 40172-95-0 F864040

4H-Furo[2,3-c]pyranyl Mupirocin Sodium Impurity 116182-43-5 F864850

Gabapentin Related Compound A 64744-50-9 G117275

Gabapentin Related Compound B 133481-09-1 G117278

Gabapentin Related Compound D 1076198-17-8 G117285

Gabapentin Related Compound E 67950-95-2 G117290

Ganciclovir Mono-O-propionate 194159-18-7 G235020

cis-Glimepiride 684286-46-2 G410145

meta-Glimepiride Impurity. 791104-62-6 G410160

exo-Granisetron 1364914-39-5 G780010

2-[[(Guanidino)(imino)methyl]sulfanyl]ethanesulfonic Acid 1391053-66-9 G835250

Guanine 73-40-5 G836000

O-[(Guanin-9-yl)methyl] Acyclovir 166762-90-9 G836410

Page 47: IMPURITY REFERENCE EP - LGC Ltd€¦ · (Anagrelide Impurity B) 1159977-03-3 A604740 2-Amino-5,6-dichloro-3(4H)-quinazoline Acetic Acid Hydrobromide (Anagrelide Impurity B) 1194434-39-3

47 20 Martin Ross Avenue North York, ON Canada, M3J 2K8

www.trc-canada.com [email protected] +1-416-665-9696

Chemical Name CAS Number Catalog Number

Guaninyl Valacyclovir G836500

Guanylmelamine Hydrochloride 2959-04-08 G844250

Heptobarbital 76-94-8 H281165

Hesperidine 520-26-3 H281185

Hexametazidine 1257-19-8 H291150

Hexahydro-1-[(4-methylphenyl)sulfonyl]-1H-1,4-diazepine 872103-28-1 H293795

(αS,3aS,4S,6S,7aR)-Hexahydro-3a,8,8-trimethyl-α-(2-methylpropyl)-4,6-Methano-1,3,2-benzodioxaborole-2-methanamine Hydrochloride

945606-99-5 H294435

(3aS,4R,5S,6aR)-Hexahydro-5-hydroxy-4-(hydroxymethyl)-2H-cyclopenta[b]furan-2-one

76704-05-7 H294795

(S)-3-Hexyl-5,6-dihydro-6-undecyl-2H-pyran-2-one 130676-64-1 H295800

(3S,4S)-3-Hexyl-4-[(2R)-2-hydroxytridecyl]-2-oxetanone 104872-06-2 H296530

(R)-2,3-Dihydro-2-phenyl-4H-1-benzopyran-4-one 27439-12-9 H447850

Di-Norbudesonide (Mixture of Diastereomers)

1040085-98-0 H589650

DL-Homophenylalanine 1012-05-1 H591310

Hydrocortisone 21-Aldehyde Hydrate 906337-64-2 H714580

Hydrocortisone (Cortisol)

50-23-7 H714615

Hydrocortisone 11,21-Diacetate 81968-66-3 H714618

Hydrocortisone 21-Acetate 1950-03-03 H714620

Hydrocortisone 17-Acetate 16463-74-4 H714695

β-Hydrocodol 795-38-0 H714810

(R)-Hydroperoxy Des(boric Acid) Bortezomib 886979-78-8 H715415

4'-Hydroxyacetophenone 99-93-4 H739980

4’-Hydroxyacetophenone Oxime 34523-34-7 H741050

2-Hydroxyalmotriptan 1309457-19-9 H749985

6β-Hydroxy Norethindrone 51724-44-8 H750025

6β-Hydroxy Norethindrone Acetate 6856-27-5 H750035

Hydroxy Adapalene 1346599-76-5 H750045

6-Hydroxy Alosetron 128486-89-5 H761450

7-Hydroxy Alosetron 863485-44-3 H761460

Hydroxyamino Lamotrigine H784335

3-Hydroxyagomelatine 166526-99-4 H798280

Hydroxyatenolol 68373-10-4 H802480

4’-Hydroxy Atomoxetine 435293-66-6 H802500

7-Hydroxy Chlorpromazine Hydrochloride 51938-11-5 H825065

4-(2-Hydroxyethyl)-1H-pyrrole-3-carboxylic Acid 404839-11-8 H825350

4-(Hydroxymethyl)benzoic Acid 3006-96-0 H825540

3-Hydroxy-4-methyl-2(5H)-thiophenone 34876-35-2 H825545

Page 48: IMPURITY REFERENCE EP - LGC Ltd€¦ · (Anagrelide Impurity B) 1159977-03-3 A604740 2-Amino-5,6-dichloro-3(4H)-quinazoline Acetic Acid Hydrobromide (Anagrelide Impurity B) 1194434-39-3

48 20 Martin Ross Avenue North York, ON Canada, M3J 2K8

www.trc-canada.com [email protected] +1-416-665-9696

Chemical Name CAS Number Catalog Number

(19E/Z)-seco-[4-O-(2-Hydroxyethyl)] Rapamycin 1062122-63-7 H825605

(3S,6S,7S,9S,12S)-7-Hydroxy-N1,N14-dimethyl-3,12-bis(1-methylethyl)-N1,N14-bis[[2-(1-methylethyl)-4-thiazolyl]methyl]-4,11-dioxo-6,9-bis(phenylmethyl)-2,5,10,13-tetraazatetradecanediamide

869368-48-9 H825640

N-Hydroxy Lenalidomide H825665

6α-Hydroxy Levonorgestrel 87585-03-3 H825695

10-Hydroxy Amitriptyline Oxalate 1246833-15-7 H828100

2-Hydroxy Atorvastatin Lactone 163217-74-1 H828955

3-Hydroxybenzaldehyde 100-83-4 H828965

4-Hydroxybenzaldehyde 123-08-0 H828970

4-Hydroxybenzyl Alcohol 623-05-2 H828995

2-Hydroxybenzimidazole 615-16-7 H829000

Hydroxy Brimonidine Trifluoroacetic Acid Salt 1391054-10-6 H830000

Hydroxy Bosentan 253688-60-7 H830270

6α-Hydroxy Budesonide 577777-51-6 H830345

6β-Hydroxy Budesonide 88411-77-2 H830350

10-Hydroxy Camptothecin 19685-09-7 H875000

17α-Hydroxy-21-chloro-9β,11β-epoxy-16α-methylpregna-1,4-diene-3,20-dione

83881-08-7 H915450

3-Hydroxy Citalopram 411221-53-9 H918350

3-Hydroxy Citalopram Oxalate 1332724-03-4 H918355

19-Hydroxycortisol 154032-37-8 H918440

6β-Hydroxy Cortisol 53-35-0 H922300

17α-Hydroxy-11-deoxycorticosterone-21-acetate 640-87-9 H934800

(R)-Hydroxy Des(boric Acid) Bortezomib 289472-78-2 H935900

(S)-Hydroxy Des(boric Acid) Bortezomib 289472-81-7 H935905

Hydroxy Desmethyl Bosentan 253688-62-9 H938000

8-Hydroxy-9,10-dihydroergotamine H939495

8-Hydroxy Entecavir H939670

6β-Hydroxylevonorgestrel 55555-97-0 H939820

Hydroxy Melphalan (>90%) 61733-01-5 H939850

1-Hydroxy-3,4-dihydroquinolin-2(1H)-one 771-19-7 H941260

11-Hydroxy Dihydro Loratadine 133284-74-9 H941370

11-Hydroxy-N-methyl Dihydro Loratadine 38089-93-9 H941375

8-Hydroxy-3,4-dihydro-2(1H)-quinolinone 52749-50-5 H941405

6-Hydroxy-3,4-dihydro-1H-quinoline-2-one 54197-66-9 H941423

(1R,3S,5S)-3-(2-Hydroxy-2,2-di(thiophen-2-yl)acetoxy)-8,8-dimethyl-8-azabicyclo[3.2.1]oct-6-en-8-ium Bromide

136310-95-7 H941715

6-Hydroxy-L-DOPA 27244-64-0 H941725

Page 49: IMPURITY REFERENCE EP - LGC Ltd€¦ · (Anagrelide Impurity B) 1159977-03-3 A604740 2-Amino-5,6-dichloro-3(4H)-quinazoline Acetic Acid Hydrobromide (Anagrelide Impurity B) 1194434-39-3

49 20 Martin Ross Avenue North York, ON Canada, M3J 2K8

www.trc-canada.com [email protected] +1-416-665-9696

Chemical Name CAS Number Catalog Number

Hydroxy Donepezil (Mixture of Diastereomers)

197010-20-1 H941740

N-(2-((2-(4-(2-(2-Hydroxyethoxy)ethyl)piperazine-1-carbonyl)phenyl)thio)phenyl)acetamide

1371638-10-6 H941840

6α-Hydroxy 17β-Estradiol 1229-24-9 H941845

16α-Hydroxy Estrone 566-76-7 H941900

1-[2-(2-Hydroxyethoxy)ethyl]piperazine 13349-82-1 H941910

3-(2-Hydroxyethyl)benzoic Acid 320730-08-3 H941998

6α-Hydroxy Ethynyl Estradiol 27521-34-2 H942005

6β-Hydroxy Ethynyl Estradiol 56324-28-8 H942010

9-(2-Hydroxyethyl)guanine 23169-33-7 H942035

2,2',2'',2'''-[[4-[(2-Hydroxyethyl)amino]-8-(1-piperidinyl)pyrimido[5,4-d]pyrimidine-2,6-diyl]dinitrilo]tetrakisethanol (Dipyridamole Impurity)

60286-30-8 H942065

4-(2-Hydroxyethyl)-1,3-dihydro-2H-indolin-2-one 139122-19-3 H942090

N7-[(2-Hydroxyethoxy)methyl)guanine 91702-61-3 H942195

1-Hydroxy Ibuprofen (Ibuprofen Impurity L)(Mixture of Diastereomers)

53949-53-4 H942858

rac α-Hydroxy Ibuprofen 60057-62-7 H942863

4-O-[2-Hydroxy-2-[4-hydroxy-3-(hydroxymethyl)phenyl]ethyl] Salmeterol 1391052-04-2 H943080

3-Hydroxyimino Ropinirole H943340

4-(2-Hydroxy-3-isopropylaminopropoxy)benzoic Acid 72570-70-8 H943575

4-Hydroxyisophthalic Acid 636-46-4 H943580

(6R,7R)-7-(4-Hydroxyisoxazole-3-carboxamido)-8-oxo-3-vinyl-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid

1356842-10-8 H943595

(S)-2-Hydroxy-3-methoxy-3,3-diphenylpropionic Acid 178306-52-0 H946110

(R)-2-Hydroxy-3-methoxy-3,3-diphenylpropanoic Acid 178306-49-5 H946113

N-2-Hydroxy-3-[[2-(methoxyphenoxy)ethyl]amine Carvedilol 1198090-73-1 H946145

(S)-α-Hydroxy-β-methoxy-β-phenyl-benzenepropanoic Acid Methyl Ester 177036-78-1 H946295

3-[2-Hydroxy-3-[4-(2-methoxyethyl)phenoxy]propoxy]-1-isopropylamino-2-propanol (Mixture of Diasteromers) (Metoprolol Impurity J)

163685-37-8 H946315

6β-Hydroxymethylandrosta-1,4-diene-3,17-dione 121021-51-0 H946395

5-[4’-Hydroxymethyl-(1,1’-biphenyl)-2-yl]-2-triphenylmethyltetrazole 154709-18-9 H946465

2-[4-[(2RS)-2-Hydroxy-3-[(1-methylethyl)amino]propoxy]phenyl]acetonitrile; (Atenolol Impurity H)

29277-73-4 H946505

4-[2-Hydroxy-3-[(1-methylethyl)amino]propoxy]benzaldehyde 29122-74-5 H946735

7β-Hydroxymethyl Drospirenone H946850

4-(1-Hydroxy-1-methylethyl)-2-propyl-1H-imidazole-5-carboxylic Acid Ethyl Ester

144689-93-0 H946900

25-Hydroxylumisterol 61585-29-3 H947465

10α-Hydroxy Nicergoline 57935-66-7 H947590

(αR)-3-Hydroxy-α-[[methyl(phenylmethyl)amino]methyl]-benzenemethanol 1367567-95-0 H947740

Page 50: IMPURITY REFERENCE EP - LGC Ltd€¦ · (Anagrelide Impurity B) 1159977-03-3 A604740 2-Amino-5,6-dichloro-3(4H)-quinazoline Acetic Acid Hydrobromide (Anagrelide Impurity B) 1194434-39-3

50 20 Martin Ross Avenue North York, ON Canada, M3J 2K8

www.trc-canada.com [email protected] +1-416-665-9696

Chemical Name CAS Number Catalog Number

2-Hydroxymethyl Loratadine 609806-39-5 H947745

5-Hydroxy-1-methyl-4-nitroimidazole Sodium Salt (>90%) 35681-68-6 H947755

5-Hydroxy-N-methylprotriptyline 18029-54-4 H948035

3-Hydroxy-4-morpholino-1,2,5-thiazole 30165-97-0 H948475

8-Hydroxy Moxifloxacin Hydrobromide 1292904-74-5 H948485

8-Hydroxy Moxifloxacin Hydrochloride Salt H948488

10β-Hydroxy Naloxone H948645

10α-Hydroxy Naloxone H948660

21-Hydroxy Deschloromometasone Furoate (Impurity)Mometasone Furoate Impurity H

148596-90-1 H948730

α-Hydroxy Olopatadine Hydrochloride 1331668-21-3 H948770

4,4'-[(2-Hydroxy-1,3-propanediyl)bis(oxy)]bis-benzeneacetamide (Atenolol Impurity E)

141650-31-9 H948995

4-Hydroxyphenylacetamide 17194-82-0 H949045

4-Hydroxy-α1-[[[6-(2-phenylethoxy)hexyl]amino]methyl]-1,3-benzenedimethanol

94749-02-7 H949145

4-Hydroxy-α1-[[[6-(3-phenylpropoxy)hexyl]amino]methyl]-1,3-benzenedimethanol

94749-11-8 H949165

4-Hydroxy-D-(-)-2-phenylglycine 22818-40-2 H949250

3-(o-Hydroxyphenyl)-5-phenyl-2-cyclohexen-1-one 15156-56-6 H949435

N-(2-Hydroxyethyl)phthalimide 3891-07-04 H949490

2’-Hydroxy-3-phenylpropiophenone 3516-95-8 H949600

N-Hydroxyphenylglycyl Cefadroxil 147103-95-5 H949665

2-Hydroxy-3-phenylpyrazine 2882-18-0 H950200

N,N’-[(2-Hydroxypropane-1,3-diyl)bis[oxy(3-acetyl-1,4-phenylene)]]dibutanamide (Acebutolol Impurity)

1329613-31-1 H950830

p-Hydroxy-(D)-phenylglycyl Amoxicillin 188112-75-6 H950855

25-Hydroxyprovitamin D3 22145-68-2 H950940

3-(4-Hydroxyphenyl)-2(1H)-pyrazinone 126247-63-0 H951260

3α-Hydroxy Pravastatin Sodium Salt 81093-43-8 H952310

17α-Hydroxy Progesterone 68-96-2 H952330

6β-Hydroxy Prednisolone 16355-29-6 H952350

20(S)-Hydroxy Prednisolone 2299-46-9 H952360

1,1’-[Hydroxypropane-1,3-diylbis(oxy-2,1-phenylene)]bis(3-phenylpropan-1-one)

1329643-40-4 H952500

N-(3-Hydroxypropyl)ethylenediamine 56344-32-2 H952728

7-Hydroxyquinoline-(1H)-2-one 70500-72-0 H953255

rac 9-Hydroxy Risperidone

**See P141000** 144598-75-4 H953350

Hydroxy Ritonavir 176655-56-4 H953390

9a-Hydroxy Ramipril Diketopiperazine 1309040-96-7 H953715

Page 51: IMPURITY REFERENCE EP - LGC Ltd€¦ · (Anagrelide Impurity B) 1159977-03-3 A604740 2-Amino-5,6-dichloro-3(4H)-quinazoline Acetic Acid Hydrobromide (Anagrelide Impurity B) 1194434-39-3

51 20 Martin Ross Avenue North York, ON Canada, M3J 2K8

www.trc-canada.com [email protected] +1-416-665-9696

Chemical Name CAS Number Catalog Number

4-Hydroxy-isophthalic Acid Dimethyl Ester 5985-24-0 H953760

N-(4-(2-Hydroxy-3-(isopropylamino)propoxy)phenyl)butyramide Hydrochloride 1432053-72-9 H957145

(S)-1-β-Hydroxy-1-(2-thienyl)-3-methylaminopropane 116539-55-0 H961815

β-Hydroxy Thyroxine 107849-54-7 H963600

N-(3-Hydroxytricyclo[3.3.1.13,7]dec-1-yl)glycyl-L-prolinamide 565453-39-6 H971380

5-Hydroxy L-Tryptophan 4350-09-08 H975710

rac-Ibuprofen Amide 59512-17-3 I140035

Ibuprofen Dimer 1391054-15-1 I140040

Icomethasone 4647-20-5 I164100

Icomethasone 21-Acetate 24916-91-4 I164105

Icomethasone 21-Mesylate 352315-75-4 I164110

Iloperidone N-Oxide (cis/trans Mixture) 1375651-09-4 I267205

Imatinib (Piperazine)-4-oxide 571186-91-9 I268000

Imidazole 288-32-4 I350200

Iminodibenzyl 5-Carbonyl Chloride 33948-19-5 I408100

Iminostilbene 256-96-2 I445000

Iminostilbene N-Carbonyl Chloride 33948-22-0 I445010

Indomethacin 53-86-1 I641000

Indomethacin Ethyl Ester 16401-99-3 I641030

17-Iodo-androsta-5,16-diene-3β-ol 32138-69-5 I686770

7-(4-Iodobutoxy)-3,4-dihydroquinolin-2-one 952308-47-3 I694200

6-Iodo Diosmin 1431536-92-3 I705850

8-anti-Ipratropium Bromide 58073-59-9 I740505

Isoacetovanillone 6100-74-9 I780000

Isoanastrozole 120511-92-4 I780025

Isobarbituric Acid 496-76-4 I780030

4'-Isobutylacetophenone 38861-78-8 I780065

m-Isobutyl Ibuprofen 66622-47-7 I780080

3-(4-Isobutylphenyl)propanoic Acid 65322-85-2 I780335

Isobutyl 2-(2-Nitrobenzylidene)acetoacetate 61312-59-2 I780635

4-Isobutyl-2-pyrrolidinone (pregabalin lactam impurity) 61312-87-6 I786500

Iso Cephalomannine 173101-54-7 I789500

Isoconazole Nitrate 24168-96-5 I798250

Iso Desloratadine 183198-49-4 I814995

Iso Fluconazole 89429-59-4 I816400

Iso Furosemide 4818-59-1 I818500

Iso Ganciclovir 86357-09-7 I818750

Page 52: IMPURITY REFERENCE EP - LGC Ltd€¦ · (Anagrelide Impurity B) 1159977-03-3 A604740 2-Amino-5,6-dichloro-3(4H)-quinazoline Acetic Acid Hydrobromide (Anagrelide Impurity B) 1194434-39-3

52 20 Martin Ross Avenue North York, ON Canada, M3J 2K8

www.trc-canada.com [email protected] +1-416-665-9696

Chemical Name CAS Number Catalog Number

Isorhoifolin 552-57-8 I819700

Iso Letrozole 112809-52-6 I820300

Iso Loratadine 170727-59-0 I821050

(5S)-Isomethadone 561-10-4 I821273

Isometronidazole 705-19-1 I821340

Isopilocarpic Acid Sodium Salt 101769-87-3 I821960

Isopilocarpine Hydrochloride 28958-85-2 I821970

Isopropyl DL-Mandelate 4118-51-8 I822225

Iso Promethazine Hydrochloride 5568-90-1 I822500

2-Isopropenyl-6-isopropylphenol 74926-89-9 I822850

4-[(2-Isopropoxyethoxy)methyl]phenol 177034-57-0 I823300

1-Isopropylamino-3-(p-tolyloxy)-2-propanol 5790-46-5 I823995

3-Isopropylamino-1,2-propanediol 6452-57-9 I824055

O-Isopropyl Chlorthalidone I824365

trans-4-Isopropylcyclohexanecarboxylic Acid 7077-05-06 I824400

1-Isopropyl Etodolac 849630-65-5 I824490

8-Isopropyl Etodolac 57917-63-2 I824505

1-Isopropyl-3-(4-fluorophenyl)indole-2-carboxaldehyde 101125-34-2 I824530

Isopropyl 4-Hydroxy-2H-1,2-benzothiazine-3-carboxylate 1,1-Dioxide (Piroxicam Impurity I)

76508-35-5 I824575

Isopropyl 4-Hydroxy-2-methyl-2H-1,2-benzothiazine-3-carboxylate 1,1-Dioxide (Piroxicam Impurity L)

118854-48-1 I824600

Isopropyl 2-Isopropylphenyl Ether 14366-59-7 I872100

Isopropyl Itraconazole 89848-49-7 I872150

N-Isopropyl Noratropine 22235-81-0 I872680

N-Isopropylnortropine Methobromide (Impurity) 58005-18-8 I872685

2-Isopropylphenol 88-69-7 I872700

3-Isopropylphenol 618-45-1 I872705

4-Isopropylphenol 99-89-8 I872710

rac 2-Isopropyl Pentanoic Acid 62391-99-5 I872870

2-Isopropyl-6-propylphenol 74663-48-2 I872895

Iso Rizatriptan 208941-96-2 I895500

Isotachysterol3, 90% 22350-43-2 I902460

Isoxepac 55453-87-7 I917700

rac-Isotimolol 59697-06-2 I918005

trans-Itraconazole 252964-65-1 I937505

Itraconazole Didioxolonyl Impurity I937515

Ivabradine N-oxide I940520

Page 53: IMPURITY REFERENCE EP - LGC Ltd€¦ · (Anagrelide Impurity B) 1159977-03-3 A604740 2-Amino-5,6-dichloro-3(4H)-quinazoline Acetic Acid Hydrobromide (Anagrelide Impurity B) 1194434-39-3

53 20 Martin Ross Avenue North York, ON Canada, M3J 2K8

www.trc-canada.com [email protected] +1-416-665-9696

Chemical Name CAS Number Catalog Number

Keto Bisoprolol Hydrochloride 1346603-26-6 K175150

11-Keto Budesonide (Mixture of Diastereomers)

216453-74-6 K175250

rac-trans-Ketoconazole 83374-59-8 K186010

6-Keto Cyproterone Acetate 17184-05-3 K187650

10-Keto Dextromethorphan 57969-05-8 K187800

6-Keto 17β-Estradiol 571-92-6 K188740

6-Keto Ethynyl Estradiol 38002-18-5 K188770

rac 5-Keto Fluvastatin 1160169-39-0 K188905

3-Keto Fusidic Acid 4680-37-9 K188980

11-Keto Fusidic Acid 16711-91-4 K188990

1-Keto Ketorolac 113502-52-6 K195300

4-Keto 13-cis-Retinoic Acid 71748-58-8 K204970

rac Ketorolac 6-Benzoyl Isomer 1026936-07-1 K235620

rac Ketorolac 7-Benzoyl Isomer 1391052-68-8 K235625

rac Ketoroloc Tris Amide Impurity 167105-80-8 K235640

Lamivudine (R)-Sulfoxide 160552-54-5 L172475

Lamivudine Acid 173829-09-9 L172490

ent-Lamivudine 134680-32-3 L172505

Lamivudine S-Oxide 1235712-40-9 L172530

(2R-cis)-1-[2-(Hydroxymethyl)-1,3-oxathiolan-5-yl]-2,4(1H,3H)-pyrimidinedione

145986-07-8 L172535

Lansoprazole Sulfide 103577-40-8 L175020

Lansoprazole Sulfone 131926-99-3 L175026

Lansoprazole N-Oxide 213476-12-1 L175035

(15S)-Latanoprost 145773-22-4 L177285

trans-Latanoprost 913258-34-1 L177300

Latanoprost Acid 41639-83-2 L177310

Latanoprost Tris(triethylsilyl) Ether 477884-78-9 L177390

Leflunomide EP Impurity F 1403564-06-6 L322755

Leflunomide EP Impurity G 724429-16-7 L322760

Leflunomide 3-Isomer 61643-23-0 L322765

(6-L-Leucine)-Leuprolide Trifluoroacetic Acid Salt L330595

(D-Ser4)-Leuprolide Trifluoroacetic Acid Salt L330605

(D-His2)-Leuprolide Trifluoroacetic Acid Salt 112642-11-2 L330610

(D-Tyr5)-Leuprolide Trifluoroacetic Acid Salt L330615

(R)-Levetiracetam 103765-01-1 L331505

Levofloxacin Ethyl Ester 177472-30-9 L360020

Levofloxacin N-oxide 117678-38-3 L360040

Page 54: IMPURITY REFERENCE EP - LGC Ltd€¦ · (Anagrelide Impurity B) 1159977-03-3 A604740 2-Amino-5,6-dichloro-3(4H)-quinazoline Acetic Acid Hydrobromide (Anagrelide Impurity B) 1194434-39-3

54 20 Martin Ross Avenue North York, ON Canada, M3J 2K8

www.trc-canada.com [email protected] +1-416-665-9696

Chemical Name CAS Number Catalog Number

Levofloxacin Carboxylic Acid (Levofloxacin Difluoro Impurity) 100986-89-8 L360250

Lidocaine N-Oxide 2903-45-9 L397815

Linagliptin Methyldimer (~90%) 1418133-47-7 L465910

Linagliptin Acetamide 1803079-49-3 L465920

Linarine 480-36-4 L466050

Lincomycin 2-Phosphate 27480-30-4 L466205

Lincomycin 154-21-2 L466230

Lisinopril (S,S,R)-Diketopiperazine (~90%) 219677-82-4 L468975

Lisinopril Cyclohexyl Analogue 1132650-67-9 L469000

Lopinavir EP-T Impurity 1797024-56-6 L469495

(2S,4R,5S)-Lopinavir 1798014-18-2 L469520

(2R,4S,5S)-Lopinavir 1217628-64-2 L469525

Lopinavir D-Valine Diastereomer 1623021-24-8 L469545

Loratadine Impurity F 125743-80-8 L469580

Lorazepam 846-49-1 L469850

Losartan Carboxaldehyde 114798-36-6 L470505

Losartan Isomer Impurity, Potassium Salt 860644-28-6 L470525

Losartan Trityl Ether 1006062-28-7 L470530

Losartan Isopropyl Ether 1332713-64-0 L470535

N1-Losartanyl-losartan (Losartan Impurity) 230971-71-8 L470600

N2-Losartanyl-losartan (Losartan Impurity) 230971-72-9 L470605

Loteprednol Etabonate Ethyl Ester 182069-19-8 L471405

Lovastatin 75330-75-5 L472225

Lovastatin Dimer 149756-62-7 L472245

Lovastatin Hydroxy Acid, Sodium Salt 75225-50-2 L472250

Lumisterol 3 (~90%) 5226-01-07 L474820

LY 88074 177744-96-6 L486900

(R)-(-)-Mandelic Acid 611-71-2 M162530

(S)-(+)-Mandelic Acid 17199-29-0 M162535

(3S)-3-(2-Methylpropyl)-pentanedioic Acid 1-Methyl Ester 181289-25-8 M199650

Medroxy Progesterone 520-85-4 M203550

Medroxy Progesterone 17-Acetate 71-58-9 M203560

6-epi-Medroxy Progesterone 17-Acetate 2242-65-1 M203570

Melphalan Mono-chloroethyl 573704-41-3 M216940

Metamelfalan 1088-80-8 M216945

(S)-(+)-Mepivacaine Hydrochloride 34333-71-6 M225075

2-Mercaptobenzimidazole 583-39-1 M225190

Page 55: IMPURITY REFERENCE EP - LGC Ltd€¦ · (Anagrelide Impurity B) 1159977-03-3 A604740 2-Amino-5,6-dichloro-3(4H)-quinazoline Acetic Acid Hydrobromide (Anagrelide Impurity B) 1194434-39-3

55 20 Martin Ross Avenue North York, ON Canada, M3J 2K8

www.trc-canada.com [email protected] +1-416-665-9696

Chemical Name CAS Number Catalog Number

Mesoridazine 5588-33-0 M225760

Meta Fluoxetine Hydrochloride 79088-29-2 M225820

3-Methoxy Androsta-3,5-dien-17-one 57144-06-6 M226040

3-[4-(2-Methoxyethyl)phenoxy]-1,2-propanediol 62572-90-1 M226140

4-Methanesulfonyloxybutanol 42729-95-3 M226320

3-Mercapto-2-methylpropanoic Acid 26473-47-2 M253950

Methacycline 914-00-1 M258788

N-((4-(5-Methyl-3-(3-(N-propionylsulfamoyl)phenyl)isoxazol-4-yl)phenyl)sulfonyl)propionamide

1708094-99-8 M258920

3-(5-Methyl-4-phenylisoxazol-3-yl)benzene-1-sulfonyl Chloride 1373038-57-3 M258925

3-(5-Methyl-4-phenylisoxazol-3-yl)benzenesulfonamide 1373038-56-2 M258930

3-(5-Methyl-4-(4-sulfamoylphenyl)isoxazol-3-yl)benzenesulfonamide 1373038-59-5 M258935

Methotrexate Dimethyl Ester 34378-65-9 M260685

Methotrexate α-Methyl Ester 66147-29-3 M260700

Methotrexate γ-Methyl Ester 67022-39-3 M260705

6'-Methoxy-2'-acetonaphthone (Naproxen Impurity L) 3900-45-6 M260805

2-Methoxy-4-amino-5-ethylsulfonylbenzoic Acid 71675-87-1 M260880

1-Methoxy Amiodarone 1087223-70-8 M260915

3'-Methoxyacetophenone 586-37-8 M261115

10-Methoxy Carbamazepine 28721-09-7 M261260

N-(Methoxycarbonyl)-L-tert-leucine 162537-11-3 M261295

PMA 64-13-1 M261405

Deschloro Acenapine 1847487-56-2 M261565

(S)-1-(3-Methoxyphenyl)-N,N-dimethylethanamine 889443-69-0 M262195

10α-Methoxy-1-methyl-9,10-dihydrolysergol 35155-28-3 M262295

N-(4-Methoxy-3,5-dimethyl-2-pyridinyl)methyl Omeprazole Sulfone 1346599-74-3 M262320

8(9)-Methoxy-1,3-dimethyl-12-thioxopyrido[1’,2’:3,4]imidazo[1,2-a]benzimidazol-2-(12H)-one (Mixture of Regioisomers)

M262560

4-(2-Methoxyethyl)phenol 56718-71-9 M262575

(αZ)-α-(Methoxyimino)-N-[(5aR,6R)-1,4,5a,6-tetrahydro-1,7-dioxo-3H,7H-azeto[2,1-b]furo[3,4-d][1,3]thiazin-6-yl]-2-furanacetamide

947723-87-7 M262745

5-Methoxy-2-mercaptobenzimidazole 37052-78-1 M262760

2-Methoxy-6-ethylnapthalene 21388-17-0 M262770

8-Methoxy Entecavir 2203740-23-0 M262885

2-Methoxy-5-methyl-γ-phenylbenzenepropanol 124937-73-1 M264465

4-(1-Methyl-5-morpholino-1H-benzo[d]imidazol-2-yl)butanoic Acid 1228552-02-0 M264490

3-Methoxy-α-methyl-L-tyrosine 6739-31-7 M264645

2-Methoxynaphthalene 1993-04-09 M264685

(1RS)-1-(6-Methoxy-2-naphthyl)ethanol (Naproxen Impurity K) 77301-42-9 M264740

Page 56: IMPURITY REFERENCE EP - LGC Ltd€¦ · (Anagrelide Impurity B) 1159977-03-3 A604740 2-Amino-5,6-dichloro-3(4H)-quinazoline Acetic Acid Hydrobromide (Anagrelide Impurity B) 1194434-39-3

56 20 Martin Ross Avenue North York, ON Canada, M3J 2K8

www.trc-canada.com [email protected] +1-416-665-9696

Chemical Name CAS Number Catalog Number

6-Methoxy-2-naphthoic Acid 2471-70-7 M264755

7-(4-Methoxybutoxy)-3,4-dihydroquinolin-2(1H)-one 1770391-64-4 M265040

1-Methylbiguanide Hydrochloride 1674-62-0 M265095

N-[[4-(3-Methoxypropoxy)-3-methyl-2-pyridinyl]methyl] Rabeprazole 935260-92-7 M265170

7-Methoxy-1-naphthaleneethanamine Hydrochloride 139525-77-2 M265585

2-(2-Methoxyphenoxy)ethylamine Hydrochloride 64464-07-9 M265650

2-[(2-Methoxyphenoxy)methyl]oxirane 2210-74-4 M265700

5-(4-Methoxyphenyl)-3-methyl-1-oxa-3-azaspiro[5.5]undecane Hydrochloride 93413-56-0 M265975

1-[1-(4-Methoxyphenyl)-2-(methylamino)ethyl]cyclohexanol Hydrochloride (rac N-Desmethyl Venlafaxine Hydrochloride)

93413-90-2 M266250

4-(3-Methoxypropoxy)-3-methylpicolinic Acid 1163685-31-1 M266555

1,1'-[(5E)-5-Methyl-7-oxo-5-undecene-1,11-diyl] Bis[Theobromine] 874747-30-5 M270000

2-(2-Methoxyphenoxy)-1,3-propanediol 14007-09-1 M271630

5-Methoxytryptamine 608-07-1 M271695

5-Methoxyuracil 6623-81-0 M271750

5-(S-Methyl) Albendazole 80983-45-5 M271950

Methyl 4-Acetylamino-5-chloro-2-methoxybenzoate 4093-31-6 M275070

Methyl 4-Acetamido-2-methoxybenzoate 4093-29-2 M275220

4'-Methylacetophenone 122-00-9 M275305

Methyl 4-Methyl-6-(3-nitrophenyl)-2-oxo-cyclohex-3-enyl Carboxylate (Mixture of Diastereomers)

M275370

(2Z)-2-Methyl-3-phenyl-2-propenal 66051-14-7 M275395

O-Methyl Albuterol 18910-70-8 M276580

N2-Methyl Alfuzosin 98902-34-2 M276650

N-[4-(Methylamino)benzoyl]-L-glutamic Acid 52980-68-4 M285680

N-[2-[(Methylamino)carbonyl]benzoyl] Amlodipine 721958-72-1 M285800

α-[2-(Methylamino)ethyl]benzyl Alcohol 42142-52-9 M286120

4-Methyl-5-[(2-aminoethyl)thiomethyl]imidazole Dihydrochloride 38603-72-4 M286500

1-[3-(Methylamino)-1-(2-thienyl)propyl]-2-naphthalenol (Duloxetine Impurity)

1346599-09-4 M287190

4-[3-(Methylamino)-1-(2-thienyl)propyl]-1-naphthalenol Hydrochloride (Duloxetine Impurity)

953028-76-7 M287200

2-[3-(Methylamino)-1-(2-thienyl)propyl]-1-naphthalenol Hydrochloride 1033719-36-6 M287210

N-Methyl Amisulpride 1391054-22-0 M287320

O-Methyl Atorvastatin Calcium Salt 887196-29-4 M288270

m-Methyl Atomoxetine Hydrochloride 873310-28-2 M288275

p-Methyl Atomoxetine Hydrochloride 873310-31-7 M288280

O-Methyl Atovaquone 129700-41-0 M288300

endo-9-Methyl-9-azabicyclo[3.3.1]nonan-3-amine 76272-56-5 M288600

rel-(1R,3S,5S)-8-Methyl-8-azabicyclo[3,2,1]oct-6-en-yl-2-hydroxy-2,2-dithiophen-2-yl acetate

136310-66-2 M288620

Page 57: IMPURITY REFERENCE EP - LGC Ltd€¦ · (Anagrelide Impurity B) 1159977-03-3 A604740 2-Amino-5,6-dichloro-3(4H)-quinazoline Acetic Acid Hydrobromide (Anagrelide Impurity B) 1194434-39-3

57 20 Martin Ross Avenue North York, ON Canada, M3J 2K8

www.trc-canada.com [email protected] +1-416-665-9696

Chemical Name CAS Number Catalog Number

N’-(1-Methylazepan-4-yl)benzohydrazine 117078-69-0 M288685

Albendazole Impurity G 20367-38-8 M288735

4-Methylbenzenesulfonic Acid Monohydrate 6192-52-5 M288740

5-Methyl-1,3-benzenediacetonitrile 120511-74-2 M288865

α-[(2-Methoxyphenoxy)methyl]-1-piperazineethanol 162712-35-8 M293015

1-Methyl Biguanide Sulfate Metformin EP Impurity E Sulfate

36801-25-9 M294051

9-Methyl Biotin (mixture of diastereomers) 415725-35-8 M294075

5-(4'-Methyl-2-biphenyl)tetrazole 120568-11-8 M294135

[1-Methyl-5-bis(2’-hydroxyethyl)aminobenzimidazolyl-2]butanoic Acid Ethyl Ester

3543-74-6 M294190

N-Methyl-N,N-bis(2-pyridylethyl)amine 5452-87-9 M294215

(16β)-16-Methyl-17,21-bis(1-oxopropoxy)pregna-1,4,9(11)-triene-3,20-dione 52092-12-3 M294225

Methyl 6-Bromo-2-napthoate 33626-98-1 M294305

6-O-Methyl Codeine 2859-16-7 M294500

12-O-Methyl Clarithromycin (~90%) 128940-83-0 M294630

N-Methyl-4-[1-(4-chlorophenyl)-1-phenylethoxy)hexahydroazepine 61771-18-4 M295095

N-Methyl-N-(3-chloropropyl)homoveratrylamine Hydrochloride 36770-75-9 M295155

3-Methyl 3-De(methoxymethyl) Cefpodoxime 947692-14-0 M295700

N-Methyl Formoterol Fumarate (2:1) (Mixture of Diastereomers)

1795133-97-9 M295950

Methylcyanocarbamate 21729-98-6 M296475

N-Methyl 7,8-didehydronaltrexone Bromide (Mixture of Diastereomers, >90%)

1027638-96-5 M302140

16β-Methyl-17α,21-Dihydroxypregna-1,4-diene-3,20-dione 18383-24-9 M302195

N'-Methyl-N,N-diphenylurea 13114-72-2 M303740

Methyl Di(2-thienylglycolate) 26447-85-8 M303765

D-α-Methyl DOPA 2799-15-7 M303790

rac 3-O-Methyl DOPA 7636-26-2 M303805

L-α-Methyl DOPA Dimethyl Ether Hydrochloride 5486-79-3 M303830

15β-Methyl Drospirenone M303850

Methylene-Bis Paroxetine Dihydrochloride M303940

1,1’-Methylene Bis[Theobromine] 77196-87-3 M303945

6,6’-Methylenebis[(3RS)-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-1,2,3,9-tetrahydro-4H-carbazol-4-one (Ondansetron Impurity B)

1076198-52-1 M303950

2,2’-Methylene Bis[Ranitidine] 207592-21-0 M304005

1,1’-N-[Methylenebis(sulphanediylethylene)]bis(N’-methyl-2-nitroethene-1,1-diamine

1331637-48-9 M304100

6-Methylene Progesterone Acetate 32634-95-0 M304220

Page 58: IMPURITY REFERENCE EP - LGC Ltd€¦ · (Anagrelide Impurity B) 1159977-03-3 A604740 2-Amino-5,6-dichloro-3(4H)-quinazoline Acetic Acid Hydrobromide (Anagrelide Impurity B) 1194434-39-3

58 20 Martin Ross Avenue North York, ON Canada, M3J 2K8

www.trc-canada.com [email protected] +1-416-665-9696

Chemical Name CAS Number Catalog Number

4,4'-[[(1-Methylethyl)imino]bis[(2-hydroxy-3,1-propanediyl)oxy]]bis-benzeneacetamide (Atenolol Impurity F)

87619-83-8 M304230

3-Methylene Ropinirole M304245

6,6-Methylene Bis[5-chlorobenzooxazol-2(3H)-one] M304380

4-Methyl Estradiol 6171-48-8 M304690

2-Methoxy-5-methyl-N,N-bis(1-methylethyl)-γ-phenyl-benzenepropanamine (2E)-2-Butenedioate

124935-89-3 M304800

2-(1-Methylethoxy)ethyl ester-4-[2-hydroxy-3-[(1-methylethyl)amino]propoxy] benzoic Acid

864544-37-6 M304833

1,1’-[(1-Methylethyl)imino]bis[3-[4-(2-methoxyethyl)phenoxy]-2-propanol (Mixture of Diastereomers)

154784-36-8 M304900

N-[[cis-4-(1-Methylethyl)cyclohexyl]carbonyl]-D-phenylalanine (Nateglinide Impurity)

105816-06-6 M304905

1-Methyl Ethynyl Estradiol 15071-66-6 M304960

4-Methyl Ethynyl Estradiol 155683-61-7 M304965

2-Methyl Ethynyl Estradiol 3240-39-9 M304975

8-Methyl Etodolac 41340-19-6 M305020

Methopterine 2410-93-7 M305370

3-(5-Methyl-3-phenyl-4-isoxazolyl)benzenesulfonyl Chloride 1709956-95-5 M305725

Methyl (5-((2-methyl-4-oxopentan-2-yl)thio)-1H-benzo[d]imidazol-2-yl)carbamate M305755

6α-Methyl Hydrocortisone 21-Acetate 1625-11-2 M312520

Methyl 4-Hydroxy-2H-1,2-benzothiazine-3-carboxylate 1,1-Dioxide 35511-14-9 M312590

Methyl 4-Hydroxy-2-methyl-2H-1,2-benzothiazine-3-carboxylate 1,1-Dioxide 35511-15-0 M312845

4,4',4''-Methylidynetrisbenzonitrile (Letrozole Impurity) 113402-31-6 M312950

1-Methylindazole-3-carboxylic Acid (Granisetron Impurity D) 50890-83-0 M313455

N-[[N-Methyl-N-[(2-isopropyl]-4-thiazolyl)methyl)amino]carbonyl-L-valine Carboxylic Acid

154212-61-0 M314850

5-Methylisoxazole-4-carboxylic Acid 42831-50-5 M315000

rac-4’-Methyl Ketoprofen 107257-20-5 M315080

N-Methyl Desloratadine 38092-89-6 M316500

N-Despropionyl, N-(2-Methyl-3-oxo-pentanoyl) Remifentanil M316750

1-Methyl Mebendazole 132119-11-0 M320150

(2α)-Methyl Megestrol Acetate 907193-65-1 M320240

(2β)-Methyl Megestrol Acetate 1259198-59-8 M320245

2(α/β)-Methyl Megestrol Acetate (Mixture of Diastereomers)

1259198-59-8 M320250

Methyl Mycophenolate 31858-66-9 M320540

O-Methyl Mycophenolate Mofetil (EP Impurity D) 1322681-37-7 M320545

1-Methyl-4-[5-(2-methylsulfamoylethyl)-1H-indol-3-yl]pyridinium Chloride M321050

Methyl 4-[β-(5-Methylpyrazine-2-carboxamido)ethyl]benzene Sulfonamide Carbamate

33288-74-3 M322900

N-Methyl-1-(2-methyl-2,3,4,9-tetrahydro-1H-pyrido[3,4-b]indol-6-yl)methanesulfonamide Succinate

M322955

Page 59: IMPURITY REFERENCE EP - LGC Ltd€¦ · (Anagrelide Impurity B) 1159977-03-3 A604740 2-Amino-5,6-dichloro-3(4H)-quinazoline Acetic Acid Hydrobromide (Anagrelide Impurity B) 1194434-39-3

59 20 Martin Ross Avenue North York, ON Canada, M3J 2K8

www.trc-canada.com [email protected] +1-416-665-9696

Chemical Name CAS Number Catalog Number

N-Methyl-1-(methylthio)-2-nitroethenamine 61832-41-5 M323020

Methyl-1-naphthalenemethylamine 14489-75-9 M323140

N-Methylnitroacetamide 72078-82-1 M323440

Methyl 2-methoxy-5-(methylsulfonyl)benzoate 63484-12-8 M323525

1-Methyl-5-nitro-1H-benzimidazole-2-butanoic Acid Ethyl Ester 3543-72-4 M323645

2-Methyl-5-nitroimidazole 696-23-1 M323765

1-Methyl-4-nitro-5-thioimidazole 6339-54-4 M324685

(2S)-1-(2-Methylpropanoyl)pyrrolidine-2-carboxylic Acid 23500-15-4 M324870

N-Methyl Pemetrexed 869791-42-4 M325465

5-Methyl-2-[(2-nitrophenyl)amino]-3-thiophenecarbonitrile 138564-59-7 M325570

N-Methyl-3-phenylpropylamine 23580-89-4 M325690

4-[β-(6-Methylpyrazinyl-2-carboxamido)ethyl]benzene Sulfonamide 1346600-54-1 M325705

2-[(RS)-(4-Methylphenyl)phenylmethoxy]-N,N-dimethylethanamine Hydrochloride

4024-34-4 M325788

N-Methyl Pantoprazole (Mixture of 1 and 3 isomers)

624742-53-6 M325866

N-Methyl Paroxetine 110429-36-2 M325870

1-Methyl-4-phenyl-1,2,3,6-tetrahydropyridine 28289-54-5 M325910

(S,S’)-3-Methyl-1-(2-piperidinophenyl)butylamine N-Acetyl-glutamate Salt 219921-94-5 M325925

4-[β-(5-Methylpyrazinyl-2-carboxamido)ethyl]benzene Sulfonamide 33288-71-0 M325946

2'-O-Methyl Paclitaxel 156413-67-1 M326135

N10-Methyl Pteroic Acid 5623-18-7 M326265

7'-Methyl-2'-propyl-2,5'-bi-1H-benzimidazole 884330-09-0 M326320

6-Methyl Risperidone 1346602-28-5 M326330

N-(Methylsulfonyl)-4-(desnitro) Nimesulide 905858-63-1 M326485

N-Methylsulfonyl Nimesulide 51765-72-1 M326490

1-Methylpiperazine 109-01-3 M326495

4-(2-Methylpropyl)benzeneethanol 36039-35-7 M326900

2-Methyl Simvastatin (Mixture Of Diasteroisomers) 774611-54-0 M327030

1-(3-Methoxyphenyl)ethanol 23308-82-9 M329600

N-Methyl-1-(2,3,4,9-tetrahydro-1H-pyrido[3,4-b]indol-6-yl)methanesulfonamide Succinate M329800

N-Methyltaxol C 153083-53-5 M330165

N-Methyl-5-tetrazolethiol 13183-79-4 M330260

N-Methyl Topiramate 97240-80-7 M330295

5-Methyl-1,3,4-thiadiazol-2-thiol 29490-19-5 M330305

(3S)-N-Methyl-γ-(1-naphthalenyloxy)-3-thiophenepropanamine 959392-22-4 M330535

2-Methyl-Celecoxib 170570-09-9 M330703

1-Methyl-2-(methylthio)imidazole 14486-52-3 M330840

Methyl Triphenylmethyl Ether 596-31-6 M330975

Page 60: IMPURITY REFERENCE EP - LGC Ltd€¦ · (Anagrelide Impurity B) 1159977-03-3 A604740 2-Amino-5,6-dichloro-3(4H)-quinazoline Acetic Acid Hydrobromide (Anagrelide Impurity B) 1194434-39-3

60 20 Martin Ross Avenue North York, ON Canada, M3J 2K8

www.trc-canada.com [email protected] +1-416-665-9696

Chemical Name CAS Number Catalog Number

4-Methyl-6-(2,4,4-trimethylpentyl)-2H-pyran-2-one 50650-75-4 M331260

2-Methyl-N-[3-(trifluoromethyl)phenyl]propanamide 1939-27-1 M331270

5''''-Methyl-apixaban 1686149-74-5 M331278

(3-Methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl)methyl Acetate 112525-75-4 M337655

3-Methylxanthine 1076-22-8 M338570

Metoclopramide N-Oxide 171367-22-9 M338695

Metoprolol Acid 56392-14-4 M338785

ortho-Metoprolol 163685-38-9 M338800

Miconazole Impurity H 181931-30-6 M342490

Miconazole Impurity I 47363-37-1 M342495

Milbemycin A4 51596-11-3 M344275

Milbemycin D 77855-81-3 M344290

Milbemycin A3 51596-10-2 M344295

7-O-[(Methylsulfanyl)methyl]moxidectin M354050

Mirtazapine N-Oxide 155172-12-6 M365010

Mitomycin A 4055-39-4 M371890

Modafinil Carboxylate 63547-24-0 M482510

Modafinil Carboxylate Methyl Ester 63547-25-1 M482515

Modafinil Sulfone 118779-53-6 M482520

Moexipril Diketopiperazine 103733-51-3 M485340

Mometasone 105102-22-5 M489995

Mometasone Furoate Impurity A 83880-65-3 M490100

Monodecarboxy Piperacilloic Acid (Mixture of Diastereomers)

64817-23-8 M526700

2’-Monodehydroxy-2’-chloro Ganciclovir 108436-36-8 M526800

N10-Monodesmethyl Rizatriptan 144034-84-4 M539500

Monodesmethylchlorpheniramine 20619-12-9 M539520

(R,R)-Montelukast Bis-sulfide (~90%) 1187586-61-3 M567970

(R,S)-Montelukast Bis-sulfide 1187586-58-8 M567975

ent-Montelukast Sodium Salt 190078-45-6 M567995

cis-Montelukast 774538-96-4 M568005

Montelukast Sulfoxide (Mixture of Diastereomers)

909849-96-3 M568020

Montelukast Styrene 918972-54-0 M568030

Montelukast Methyl Ketone 937275-23-5 M568040

2-[4-(4-Morpholinyl)-1,2,5-thiadiazol-3-yl]-rac-Timolol Ether 610271-56-2 M725165

4-(4-Morpholinyl)-1,2,5-thiadiazol-3(2H)-one 1-Oxide 75202-36-7 M725175

2-epi-Moxidectin M744805

Mucidin 52110-55-1 M815200

Page 61: IMPURITY REFERENCE EP - LGC Ltd€¦ · (Anagrelide Impurity B) 1159977-03-3 A604740 2-Amino-5,6-dichloro-3(4H)-quinazoline Acetic Acid Hydrobromide (Anagrelide Impurity B) 1194434-39-3

61 20 Martin Ross Avenue North York, ON Canada, M3J 2K8

www.trc-canada.com [email protected] +1-416-665-9696

Chemical Name CAS Number Catalog Number

Mycophenolate Mofetil N-Oxide (EP Impurity G) 224052-51-1 M831470

Mycophenolic Acid Lactone (EP Impurity H) 79081-87-1 M831535

Nabumetone Dimer Impurity 343272-53-7 N200515

Naloxone 3-Methyl Ether 70866-64-7 N285020

NAP 226-90 139306-10-8 N325000

1-Naphthol 90-15-3 N367990

N-(1-Naphthylmethyl)methylamine hydrochloride 65473-13-4 N372950

(S)-Naproxen Ethyl Ester 31220-35-6 N377545

(S)-Naproxen Methyl Ester 26159-35-3 N377550

ent-Nateglinide 105816-05-5 N379365

Nelfinavir Sulfone 1041389-29-0 N389765

Nelfinavir Sulfoxide 1041389-28-9 N389770

Nemadipine B 79925-38-5 N389800

Neodigoxin 55576-67-5 N389943

Nevirapine Dimer 1391054-30-0 N391290

8-epi Nicergoline 58001-19-7 N394555

m-Nifedipine 21881-77-6 N457015

4-Nitroaniline 100-01-6 N491770

2-Nitroaniline 88-74-4 N491775

4-(2-Nitroanilino)pyridine 25551-59-1 N491785

4-Nitro-5-desnitro Tinidazole 25459-12-5 N493785

5-Nitro-2-furfuraldazine 112537-96-9 N493830

3-(5-Nitrofurfurylideneamino)hydantoic Acid 63981-22-6 N493885

5-O-(4-nitrobenzoyl)moxidectin N494900

4-Nitro Lenalidomide 827026-45-9 N496395

4-Nitrophenol 100-02-7 N496945

3-Nitro-4-phenoxy-5-sulfamoylbenzoic Acid 28328-53-2 N496950

4-Nitro-2-phenoxyaniline 5422-92-4 N496975

5-(4-Nitrophenyl)-2-furaldehyde Azine 301359-05-7 N503530

5-(4-Nitrophenyl)furfural 7147-77-5 N503535

5-(4-Nitrophenyl)-2-furaldehyde-(2-carboxymethyl) Semicarbazone 57268-33-4 N503540

4-(4-Nitrophenyl)-3-morpholinone 446292-04-2 N504425

3-Nitrosalicylic Acid 85-38-1 N520900

5-Nitrosalicylic Acid 96-97-9 N520910

5-Nitroso-2,4,6-triaminopyrimidine 1006-23-1 N546975

2-Nitro-4-thiocyanato Aniline 54029-45-7 N565320

Nizatidine Sulfoxide 102273-13-2 N598510

Page 62: IMPURITY REFERENCE EP - LGC Ltd€¦ · (Anagrelide Impurity B) 1159977-03-3 A604740 2-Amino-5,6-dichloro-3(4H)-quinazoline Acetic Acid Hydrobromide (Anagrelide Impurity B) 1194434-39-3

62 20 Martin Ross Avenue North York, ON Canada, M3J 2K8

www.trc-canada.com [email protected] +1-416-665-9696

Chemical Name CAS Number Catalog Number

Nizatidine Amide 188666-11-7 N598520

N-Nordextromethorphan Hydrochloride 1087-69-0 N672500

17-epi-Norethindrone 38673-36-8 N675985

Δ-5(10)-Norethindrone Acetate 19637-28-6 N675995

Δ-5(6)-Norethindrone Acetate 1175129-26-6 N676015

Norethynodrel 68-23-5 N676020

Δ-5(6)-Norethindrone 22933-71-7 N676030

Norethindrone 3-Ethyl Ether 96487-85-3 N676035

Norfentanyl 1609-66-1 N680978

D-(-)-Norgestrel 797-63-7 N689510

Nor Lidocaine Hydrochloride 7729-94-4 N713500

N1-Nornicergoline 35264-46-1 N756600

(R,S)-Nornicotine 5746-86-1 N757000

rac Norphenylephrine Hydrochloride (Phenylephrine Impurity A)

4779-94-6 N825500

Northioridazine Hydrochloride 13002-81-8 N830600

Nortriptyline Hydrochloride 894-71-3 N837000

Nor Verapamil Hydrochloride 67812-42-4 N877500

Nutriacholic Acid 4651-67-6 N925550

trans-1,2,3,4,4a,10,11,11a-Octahydro-N,N-dimethyl-5H-Dibenzo[a,d]cycloheptene-Δ5,γ-propylamine Hydrochloride

27867-02-3 O236425

L-(2S,3aS,7aS)-Octahydroindole-2-carboxylic Acid 80875-98-5 O236900

Olanzapine N-Oxide 174794-02-6 O253760

Olanzapine Lactam Impurity 1017241-34-7 O253765

Olanzapine Thiolactam Impurity 1017241-36-9 O253780

tert-Octylamine 107-45-9 O270820

4-[[2-(Octyloxy)benzoyl]amino]benzoic Acid 51444-79-2 O293260

Olmesartan Acid 144689-24-7 O550001

Olmesartan Lactone Impurity 849206-43-5 O550030

(E)-Olopatadine Hydrochloride 949141-22-4 O575005

Olopatadine N-Oxide 203188-31-2 O575010

Omeprazole N-Oxide 176219-04-8 O635015

Omeprazole Sulfide 73590-85-9 O635020

Omeprazole Sulfone 88546-55-8 O635025

Omeprazole Sulfone N-Oxide 158812-85-2 O635030

OPC 14714 203395-84-0 O667600

Orlistat Dimer Impurity 881900-54-5 O686510

Oseltamivir Acid 187227-45-8 O700980

Oseltamivir Acid Methyl Ester 208720-71-2 O701023

Page 63: IMPURITY REFERENCE EP - LGC Ltd€¦ · (Anagrelide Impurity B) 1159977-03-3 A604740 2-Amino-5,6-dichloro-3(4H)-quinazoline Acetic Acid Hydrobromide (Anagrelide Impurity B) 1194434-39-3

63 20 Martin Ross Avenue North York, ON Canada, M3J 2K8

www.trc-canada.com [email protected] +1-416-665-9696

Chemical Name CAS Number Catalog Number

3-Oxo-4-aza-5α-αndrost-1-ene-17β-carboxylic Acid 104239-97-6 O847250

3-Oxo-4-aza-5α-αndrost-1-ene-17β-carboxylic Acid Methyl Ester 103335-41-7 O847260

7-epi-10-Oxo-10-deacetyl Baccatin III 151636-94-1 O850100

10-Oxo Docetaxel 167074-97-7 O855800

11-Oxo Fluticasone Propionate 1219174-94-3 O856860

28-Oxo Ivermectin B1a (Impurity) 102190-55-6 O856970

1-Oxo Mirtazapine (Mirtazapine Impurity C) 191546-96-0 O857990

10-Oxo Mirtazapine (Mirtazapine Impurity F) 191546-97-1 O858000

10-Oxo Naltrexone 96445-14-6 O858200

6-Oxo Norethindrone Acetate 438244-27-0 O858290

6-Oxo D-(-)-Norgestrel 1175109-63-3 O858350

6-Oxo Mometasone Furoate Mometasone Furoate Impurity F

1305334-30-8 O858500

2-Oxo-5-vinylpyrrolidine-3-carboxamide 71107-19-2 O858775

(2-Oxopyrrolidin-1-yl)acetic Acid 53934-76-2 O859610

1-[(1-Oxopentyl)amino]-N-[[2'-(2H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-cyclopentanecarboxamide

748812-53-5 O859980

5-Oxo Rosuvastatin 1422619-13-3 O862000

2,2'-(4,4'-(Oxybis(butane-4,1-diyl))bis(piperazine-4,1-diyl))dipyrimidine Dihydrochloride O868540

2,2'-(4,4'-(Oxybis(butane-4,1-diyl))bis(piperazine-4,1-diyl))dipyrimidine-D16 Dihydrochloride O868542

3-Oxo-1,2-benzoisothiazoline-2-acetic Acid Methyl Ester 1,1-Dioxide 6639-62-9 O869775

1-Oxo Ibuprofen 65813-55-0 O870035

16-Oxo Ethynyl Estradiol 1350468-76-6 O870045

3-Oxo Ropinirole Hydrochloride 221264-21-7 O870400

4-epi-Oxytetracycline 14206-58-7 O877505

Paclitaxel C 153415-45-3 P132510

Paliperidone N-Oxide 761460-08-6 P141010

Palonosetron-3-ene Hydrochloride 135729-55-4 P165825

Pantoprazole Sulfone N-Oxide 953787-55-8 P183013

Pantoprazole Sulfone 127780-16-9 P183016

Pantoprazole Sulfide 102625-64-9 P183020

Para-Naphthol Duloxetine 949095-98-1 P191860

ent-Paroxetine Hydrochloride 130855-30-0 P205755

Penciclovir Monoacetate 97845-80-2 P221515

all-rac-trans-2,3,4,6,7-Pentamethyl-2-(4,8,12-trimethyltridecyl)-2,3-dihydrobenzofuran-5-ol P275530

all-rac-cis-2,3,4,6,7-Pentamethyl-2-(4,8,12-trimethyltridecyl)-2,3-dihydrobenzofuran-5-ol P275535

Perindopril De-2-((S)-ethyl 2-(Ethylamino)pentanoate) 111836-22-7 P287495

Perindopril Diketopiperazine 129970-98-5 P287525

Perindoprilat Lactam A 129970-99-6 P287570

Page 64: IMPURITY REFERENCE EP - LGC Ltd€¦ · (Anagrelide Impurity B) 1159977-03-3 A604740 2-Amino-5,6-dichloro-3(4H)-quinazoline Acetic Acid Hydrobromide (Anagrelide Impurity B) 1194434-39-3

64 20 Martin Ross Avenue North York, ON Canada, M3J 2K8

www.trc-canada.com [email protected] +1-416-665-9696

Chemical Name CAS Number Catalog Number

Perindoprilat Lactam B 130061-28-8 P287575

Perphenazine Sulfoxide 10078-25-8 P291105

4-(3-Phenothiazin-10-ylpropyl)-1-piperazineethanol 3533-97-9 P295320

Pheniramine Maleate 132-20-7 P297200

2-Phenoxylaniline 2688-84-8 P298200

((R)-1-phenyl-3,4-dihydroisoquinolin-2(1H)-yl)((S)-1-phenyl-3,4-dihydroisoquinolin-2(1H)-yl)methanone

2216750-52-4 P309025

Phenothiazine 92-84-2 P318040

L-Phenylalanine 63-91-2 P319415

4-Phenybutyl 2-Carboxyethylphosphinic Acid 83623-61-4 P319575

2-Phenylbutyric Acid 90-27-7 P319600

1,1'-(1,3-Phenylene)bis-1H-1,2,4-triazole 514222-44-7 P319830

Phenylephrone Hydrochloride 94240-17-2 P320670

α-Phenyl-α-ethylacetamide 90-26-6 P320790

Phenyl Ether 101-84-8 P321330

D-(-)-2-Phenylglycine 875-74-1 P327125

Phenylglycyl Cephalexin (Mixture of diastereomers) 72528-40-6 P327140

N-[(Phenylmethoxy)carbonyl]-L-valine 2-[(2-Amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]ethyl Ester

124832-31-1 P335895

3-Phenyl-1-propanol 122-97-4 P336065

(R)-2-Phenyl-2-pivalamidoacetic Acid 40610-41-1 P336320

1-Phenyl-1-(2-pyridyl)ethanol 19490-92-7 P336675

(S)-1-Phenyl-1,2,3,4-tetrahydroisoquinoline 118864-75-8 P336930

Pholcodine N-Oxide 433308-89-5 P351510

Pholcodine-N,N'-dioxide 433308-91-9 P351515

Phthaloyl Amlodipine 88150-62-3 P389900

Pilocarpic Acid Sodium Salt 92598-79-3 P441450

(1R)-(1S,2S,3R,5S)-Pinanediol-N-(N-pyrazinylphenylalaninoyl)-1-amino-3-methyl-butane-1-boronate

205393-22-2 P458530

N-Piperacillinyl Ampicillin 65772-67-0 P479960

Piperacilloic Acid 64817-22-7 P479970

5,5'-(Piperazine-2,5-diyl)bis(2-hydroxybenzamide) P480095

9-Desfluoro-9-(4-Methyl-piperazino)-10-Des(4-methylpiperazino)-10-Fluoro Ofloxacin

197291-75-1 P480450

2-Piperazinyl-4-amino-6,7-dimethoxyquinazoline 60547-97-9 P480500

3-(1-Piperazinyl)-1,2-benzisothiazole 87691-87-0 P480600

2,2'-(1,4-Piperazinediyl)bis[6,7-dimethoxy-4-quinazolinamine] (Terazosin Impurity)

102839-00-9 P480620

2-(1-Piperazinyl)pyrimidine 20980-22-7 P481300

2-Piperidinemethanamine 22990-77-8 P481965

α-(4-Piperidyl)benzhydrol 115-46-8 P481995

Page 65: IMPURITY REFERENCE EP - LGC Ltd€¦ · (Anagrelide Impurity B) 1159977-03-3 A604740 2-Amino-5,6-dichloro-3(4H)-quinazoline Acetic Acid Hydrobromide (Anagrelide Impurity B) 1194434-39-3

65 20 Martin Ross Avenue North York, ON Canada, M3J 2K8

www.trc-canada.com [email protected] +1-416-665-9696

Chemical Name CAS Number Catalog Number

(R)-Pramipexole Dihydrochloride 104632-27-1 P700745

Prazosin Hydrochloride 19237-84-4 P702325

Prednisolone 50-24-8 P703740

Prednisolone Acetate 52-21-1 P703750

Prednisolone 17,21-Diacetate 17652-24-3 P703790

Prednisolone 21-Propionate 5740-62-5 P703900

(R)-Pregabalin 148553-51-9 P704785

(S)-Pregabalin Lactam 181289-23-6 P704820

Pregna-5,16-dien-3β-ol Acetate 2118-32-3 P704940

Pregna-4,14-diene-3,20-dione 24377-08-0 P704950

Δ4-Pregnen-20α-ol-3-one 145-14-2 P712215

Progesterone Acetate 302-23-8 P755910

Promazine Hydrochloride 53-60-1 P756300

Promethazine Sulfoxide 7640-51-9 P757010

Propafenone Dimer Impurity (Mixture of diastereomers)

1346603-80-2 P757520

Propafenone Hydrochloride 2-Propen-1-one Impurity 1331636-87-3 P767400

9-Propenyladenine 4121-40-8 P768800

4-Propionamidophenol (Acetaminophen Impurity B) 1693-37-4 P783500

Propofol 4-Carboxylic Acid 13423-73-9 P829760

Propofol Isopropyl Ether 141214-18-8 P829820

(4-Propyl-2,3-dichlorohenoxy)acetic Acid P835208

(4-Propyl-2,3-dichlorohenoxy)acetic Acid-D3 P835209

1-Propyl Etodolac 57816-83-8 P835250

8-Propyl Etodolac 57817-27-3 P835255

Propylidine Ropinirole Hydrochloride (E/Z-Mixture)

221264-43-3 P835500

2-N-Propyl Pramipexole 1246815-83-7 P836000

Propyl Itraconazole 74855-91-7 P837500

2-n-Propyl-4-methyl-6-(1-methylbenzimidazol-2-yl)-benzimidazole 152628-02-9 P838280

5-(Propylthio)-1H-benzo[d]imidazole P838328

4-(Propylthio)-1,2-benzenediamine 66608-52-4 P838470

Pseudo Erythromycin A Enol Ether 105882-69-7 P839500

Pseudomonic Acid D Sodium 85178-60-5 P839520

2,4-Pteridinediamine-6-methanol 945-24-4 P840095

Pteroic Acid (>85%) 119-24-4 P840110

Pyochelin I and Pyochelin II P840365

2H,5H-Pyrano[4,3-b]pyranyl Mupirocin Sodium Impurity 116182-44-6 P840550

Z-Pyrantel Pamoate P840580

Page 66: IMPURITY REFERENCE EP - LGC Ltd€¦ · (Anagrelide Impurity B) 1159977-03-3 A604740 2-Amino-5,6-dichloro-3(4H)-quinazoline Acetic Acid Hydrobromide (Anagrelide Impurity B) 1194434-39-3

66 20 Martin Ross Avenue North York, ON Canada, M3J 2K8

www.trc-canada.com [email protected] +1-416-665-9696

Chemical Name CAS Number Catalog Number

2,5-Pyrazinediethanol 4744-51-8 P840815

Pyrazinenitrile 19847-12-2 P841100

17-(3-Pyridinyl)-androst-4-en-3-one 1382474-09-0 P991668

N-(2-Pyridinylmethyl)-2,5-bis(2,2,2-trifluoroethoxy)benzamide (Flecainide Impurity)

57415-36-8 P991690

2,2’-(1,4-Piperazinediyl)bis-pyrimidine 84746-24-7 P991770

2,4'-(2-Pyridinyl-2methylene)diphenol 16985-05-0 P991840

4-(2-Pyridinyl)benzaldehyde 127406-56-8 P992125

4-(2-Pyridinyl)benzoic Acid T P992140

2-Pyridinol 72762-00-6 P992190

3-Pyridylsulfonic Acid 636-73-7 P992390

3,3’-(Pyrimidine-2,4-diyl)bis(1-methyl-1H-indole) P997353

2-Pyrrolidinyl-3-acetyl Desmorpholinylrocuronium Bromide 1190105-66-8 P998535

2-Pyrrolidinyl Desmorpholinylrocuronium Bromide 1190105-65-7 P998540

2-Pyrrolidinone 616-45-5 P998990

Quetiapine Dimer Impurity 945668-94-0 Q509960

Quetiapine Hydroxy Impurity Dihydrochloride Salt 329218-14-6 Q510010

Quetiapine Impurity-N 1800291-86-4 Q510015

Quetiapine N-Oxide 1076199-40-0 Q510020

Quetiapine Sulfone 329216-65-1 Q510025

Quetiapine Sulfoxide 329216-63-9 Q510030

Quinapril Diketopiperazine 103733-49-9 Q670005

Quinaprilat 82768-85-2 Q670010

6-Quinoxalinamine 6298-37-9 Q750010

Rabeprazole N-Oxide 924663-38-7 R070495

Rabeprazole Sulfone 117976-47-3 R070505

Rabeprazole Sulfide 117977-21-6 R070510

Rabeprazole Sulfone N-Oxide 924663-37-6 R070515

Raloxifene N-Oxide 195454-31-0 R100050

Ramipril Diketopiperazine 108731-95-9 R111008

Ramiprilat 87269-97-4 R111010

Ramiprilat Diketopiperazine (Mixture of Diastereoisomers)

108736-10-3 R111030

(2R,3aR,6aR)-Ramipril 129939-63-5 R111035

Ramipril Isopropyl Ester 295328-72-2 R111045

N- Hydro Ranitidine 66356-53-4 R120005

Ranitidine N-Oxide 73857-20-2 R120010

Ranitidine S-Oxide 73851-70-4 R120015

Page 67: IMPURITY REFERENCE EP - LGC Ltd€¦ · (Anagrelide Impurity B) 1159977-03-3 A604740 2-Amino-5,6-dichloro-3(4H)-quinazoline Acetic Acid Hydrobromide (Anagrelide Impurity B) 1194434-39-3

67 20 Martin Ross Avenue North York, ON Canada, M3J 2K8

www.trc-canada.com [email protected] +1-416-665-9696

Chemical Name CAS Number Catalog Number

(R)-Repaglinide Ethyl Ester 147770-08-9 R144530

Resorufin 635-78-9 R146515

Rhein 478-43-3 R318500

Ribavirin Carboxylic Acid 39925-19-4 R414485

1-β-D-Ribofuranosyl-1,2,4-triazole-3-carboxylic Acid Methyl Ester (Ribavirin Impurity H)

38934-69-9 R415725

Rifamycin B 13929-35-6 R508170

Rifamycin O 14487-05-9 R508190

Rifamycin SV Sodium 14897-39-3 R508200

Rifamycin S 13553-79-2 R508210

Rifogal 6998-60-3 R509625

Risperidone E-Oxime 691007-09-7 R525015

Risperidone Z-Oxime Impurity 132961-05-8 R525016

Risperidone Carboxylate Impurity 1346603-86-8 R525025

Bis(thiazol-5-yl-methyl)[carbonylbis[imino[(2S,3S,5S)-3-hydroxy-1,6-diphenylhexane-5,2-diyl]]]dicarbamate

R535035

4-epi-Ritonavir 1414933-81-5 R536000

(R)-Rivastigmine Tartrate Salt R540990

(R)-Rivastigmine 415973-05-6 R541005

Rizatriptan N10-Oxide 260435-42-5 R545010

RO 2433 863329-66-2 R637200

(S)-Ropivacaine N-Isopropyl 265120-58-9 R674990

(R)-(+)-Ropivacaine Hydrochloride 112773-90-7 R675005

(3R,5R)-Rosuvastatin Sodium Salt R700510

ent-Rosuvastatin Sodium Salt R700515

ent-Rosuvastatin tert-Butyl Ester 615263-60-0 R700520

Rosuvastatin Lactone 503610-43-3 R700550

(Z)-Roxithromycin 134931-00-3 R700855

Saccharin N-(2-Acetic Acid Ethyl Ester) (Piroxicam Impurity E)

24683-20-3 S080820

Saccharin N-(2-Acetic Acid Isopropyl Ester) (Piroxicam Impurity F)

76508-37-7 S080830

Salbutamon Hydrochloride 41489-89-8 S085500

Salicylazoiminopyridine (>85%) 66030-25-9 S088100

p-Salicylic Acid 99-96-7 S088120

Salicylic Acid 69-72-7 S088125

Salsalate 552-94-3 S095700

Saluamine 3086-91-7 S100500

Sancycline Hydrochloride 6625-20-3 S111500

Scopine Di(2-thienylglycolate) 136310-64-0 S199965

Page 68: IMPURITY REFERENCE EP - LGC Ltd€¦ · (Anagrelide Impurity B) 1159977-03-3 A604740 2-Amino-5,6-dichloro-3(4H)-quinazoline Acetic Acid Hydrobromide (Anagrelide Impurity B) 1194434-39-3

68 20 Martin Ross Avenue North York, ON Canada, M3J 2K8

www.trc-canada.com [email protected] +1-416-665-9696

Chemical Name CAS Number Catalog Number

Scopine Methobromide 1508-46-9 S199985

DL-Serine Hydrazide Hydrochloride 55819-71-1 S271015

(R,R)-Sertraline Hydrochloride 79645-15-1 S279965

rac-trans-Sertraline 79836-45-6 S279980

rac-cis-Sertraline Mandelate S279985

Sesamol 533-31-3 S280600

Sildenafil N-Oxide 1094598-75-0 S435035

Silodosin Methyl Ester S465085

Simvastatin Dimer 476305-24-5 S485010

Simvastatin Hydroxy Acid Sodium Salt 101314-97-0 S485050

Sitagliptin Triazecine Analog S491015

ent-Sitagliptin Phosphate 823817-58-9 S491025

(R)-Sitagliptin rac-Fumarate Adduct (mixture of diastereomers) 2088771-60-0 S491040

SN-38 86639-52-3 S589950

Sodium Stibogluconate 16037-91-5 S670963

Sofosbuvir 5'-Desphosphate 3'-O-[(S)-Phosphate] 1337482-15-1 S675610

7β-Spironolactone 33784-05-3 S683010

Stavudine 3056-17-5 S685250

N-(2-Succinyl) Phenylephrine (Mixture of Diastereomers)

915278-80-7 S688850

Sulfamerazine 127-79-7 S689000

2-(2-Sulfoethyl)pseudourea 25985-57-3 S689065

Sulfanilic Acid 121-57-3 S689095

Sulphanilamide 63-74-1 S689100

Sulfadimethoxine N4-Acetate 555-25-9 S689180

N-Succinyl-L-tyrosine 374816-32-7 S692150

Sulfasalazine 3-Isomer 66364-71-4 S699130

3,3'-Sulfonylbis(N-(4-cyano-3-(trifluoromethyl)phenyl)-2-hydroxy-2-methylpropanamide) (Mixture of Diastereomers)

S699335

3-Sulfino-D-valine 23315-18-6 S733405

Sumatriptan N-Oxide 212069-94-8 S810010

Tachysterol3 (80%) 17592-07-3 T004120

Tacrolimus Methyl Acryl Aldehyde 109466-74-2 T004150

ent-Tadalafil 629652-72-8 T004505

cis-Tadalafil 171596-27-3 T004520

cis-ent-Tadalafil 171596-28-4 T004530

(S)-Tamsulosin Hydrochloride 106463-19-8 T006355

Taxol F 173101-56-9 T010020

Telmisartan Amide 915124-86-6 T017020

Page 69: IMPURITY REFERENCE EP - LGC Ltd€¦ · (Anagrelide Impurity B) 1159977-03-3 A604740 2-Amino-5,6-dichloro-3(4H)-quinazoline Acetic Acid Hydrobromide (Anagrelide Impurity B) 1194434-39-3

69 20 Martin Ross Avenue North York, ON Canada, M3J 2K8

www.trc-canada.com [email protected] +1-416-665-9696

Chemical Name CAS Number Catalog Number

Telmisartan Dimer Impurity 884330-14-7 T017025

Telmisartan tert-Butyl Ester 144702-26-1 T017030

(S)-Tenofovir Disoproxil Fumarate 1432630-26-6 T018506

cis-Terbinafine Hydrochloride 176168-78-8 T107490

Terbinafine Dimer Impurity Dihydrochloride Salt T107510

Tert-butyl 2-[(4R,6S)-2,2-Dimethyl-6-[(methylcarbonyloxy)methyl]-1,3-dioxan-4-yl]acetate

154026-95-6 T117700

∆6-Testosterone 2484-30-2 T155030

Tetra-tert-butyldiphenoquinone 2455-14-3 T289225

Tetracycline 60-54-8 T291413

2,3,4,5-Tetradehydro Alfuzosin Hydrochloride 98902-29-5 T291430

Tetraethylcystamine 589-32-2 T291435

α,α,α’,α’-Tetramethyl-5-bromomethyl-1,3-benzenediacetonitrile 120511-84-4 T291490

α,α,α’,α’-Tetramethyl-5-(dibromomethyl)-1,3-benzenediacetonitrile 1027160-12-8 T291495

α,α,2,6-Tetrachloro-toluene 81-19-6 T292065

9-(Tetrahydro-5-methyl-2-furyl)adenine 6612-70-0 T292330

1-(Tetrahydro-2-furoyl)-piperazine 63074-07-7 T293475

Tetrahydro Furosemide 4793-38-8 T293540

1,2,3,4-Tetrahydro-4,6-dihydroxy-2-methyl-isoquinoline 23824-24-0 T293575

1,2,3,4-Tetrahydro-4,8-dihydroxy-2-methyl-isoquinoline 23824-25-1 T293580

(S)-1,2,3,4-Tetrahydroisoquinoline-3-carboxylic Acid 74163-81-8 T293755

1,2,3,9-Tetrahydro-9-methyl-4H-carbazol-4-one 27387-31-1 T293920

1,2,3,9-Tetrahydro-9-methyl-3-methylene-4H-carbazol-4-one 99614-64-9 T293930

11β,16α,17α,21-Tetrahydroxypregna-1,4-diene-3,20-dione 13951-70-7 T296075

3,5,3',5'-Tetraiodo Thyroacetamide 176258-88-1 T296120

3,5,3',5'-Tetraiodo Thyroacetic Acid 67-30-1 T296125

3,5,3',5'-Tetraiodo Thyroaldehyde 2016-06-0 T296135

3,3',5,5'-Tetraiodo Thyroformic Acid, ~90% 2055-97-2 T296150

3,5,3',5'-Tetraiodo Thyromandelic Acid 93647-48-4 T296170

α-Tetralone 529-34-0 T298580

N,1,7,7-Tetramethylbicyclo[2.2.1]heptan-2-amine Hydrochloride 22321-23-9 T300915

4,4-Tetramethyleneglutarimide 1075-89-4 T302880

α,α,α’,α’-Tetramethyl-5-methyl-1,3-benzenediacetonitrile 120511-72-0 T303615

1-[4-[(1,2,3,4-Tetrahydro-2-oxo-7-quinolinyl)oxy]butyl] Aripiprazole 1424857-63-5 T310270

N-1,3,4-Thiadiazol-2-ylacetamide 5393-55-5 T343950

Thiamiprine 5581-52-2 T344120

N1,N1’-[2,4-Thiazolediylbis(methylenethio-2,1-ethanediyl)]bis(N’-methyl-2-nitro-1,1-ethenediamine)

1193434-62-6 T344220

Thiazolylacetylglycine Oxime 178949-03-6 T344230

Page 70: IMPURITY REFERENCE EP - LGC Ltd€¦ · (Anagrelide Impurity B) 1159977-03-3 A604740 2-Amino-5,6-dichloro-3(4H)-quinazoline Acetic Acid Hydrobromide (Anagrelide Impurity B) 1194434-39-3

70 20 Martin Ross Avenue North York, ON Canada, M3J 2K8

www.trc-canada.com [email protected] +1-416-665-9696

Chemical Name CAS Number Catalog Number

1,3-Thiazol-5-ylmethyl N-[(1S,2S,4S)-4-(acetylamino)-1-benzyl-2-hydroxy-5-phenylpentyl]carbamate

1010808-43-1 T344290

3-(Thiophen-2-yl)propionic Acid 5928-51-8 T344395

3-Thiopheneethanoic Acid 6964-21-2 T344870

3-Thiophenemalonic Acid 21080-92-2 T368155

Thioridazine 2-Sulfone 14759-06-9 T368810

Thioridazine 5-Sulfoxide (Mixture of Diastereomers) 7776-05-08 T368815

3’-β-Thymidine 16053-52-4 T412005

Thymine 65-71-4 T412150

Ticabesone Propionate 73205-13-7 T437600

(R)-Timolol 26839-76-9 T443695

(R)-(+)-Timolol Maleate 26839-77-0 T443705

Tofacitinib impurity L 1675248-19-7 T528015

Tofacitinib impurity N 1260614-73-0 T528020

Tofacitinib Impurity Z 477600-76-3 T528030

o-Toluidine Chloride 636-21-5 T536215

2-(p-Tolyl)propionic Acid 938-94-3 T536780

Tosylurethane 5577-13-9 T686900

Trandolapril Diketopiperazine 149881-40-3 T713515

Trandolaprilat 87679-71-8 T713540

cis-Tranexamic Acid 1197-17-7 T714500

Tranexamic Acid Dimer 93940-19-3 T714515

Trazodone N-Oxide 55290-68-1 T718510

Triacetyl Aloe-emodin (Impurity A) 25395-11-3 T734000

Tri-o-tolyl-Phosphine Oxide 6163-63-9 T765600

Triamcinolone 21-Acetate 3859-65-2 T767290

1,2,4-Triazole-3-carboxylic Acid 4928-87-4 T767395

(1,2,4-Triazol-4-yl) Itraconazole 854372-77-3 T767525

3-(4H-1,2,4-Triazol-4-yl)-1H-pyrazole-4-carboxamide 1346604-13-4 T767570

α,2,6-Trichloro-toluene 2014-83-7 T773600

7-O-(Triethylsilyl)-2’-O-tert-butyl(dimethyl)silyl Paclitaxel 156413-61-5 T777810

13-O-(Triethylsilyl) Baccatin III 208406-86-4 T777930

7-O-(Triethylsilyl) Paclitaxel 148930-55-6 T778055

4-(Trifluoromethyl)aniline 455-14-1 T791050

2-(4-(3-(2-(Trifluoromethyl)-10H-phenothiazin-10-yl)piperazin-1-yl)ethyl Undecanoate

13220-06-9 T791155

1-(4-(Trifluoromethoxy)phenyl)-2-thiourea 142229-74-1 T791590

3,3',5-Triiodo Thyroacetic Acid 51-24-1 T795320

3,3’,5’-Triiodo-L-thyronine 5817-39-0 T795350

Page 71: IMPURITY REFERENCE EP - LGC Ltd€¦ · (Anagrelide Impurity B) 1159977-03-3 A604740 2-Amino-5,6-dichloro-3(4H)-quinazoline Acetic Acid Hydrobromide (Anagrelide Impurity B) 1194434-39-3

71 20 Martin Ross Avenue North York, ON Canada, M3J 2K8

www.trc-canada.com [email protected] +1-416-665-9696

Chemical Name CAS Number Catalog Number

3,3’,5-Triiodo-L-thyronine 6893-02-3. T795380

Trimetazidine N-Carboxylic Acid Ethyl Ester 53531-01-4 T795530

Trimethoxy Dobutamine Hydrochloride 51062-14-7 T795675

2,3,4-Trimethoxybenzyl Alcohol 71989-96-3 T795690

1-(3,4,5-Trimethoxybenzyl)piperazine 52146-35-7 T796025

N,N,1-Trimethyl-3,3-diphenylallylamine Hydrochloride 55011-89-7 T796035

Tris(2-methylphenyl)phosphine 6163-58-2 T796355

rac-Trimethyl Ketoprofen (Mixture of (2’,3’4’) and (3’,4’,5’) Isomers) T796430

Trimipramine N1,N,N,2-tetramethylpropane-1,3-diamine T798945

Triphenylmethanol 76-84-6 T808950

N-Triphenylmethyl Irbesartan 886999-35-5 T808970

Triphenylphosphine Oxide 791-28-6 T808980

O,O',N-Tripropanal Ganciclovir 177216-32-9 T814010

(6α,11β,16α,17α)-(6'α,11'β,16'α,17'α)-17,17'-(Trithiodicarbonyl)bis[6,9-difluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)-androsta-1,4-dien-3-one

960071-64-1 T886430

Trityl Candesartan Cilexetil 170791-09-0 T887180

1-Tritylimidazole 15469-97-3 T888120

N-Trityl Losartan 133909-99-6 T888820

N-2 Trityl Olmesartan Medoxomil 1020157-01-0 T889420

Trometamoyloxy Fosfomycin-dimer 1262243-12-8 T892605

Tropic Acid 552-63-6 T892620

L-Tyrosine 60-18-4 T899975

Tyrosol 501-94-0 T947800

UK 14819 91147-46-5 U700570

Uracil 66-22-8 U801000

Urea 57-13-6 U822500

Ursocholic Acid 2955-27-3 U849900

3β-Ursodeoxycholic Acid 78919-26-3 U850005

Ursodeoxycholic Acid Methyl Ester 10538-55-3 U850050

D-Valacyclovir Hydrochloride 124832-28-6 V084995

L-Valine 2-Hydroxyethyl Ester Tosylate 86150-61-0 V094320

ent-Valsartan 137862-87-4 V095755

Valsartan Benzyl Ester 137863-20-8 V095760

Valsartan Methyl Ester 137863-17-3 V095765

Valsartan n-Propyl Impurity 952652-79-8 V095770

Venlafaxine Cyclic Impurity 93413-70-8 V120015

Vildagliptin Lactam 1789703-36-1 V305025

(+)-cis-Vincaminic Acid Ethyl Ester 40163-56-2 V314210

Page 72: IMPURITY REFERENCE EP - LGC Ltd€¦ · (Anagrelide Impurity B) 1159977-03-3 A604740 2-Amino-5,6-dichloro-3(4H)-quinazoline Acetic Acid Hydrobromide (Anagrelide Impurity B) 1194434-39-3

72 20 Martin Ross Avenue North York, ON Canada, M3J 2K8

www.trc-canada.com [email protected] +1-416-665-9696

Chemical Name CAS Number Catalog Number

5,6-trans-Vitamin D3, ~90% 22350-41-0 V676065

ent-Voriconazole 137234-63-0 V760005

(2,6-Xylyloxy)acetyl Lopinavir 943250-65-5 X750600

7-Xylosyltaxol 90332-66-4 X750770

Ziprasidone Amino Acid Sodium Salt (Ziprasidone Impurity C)

1798033-44-9 Z484995

Zolmitriptan N-Oxide 251451-30-6 Z639010

Zopiclone N-Oxide 43200-96-0 Z700510