m1203, maleic acid, nf€¦ · m1203, maleic acid, nf. dear customer, ... fumaric acid 1.0 % malic...

Not appropriate for regulatory submission. Please visit www.spectrumchemical.com or contact Tech Services for the most up‐to‐date information contained in this information package.

Spectrum Chemical Mfg Corp 769 Jersey Avenue New Brunswick, NJ 08901 Phone 732.214.1300

Ver4.04 30.September.2019

Scientific Documentation M1203, Maleic Acid, NF

Dear Customer,

Thank you for your interest in Spectrum’s quality products and services.

Spectrum has been proudly serving the scientific community for over 45 years. It is our mission to manufacture and distribute fine chemicals and laboratory products with Quality and delivery you can count on every time.

To accomplish our mission, Spectrum utilizes our sourcing leverage and supplier qualification expertise in offering one of the industry’s most comprehensive line of fine chemical products under one brand, in packaging configurations designed to meet your research and production requirements. Our product grades include: USP, NF, BP, EP, JP, FCC, ACS, KSA, Reagent grade, as well as DEA controlled substances. We operate facilities in the United States on the East Coast, West Coast, as well as in Shanghai, China in order to provide the best logistical support for our customers.

At Spectrum, Quality is priority number one. Suppliers with the best qualifications are preferred and we employ full-functioning in-house analytical laboratories at each of our facilities. Our facilities and systems are USFDA registered and ISO certified. We frequently host customer audits and cherish opportunities for improvements. Quality is engrained into our culture. Quality is priority number one.

In the following pages, we have designed and prepared documented scientific information to aid you in your initial qualification or your continual use of our products. Please do not hesitate to contact us if further information or the most up-to-date documentation is desired from any of the covered areas.

We appreciate your business and we look forward to hearing from you.

Sincerely,

Michael Dang Director, Quality Systems & GMP Compliance [email protected]

30.September.2019

M1203, Maleic Acid, NF

Table of Contents

Product Specification

Safety Data Sheet (SDS)

Certification of Quality Management System (QMS)

Certification of current Good Manufacturing Practices (cGMP)

Product BSE/TSE Statement

Product Allergen Statement

Product Aflatoxin Statement

Product Certificate of Analysis Sample(s)

General Label Information – Sample Label

General Lot Numbering System Guidance

Stability – Shelf Life Guidance

Specification for Maleic Acid, NF (M1203)

Item Number M1203

Item Maleic Acid, NF

CAS Number 110-16-7

Molecular Formula C4H4O4

Molecular Weight 116.07

MDL Number

Synonyms cis-Butenedioic Acid ; Toxilic Acid

Test SpecificationMin Max

ASSAY (ANHYDROUS BASIS) 98.0 102.0 %

FUMARIC ACID 1.0 %

MALIC ACID 0.5 %

IRON (Fe) 5 ppm

ELEMENTAL IMPURITIES AS REPORTED

RESIDUE ON IGNITION 0.1 %

WATER DETERMINATION 0.5 %

IDENTIFICATION (A) Matches Infared spectrum

IDENTIFICATION (B) Matches standard solutionHLPC peak

EXPIRATION DATE

MANUFACTURE DATE

APPEARANCE

RESIDUAL SOLVENTS AS REPORTED

SAFETY DATA SHEETPreparation Date: 01/23/2015 Revision date 10/1/2019 Revision Number: G2

1. IDENTIFICATIONProduct identifier

Product code: M1203Product Name: Maleic Acid, NF

Other means of identification Synonyms: (2)-Butenedioic Acid (2Z); (Z)-Butenedioic Acid

cis-Butenedioic Acidcis-1,2-Ethylenedicarboxylic acid1,2-Ethylenedicarboxylic acid, (Z)Butenedioic acid, (Z)-Maleinic acidMalenic acid

CAS #: 110-16-7RTECS # OM9625000CI#: Not available

Recommended use of the chemical and restrictions on use Recommended use: In inorganic synthesis. Chemical intermediate. Manufacture of resins. Preservative

for oils and fats. Dyeing and finishing of cotton, wool and silk.Uses advised against No information available

Supplier: Spectrum Chemical Mfg. Corp14422 South San Pedro St.Gardena, CA 90248(310) 516-8000

Order Online At: https://www.spectrumchemical.com Emergency telephone number Chemtrec 1-800-424-9300Contact Person: Tom Tyner (USA - West Coast)Contact Person: Ibad Tirmiz (USA - East Coast)

2. HAZARDS IDENTIFICATION

Classification

This chemical is considered hazardous by the 2012 OSHA Hazard Communication Standard (29 CFR 1910.1200)

Considered a dangerous substance or mixture according to the Globally Harmonized System (GHS)

Acute toxicity - Oral Category 4Acute toxicity - Dermal Category 4Skin corrosion/irritation Category 2Serious eye damage/eye irritation Category 1Skin sensitization Category 1Specific target organ toxicity (single exposure) Category 3

Product code: M1203 Product name: Maleic Acid, NF Page 1 / 12

Label elements

Hazards not otherwise classified (HNOC) Not Applicable

Other hazards Not available

Precautionary Statements - PreventionWash face, hands and any exposed skin thoroughly after handlingDo not eat, drink or smoke when using this productWear protective gloves/protective clothing/eye protection/face protectionAvoid breathing dustContaminated work clothing must not be allowed out of the workplaceUse only outdoors or in a well-ventilated area

Precautionary Statements - Response

IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.Immediately call a POISON CENTER or physician.IF ON SKIN: Wash with plenty of waterCall a POISON CENTER or physician if you feel unwellTake off contaminated clothing and wash it before reuseIf skin irritation or rash occurs: Get medical attentionIF INHALED: Remove person to fresh air and keep comfortable for breathing. Call a POISON CENTER or physician if you feelunwell.IF SWALLOWED: Call a POISON CENTER or physician if you feel unwellRinse mouth

Precautionary Statements - StorageStore in a well-ventilated place. Keep container tightly closedStore locked up

Precautionary Statements - DisposalDispose of contents and container to an approved waste disposal plant in accordance with local, regional, national andinternational regulations as applicable

3. COMPOSITION/INFORMATION ON INGREDIENTS

Danger

Hazard statementsHarmful if swallowed or in contact with skinCauses skin irritationCauses serious eye damageMay cause an allergic skin reactionMay cause respiratory irritation


Component CAS No Weight-%Maleic Acid 110-16-7 100

4. FIRST AID MEASURES

First aid measures

General Advice: National Capital Poison Center in the United States can provide assistance if youhave a poison emergency and need to talk to a poison specialist. Call1-800-222-1222.

Skin Contact: Wash off immediately with soap and plenty of water removing all contaminated clothing andshoes. Get medical attention. If skin irritation persists, call a physician.

Eye Contact: Flush eyes with water for 15 minutes. Immediate medical attention is required. Call aphysician immediately.

Inhalation: Move to fresh air. If not breathing, give artificial respiration. If breathing is difficult, giveoxygen. Get medical attention.

Ingestion: Do not induce vomiting without medical advice. Never give anything by mouth to anunconscious person. Obtain medical attention.

Most important symptoms and effects, both acute and delayed

Symptoms Causes skin irritationModerate skin irritationMay cause eye damageMay cause an allergic skin reaction

Indication of any immediate medical attention and special treatment needed

Notes to Physician: Treat symptomatically.

Protection of first-aidersFirst-Aid Providers: Avoid exposure to blood or body fluids. Wear gloves and other necessary protective clothing. Dispose ofcontaminated clothing and equipment as bio-hazardous waste.

5. FIRE-FIGHTING MEASURES

Extinguishing Media Suitable Extinguishing Media: Carbon dioxide (CO2). Dry chemical. Water spray mist or

foam.

Unsuitable Extinguishing Media: No information available.

Specific hazards arising from the chemical

Hazardous combustion products Carbon Monoxide, Carbon Dioxide.

Specific hazards May be combustible at high temperatures.

Special Protective Actions for Firefighters

Specific Methods: No information available

Special Protective Equipment for Firefighters: As in any fire, wear self-contained breathing apparatuspressure-demand, MSHA/NIOSH (approved or equivalent)


and full protective gear

7. HANDLING AND STORAGE

Precautions for safe handling

Technical Measures/Precautions:Provide sufficient air exchange and/or exhaust in work rooms. Avoid dust formation. Keep away from incompatiblematerials.

Safe Handling Advice:Wear personal protective equipment. Avoid contact with skin, eyes and clothing. Keep away from heat andsources of ignition. Avoid dust formation. Do not ingest. Do not breathe vapors/dust. Handle in accordance withgood industrial hygiene and safety practice.

Conditions for safe storage, including any incompatibilities

Technical Measures/Storage Conditions:Keep container tightly closed in a dry and well-ventilated place. Store at room temperature in the originalcontainer. Store away from incompatible materials. Protect from light. Sensitive to light. Store in light-resistantcontainers.

Incompatible Materials:Oxidizing agents

8. EXPOSURE CONTROLS/PERSONAL PROTECTIONControl parameters

National occupational exposure limits

United States

Component CAS No OSHA NIOSH ACGIH AIHA WEELMaleic Acid 110-16-7 None None None None

Canada

Component CAS No Canada - Alberta Canada - BritishColumbia

Canada - Ontario Canada - Quebec

Maleic Acid 110-16-7 None None None None

6. ACCIDENTAL RELEASE MEASURES

Personal precautions, protective equipment and emergency procedures

Personal Precautions: Ensure adequate ventilation. Keep people away from and upwind of spill/leak. Do not touchdamaged containers or spilled material unless wearing appropriate protective clothing.Avoid contact with skin, eyes and clothing. Use personal protective equipment. Avoid dustformation. Remove all sources of ignition.

Environmental precautions Prevent further leakage or spillage if safe to do so. Prevent product from enteringdrains. Prevent entry into waterways, sewers, basements or confined areas.

Methods and material for containment and cleaning up

Methods for containment Stop leak if you can do it without risk. Cover with plastic sheet to preventspreading.

Methods for cleaning up Sweep up and shovel into suitable containers for disposal. Clean contaminatedsurface thoroughly.


Australia and Mexico

Component CAS No Australia MexicoMaleic Acid 110-16-7 None None

Appropriate engineering controls

Engineering measures to reduce exposure: Ensure adequate ventilation. Use process enclosures,local exhaust ventilation, or other engineering controls tokeep airborne levels below recommended exposure limits.If user operations generate dust, fume or mist, useventilation to keep exposure to airborne contaminantsbelow the exposure limit.

Individual protection measures, such as personal protective equipment

Personal Protective Equipment

Eye protection: Goggles or Safety glasses with side-shields.

Skin and body protection: Long sleeved clothingChemical resistant apronGloves

Respiratory protection: Effective dust mask. or. Wear respirator with dust filter.

Hygiene measures: Avoid contact with skin, eyes and clothing. Wash hands before breaks andimmediately after handling the product When using, do not eat, drink or smoke.

9. PHYSICAL AND CHEMICAL PROPERTIES

Physical state:Solid

Appearance:Crystals. Crystalline powder.

Color:White.

Odor:Slight. Acidulous.

TasteCharacteristic. Repulsive. Astringent.

FormulaC4H4O4

Molecular/Formula weight (g/mole):116.08

Flammability (solid, gas)no data available

Flashpoint (°C/°F):138°C/280°F

Flash Point Tested according to:Not available

Autoignition Temperature (°C/°F):No information available

Lower Explosion Limit (%):No information available

Upper Explosion Limit (%):No information available

Melting point/range(°C/°F):138.5°C/281.3°F

Decomposition temperature(°C/°F):135°C/275°F

Boiling point/range(°C/°F):No information available

Bulk density:No information available

Density (g/cm3):No information available

Specific gravity:1.59

pHNo information available

Vapor pressure @ 20°C (kPa):4x10^-3 Pa/25°C

Evaporation rate:No information available

Vapor density:4.0

VOC content (g/L):No information available

Odor threshold (ppm):No information available


Partition coefficient(n-octanol/water):

10. STABILITY AND REACTIVITYReactivity Reactive with oxidizing agentsReacts with strong basesReactive with strong reducing agents

Chemical stability

Stability: Stable under recommended storage conditions.

Possibility of Hazardous Reactions: Hazardous polymerization does not occur

Conditions to avoid: Heat. Exposure to light. Incompatible materials.

Incompatible Materials: Oxidizing agents

Hazardous decomposition products:

Carbon oxides. When heated to decomposition it emits acrid smoke and irritatingfumes.

Other Information Corrosivity: No information available

Special Remarks on Corrosivity: No information available

11. TOXICOLOGICAL INFORMATION

Information on likely routes of exposure

Principal Routes of Exposure:Ingestion. Inhalation. Skin.

Acute Toxicity

Component Information

Maleic AcidCAS No 110-16-7

LD50/oral/rat = 708 mg/kg Oral LD50 RatLD50/oral/mouse = No information availableLD50/dermal/rabbit = 1560mg/kgDermal LD50RabbitLD50/dermal/rat = No information availableLC50/inhalation/rat = >720 mg/m3 Inhalation LC50 Rat 1 hLC50/inhalation/mouse = No information availableOther LD50 or LC50information = No information available

-0.48 Viscosity:No information available

Miscibility:No information available

Solubility:Soluble in WaterFreely soluble in alcoholSoluble in AcetoneSoluble in glacial Acetic acidSlightly soluble in EtherPractically insoluble in BenzeneInsoluble in Chloroform


Product Information

LD50/oral/rat =Value - Acute Toxicity = 708 mg/kg

LD50/oral/mouse =Value - Acute Tox = No information available

LD50/dermal/rabbitValue - Acute Toxicity = 1560 mg/kg

LD50/dermal/ratVALUE - Acute Tox = No information available

LC50/inhalation/ratVALUE-Vapor = No information availableVALUE-Gas = No information availableVALUE-Dust/Mist = >720 mg/m³ (1-hr)

LC50/Inhalation/mouseVALUE-Vapor = No information availableVALUE - Gas = No information availableVALUE - Dust/Mist = No information available

Symptoms

Skin Contact: Harmful in contact with skin. Causes skin irritation. May cause severe irritation andpossible burns if skin is wet.

Eye Contact: Severe eye irritation. Possible eye damage.

Inhalation Irritating to respiratory system. Symptoms may include coughing and wheezing,and shortness of breath. May cause sore throat.

Ingestion Harmful if swallowed. Causes digestive (gastrointestinal) tract irritation. May affectthe kidneys.

Aspiration hazard No information available.

Delayed and immediate effects as well as chronic effects from short and long-term exposure

Chronic Toxicity Prolonged or repeated ingestion may affect the kidneys. Prolonged or repeatedinhalation can cause respiratory tract irritation, bronchospasm, chronic bronchitiswith coughing, wheezing, phlegm and/or shortness of breath. Skin: Sensitizer.May cause allergic skin reaction (allergic contact dermatitis).

Sensitization: May cause sensitization by skin contact.

Mutagenic Effects: No information available

Carcinogenic effects: Not considered carcinogenic.

Component CAS No IARC ACGIH -Carcinogens

NTP OSHA HCS -Carcinogens

Australia -Notifiable

CarcinogenicSubstances

Australia -Prohibited

CarcinogenicSubstances

Maleic Acid 110-16-7 Not listed Not listed Not listed Not listed Not listed Not listed


ACGIH (American Conference of Governmental Industrial Hygienists)

IARC (International Agency for Research on Cancer)

NTP (National Toxicology Program)

OSHA (Occupational Safety and Health Administration of the US Department of Labor)

Reproductive toxicity No data is available

Reproductive Effects: No information availableDevelopmental Effects: No information availableTeratogenic Effects: No information available

Specific Target Organ Toxicity

STOT - single exposure respiratory system.STOT - repeated exposure No information available.Target Organs: Kidneys. Lungs. Respiratory system.

12. ECOLOGICAL INFORMATION

Ecotoxicity

Ecotoxicity effects: No data available.

Maleic Acid - 110-16-7Fish LC50: =5mg/L (96h, Pimephales promelas)Crustacea EC50: 250 - 400mg/L (48h, Daphnia magna)

Persistence and degradability: No information available

Bioaccumulative potential: No information available.

Mobility in soil No information availableOther adverse effects No information available.

13. DISPOSAL CONSIDERATIONS

Disposal Methods

Waste from residues / unused products:Waste must be disposed of in accordance with Federal, State and Local regulation.

Contaminated packaging:Empty containers should be taken for local recycling, recovery or waste disposal

Component CAS No RCRA - F SeriesWastes

RCRA - K SeriesWastes

RCRA - P SeriesWastes

RCRA - U SeriesWastes

Maleic Acid 110-16-7 None None None None

14. TRANSPORT INFORMATION

DOTUN-No: Not RegulatedProper Shipping Name: Not regulated (although listed Table 1 to Appendix A - Hazardous Substances

Other


Than Radionuclides, it is not regulated for transport in sold quantities, which arebelow the Reportable Quantity (RQ))

Hazard Class No information availableSubsidiary Class No information availablePacking group: No information availableEmergency Response GuideNumber

No information available

Marine Pollutant No data availableDOT RQ (lbs): 5000 lbs/2270 kgSpecial Provisions No Information availableSymbol(s): No information availableDescription: No information available

TDG (Canada)UN-No: Not RegulatedProper Shipping Name: No information availableHazard Class No information availableSubsidiary Risk: No information availablePacking Group: No information availableMarine Pollutant No Information availableDescription: No information available

ADRUN Number Not regulatedProper Shipping Name: No information availableTransport hazard class(es) No information availablePacking group No information availableSubsidiary Risk: No information available

IMDGUN-No: Not RegulatedProper Shipping Name: No information availableHazard Class: No information availableSubsidiary Risk: No information availablePacking Group: No information availableMarine Pollutant No information available

RIDUN Number Not RegulatedProper Shipping Name: No information availableTransport hazard class(es) No information availableSubsidiary Risk: No information availablePacking group No information available

ICAO (air)UN-No: Not RegulatedProper Shipping Name: No information availableHazard Class No information availableSubsidiary Risk: No information availablePacking Group: No information available

IATAUN Number Not RegulatedProper Shipping Name: No information availableTransport hazard class(es) No information availableSubsidiary Risk: No information availablePacking group No information availablePrecautionary Statements -Response

No information available


Special Provisions No information available

15. REGULATORY INFORMATION

International Inventories

Component CAS No U.S. TSCA KOREA KECL Philippines(PICCS)

Japan ENCS China IECSC Australia(AICS)

EINECS-No.

Maleic Acid 110-16-7 PresentACTIVE

PresentKE-13657

Present Present(2)-1100

Present Present Present203-742-5

U.S. Regulations

Maleic AcidMassachusetts RTK: PresentNew Jersey RTK Hazardous Substance List: 1151New Jersey - Discharge Prevention - List of Hazardous Substances: PresentPennsylvania RTK: Environmental hazardPennsylvania RTK - Environmental Hazard List PresentNew York Release Reporting - List of Hazardous Substances:5000 lb RQ100 lb RQLouisana Reportable Quantity List for Pollutants: ListedCalifornia Directors List of Hazardous Substances: Present

California Prop. 65: Safe Drinking Water and Toxic Enforcement Act of 1986.

Chemicals Known to the State of California to Cause Cancer:This product does not contain a chemical requiring a warning under California Prop. 65. (See table below)

Chemicals Known to the State of California to Cause Reproductive Toxicity:This product does not contain a chemical requiring a warning under California Prop. 65. (See table below)

Component CAS No Carcinogen Developmental Toxicity MaleReproductiveToxicity

FemaleReproductiveToxicity:

Maleic Acid 110-16-7 Not Listed Not Listed Not Listed Not Listed

CERCLA/SARA

Component CAS No CERCLA -Hazardous

Substances andtheir Reportable

Quantities

Section 302ExtremelyHazardousSubstancesand TPQs

Section 302ExtremelyHazardous

Substances andRQs

Section 313 -Chemical Category

Section 313 -Reporting

de minimis

Maleic Acid 110-16-7 5000 lb final RQ2270 kg final RQ

None None None None

U.S. TSCA

Component CAS No TSCA Section 5(a)2 - ChemicalsWith Significant New Use Rules(SNURS)

TSCA 8(d) -Health and SafetyReporting

Maleic Acid 110-16-7 Not Applicable Not Applicable

Canada

WHIMIS 2015 - GHS Classifications

WHMIS 2015 Hazard ClassificationInformation:

The WHMIS 2015 classification of this product has not been validated or reviewed yet.


Canada Hazardous Products Regulation This product has not been classified according to the hazard criteria of the HPR (HazardousProducts Regulation) and the SDS contains all of the information required by the HPR

DSL/NDSL

Component CAS No Canada (DSL) Canada (NDSL)Maleic Acid 110-16-7 Present Not Listed

Component CAS No CEPA Schedule I - Toxic SubstancesMaleic Acid 110-16-7 Not listedComponent CAS No CEPA - 2010 Greenhouse Gases Subject

to Mandatory ReportingMaleic Acid 110-16-7 Not listed

EU Classification

EU GHS - SV - CLP 1272/2008

Component CAS No EU GHS - SV - CLP (1272/2008)Maleic Acid 110-16-7 Acute toxicity - Oral - Acute Tox. 4:

H302 Harmful if swallowed. (Minimumclassification); Skin corrosion/irritation

- Skin Irrit. 2: H315 Causes skinirritation.; Serious Eye Damage/EyeIrritation - Eye Irrit. 2: H319 Causes

serious eye irritation.; Skin sensitizers- Skin Sens. 1: H317 May cause

allergic skin reaction.; Specific targetorgan toxicity - Single exposure -

STOT SE 3: H335 May causerespiratory irritation.607-095-00-3

Skin sensitizers - Skin Sens. 1: H317May cause allergic skin reaction. (C >=

0.1 %)607-095-00-3

EU - CLP (1272/2008)

R-phrase(s)R22 - Harmful if swallowedR43 - May cause sensitization by skin contactR36/37/38 - Irritating to eyes, respiratory system and skin

S -phrase(s)S 2 - Keep out of the reach of children.S24 - Avoid contact with skinS26 - In case of contact with eyes, rinse immediately with plenty of water and seek medical adviceS28 - After contact with skin, wash immediately with plenty of waterS37 - Wear suitable glovesS46 - If swallowed, seek medical advice immediately and show this container or label

Component CAS No Classification ConcentrationLimits:

Safety Phrases

Maleic Acid 110-16-7 Xn; R22Xi; R36/37/38R43

0.1%<=C R43 S2 S24 S26 S28 S37S46

The product is classified in accordance with Annex VI to Directive 67/548/EEC


Indication of danger:Xn - HarmfulXi - Irritant

16. OTHER INFORMATION

Preparation Date: 01/23/2015Revision date 10/1/2019Prepared by: Sonia Owen

Disclaimer: All chemicals may pose unknown hazards and should be used with caution. ThisSafety Data Sheet (SDS) applies only to the material as packaged. If this productis combined with other materials, deteriorates, or becomes contaminated, it maypose hazards not mentioned in this SDS. The physical properties reported in thisSDS are obtained from the literature and do not constitute product specifications.Information contained herein does not constitute a warranty, whether expressed orimplied, as to the safety, merchantability or fitness of the goods for a particularpurpose. Spectrum Chemicals & Laboratory Products, Inc. assumes noresponsibility for results obtained or for incidental or consequential damages,including lost profits, arising from the use of these data. No warranty againstinfringement of any patent, copyright or trademark is made or implied. It shall bethe user's responsibility to develop proper methods of handling and personalprotection based on the actual conditions of use. While this SDS is based ontechnical data judged to be reliable, Spectrum assumes no responsibility for thecompleteness or accuracy of the information contained herein.

End of Safety Data Sheet


C O R P O R A T E H E A D Q U A R T E R S

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New Brunswick, NJ 08901

PHONE 732.214.1300

FAX 732.246.7132

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w w w . s p e c t r u m c h e m i c a l . c o m

January 08, 2019 Certification of Compliance with current Good Manufacturing Practices Dear Valued Customer: Spectrum Chemical Mfg Corp certifies that our USP, NF, FCC, EP, BP, JP, and food grade products are produced, processed, packaged and held in compliance with current Good Manufacturing Practices (cGMP) in accordance with the applicable parts of 21 CFR, parts 210 and 211 and parts 110 and 111 of the Code of Federal Regulations, respectively. Spectrum is an FDA registered and inspected Drug Establishment. Our United States Food and Drug Administration (USFDA) Registration numbers are as follows: Spectrum Gardena, California: 2020632 Spectrum New Brunswick, New Jersey: 2246824 Thank you for your interest in Spectrum products. Please feel free to contact me at 310-516-8000, extension 5610 or via email at [email protected] if I may be of further assistance. Sincerely,

Michael Dang Director, Quality Systems & GMP Compliance

September 30, 2019

Certification of Compliance with current Good Manufacturing Practices

Dear Valued Customer:

Spectrum Chemical Mfg Corp certifies that the following product(s) is produced, processed, packaged and held in compliance with current Good Manufacturing Practices (cGMP) in accordance with the applicable parts of 21 CFR, parts 210 and 211 of the Code of Federal Regulations.

Catalog Number Product Name M1203 Maleic Acid, NF

Spectrum is an FDA registered and inspected Drug Establishment. Our United States Food and Drug Administration (USFDA) Registration numbers are as follows:

Spectrum-Gardena, CA: 2020632 Spectrum-New Brunswick, NJ: 2246824

Thank you for your interest in Spectrum products. If we may be of further assistance, please feel free to contact the Quality Assurance department at 310-516-8000 or via email at [email protected]

Sincerely,

Oralia Chavez Quality Assurance Specialist

September 27, 2019 Re: Maleic Acid, NF- M1203 To Whom It May Concern: Thank you for your interest in Spectrum high quality chemicals. We at Spectrum Chemical Mfr. Corp. understand the concern regarding Bovine Spongiform Encephalopathy (BSE). Please be assured that the chemical Maleic Acid, NF- M1203 is BSE/TSE free. If you have any further questions, please contact Tech Services at (310) 516- 8000 Extension 5471, or by email at [email protected]. Sincerely, Darlene Dagdag-Lyudmirskiy Technical Services Spectrum Chemical Mfr. Corp. This document has been produced electronically and is valid without a signature

September 27, 2019 Re: Maleic Acid, NF- M1203 To Whom It May Concern: Thank you for your interest in Spectrum high quality chemicals. We at Spectrum Chemical Mfr. Corp. understand the concern regarding the presence of allergens in raw materials. Please be assured that the following chemical does not contain (Milk; Egg; Fish; Shellfish; Sulfur dioxide and sulfites at concentrations of more than 10 mg/kg or 10 mg/liter expressed as SO2; Lupin; Tree nuts; Mollusks; Wheat; Peanuts; Soy; Cereals containing Gluten; Celery; Mustard; Sesame Seed). Maleic Acid, NF- M1203

If you have any further questions, please contact Tech Services at (310) 516- 8000 Extension 5471, or by email at [email protected]. Sincerely, Darlene Dagdag-Lyudmirskiy Technical Services Spectrum Chemical Mfr. Corp. This document has been produced electronically and is valid without a signature

September 27, 2019 Re: Maleic Acid, NF- M1203 To Whom It May Concern: Thank you for your interest in Spectrum high quality chemicals. We at Spectrum Chemical Mfg. Corp. understand the concern regarding Aflatoxins in raw materials. To the best of our knowledge, the product listed below is not contaminated with Aflatoxins. Aflatoxins are not used in production. The following product does not come in contact with Aflatoxins at any stage of production. Maleic Acid, NF- M1203 If you have any further questions, please contact Tech Services at (310) 516- 8000 Extension 5471, or by email at [email protected]. Sincerely, Darlene Dagdag-Lyudmirskiy Technical Services Spectrum Chemical Mfr. Corp. This document has been produced electronically and is valid without a signature

Certificate Of Analysis

Item Number M1203 Lot Number 2IC0205

Item Maleic Acid, NF

CAS Number 110-16-7

Molecular Formula C4H4O4 Molecular Weight 116.07

Test Specification Resultmin max

99.0 101.0 % 99.6 %

CLEAR AND NOTMORE COLOREDTHAN REFERENCE

CLEAR AND NOTMORE COLORED

THAN REFERENCE

1.5 % <1.5 %

5 ppm <5 ppm

AS REPORTED COMPLIES WITHSTANDARD

0.1 % <0.1 %

2.0 % 0.04 %

2 <2

PRINCIPLE SPOTCORRESPONDS TOSTANDARD A

PRINCIPLE SPOTCORRESPONDS TO

STANDARD A

SPECTRUMMATCHESREFERENCE

SPECTRUMMATCHES

REFERENCE

01-MAR-2021

01-MAR-2019

WHITECRYSTALLINE

POWDER

AS REPORTED NO RESIDUALSOLVENTS USED

Spectrum Chemical Mfg Corp

755 Jersey Avenue

New Brunswick 08901 NJ

All pharmaceutical ingredients are tested using current edition of applicable pharmacopeia.

Read and understand label and SDS before handling any chemicals. All Spectrum's chemicals are for manufacturing, processing,repacking or research purposes by experienced personnel only. It is the customer's responsibility to provide adequate hazardousmaterial training and ensure that appropriate Personal Protective Equipment (PPE) is used before handling any chemical.

The Elemental Impurities standards implemented by USP and other Pharmaceutical Compendia reflect a growing understandingof the toxicology of trace levels of elemental impurities that can remain in drug substances originating from either raw materials ormanufacturing processes. Identifying and quantifying impurities can be critical to predicting the best possible patient outcomes.Elemental Impurities has been a requirement of all products meeting USP/NF, EP and BP monographs since January 1, 2018.More information can be found in USP sections <232> Elemental Impurities – Limits and <233> Elemental Impurities –Procedures. Data for drug substances furnished by Spectrum Chemical Mfg. Corp can be used to ensure that patient dailyexposures by oral administration to the selected elements are not exceeded in the formulation of pharmaceutical products.

*49452M1203062233lva*

www.SpectrumChemical.com

Exp.

Dat

e: 0

3-31

-202

1

Chemical Emergency: (800)424-9300

M1203 12 KGMaleic Acid(cis-Butenedioic Acid)

NFCAS 110-16-7

CAUTION: For manufacturing, processing or repacking. Read and understand the label and Safety Data Sheet (SDS) prior to use.

DANGER• Causes serious eye damage • Causes skin irritation • May cause respiratory irritation • Harmful if swallowed or in contact with skin.• Do not eat, drink or smoke when using this product • Wear protective gloves, protective clothing, eye protection, face protection • Avoid breathing dust • Use only outdoors or in a well-ventilated area • Wash face, hands and any exposed skin thoroughly after handling. FIRST AID: Immediately call a POISON CENTER or physician. IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. IF ON SKIN: Wash with plenty of water. Take off contaminated clothing and wash it before reuse. If skin irritation occurs: Get medical attention. IF INHALED: Remove person to fresh air and keep comfortable for breathing. IF SWALLOWED: Rinse mouth.

KEEP FROM CHILDREN W 4/I7GHS A Lot No. 062233

C4H4O4 F.W. 116.07

Assay (Anhydrous Basis) ...........................98.0-102.0%MAXIMUM LIMITS

Fumaric Acid .......................................................... 1.0%Malic Acid .............................................................. 0.5%Iron ...................................................................... 5 ppmElemental Impurities .................................... As reportedResidue on Ignition ................................................ 0.1%Water Determination .............................................. 0.5%Residual Solvents ....................................... To pass test

LIGHT SENSITIVE: Keep tightly closed in light-resistant containers. Store at room temperature.

WARNING: Cancer and Reproductive Harm- www.P65Warnings.ca.gov

DOT: UN3261, Corrosive solid, acidic, organic, n.o.s. (maleic acid), 8, PG III

XxAa

W w

SPECTRUM CHEMICAL MFG. CORP. Gardena, CA 90248 • New Brunswick, NJ 08901

Empirical Formula, Formula Weight and Technical Specifications Panel

Expiration Information

Lot Number

Kosher Certified by Kosher Supervision of America (KSA).

Bar CodeGHS Hazard PictogramsWarning, Safety Data and Precautionary InformationProduct Catalog NumberItem Name, Form, Grade

Size/Quantity

Chemical Abstracts Service (CAS) Registry Number

Caution Information

DOT Shipping Information

Toll-Free 24-Hour Chemical Emergency Telephone Number

B

K

D

A

I

C

H

F

G

L

E

J

YELLOW: Oxidizer

RED: Flammable

GREEN: General Storage

BLUE: Health Hazard

WHITE: Corrosive

Storage Color Band

This color-coded band indicates the hazard most likely to be posed by that material under storage conditions. The criteria used to assign band colors have been established by the Storage Code working group of the Society for Chemical Hazard Communication (SCHC). It is recommended that like colors be stored together, unless otherwise stated, based on the color codes indicated to the right. However, it is the responsibility of the customer to check with their local fire department for possible conflicts with our recommendations when storing hazardous chemicals.

O

Label Legend

M

N

The Spectrum label presents technical and safety information in an easily understood format. Our technical specialists stay abreast of the latest requirements of the Globally Harmonized System for Classification and Labelling of Chemicals (GHS), as well as the Occupational Safety and Health Administration (OSHA), the Food and Drug Administration (FDA) and other government regulatory agencies in order to ensure compliance, accuracy and concise hazard communication.

G

D

J

H

C

B

E

F

KA

M

OL

I

Spectrum Chemical Mfg Corp

Corporate Headquarters: West Coast Facility:

769 Jersey Ave. 14422 S. San Pedro St.

New Brunswick, NJ 08901 Gardena, CA 90248

732.214.1300 310.516.8000

Label Information

C O R P O R A T E H E A D Q U A R T E R S

769 Jersey Avenue

New Brunswick, NJ 08901

PHONE 732.214.1300

FAX 732.246.7132

A N I S O 90 0 1 :2 0 15 RE G IS T E RE D COM P A NY

W E S T C O A S T F A C I L I T Y

14422 South San Pedro Street

Gardena, California 90248

PHONE 310.516.8000

FAX 310.516.9843

w w w . s p e c t r u m c h e m i c a l . c o m

February 1, 2019 RE: Lot Numbering System Dear Valued Customer: This letter is to inform you of Spectrum Chemicals and Laboratory Products’ Lot Numbering System. The system is based on an alpha-numerical sequence which provides the month, year and location of production. The lot numbering system utilized until 2010 is a sequence of six characters, two letters followed by four numbers. The first letter represents the year, for example, Y denotes 2009 and Z denotes 2010. The second letter represents the month and site, for example, A-L denotes January through December at Spectrum’s Gardena, CA facility, while M-X denotes January through December at the New Brunswick, NJ facility. The following four numbers are sequentially assigned.

Example: ZI0928 = The 928th material produced in California in September 2010 The lot numbering system utilized for 2011 and forward, is a sequence of seven characters. The first character, a number, represents the production facility: 1 = Gardena, CA Facility 2 = New Brunswick, NJ Facility 3 = China Facility 4 = Pharmacy, NJ Facility The second character, a letter, represents the year. For example, A denotes 2011 and B denotes 2012. The third character, a letter, represents the month, with A denoting January and L denoting December. The following four numbers are sequentially assigned.

Example: 2AA0706 = The 706th material produced in New Jersey in January 2011 Thank you for your interest with Spectrum products. Please feel free to contact us at 310-516-8000 or via email at [email protected] if we may be of further assistance.

Sincerely,

Howard Lau, Quality Assurance Specialist

30.September.2019

Stability – Shelf Life Guidance Product Covered: M1203, Maleic Acid, NF

Spectrum Chemical’s manufacturing partner has assigned the following shelf life guidance for the product listed above. The product, M1203, Maleic Acid, NF, is assigned a 24 months shelf life from date of manufacturing. The quality and integrity of the chemical depends on the handling and storage conditions. Please refer to the Safety Data Sheet for proper storage and handling procedures. Adan R. Hernandez Quality Control Manager

Corporate Headquarters 769 Jersey Avenue New Brunswick, NJ 08901-3605

m1203, maleic acid, nf€¦ · m1203, maleic acid, nf. dear customer, ... fumaric acid 1.0 % malic...

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