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SERVICE AREAS• Pharmaceuticals

• Food and Agriculture

• Water Analysis

• Nutrients and dietary supplements

• Cosmetics

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TECHNIQUES OFFERED1) LCMSMS (2 nos)

2) GCMSMS (2nos)

3) HPLC – UV (2 nos)

4) HPLC – Fluorescence Detector

5) HPLC – PDA Detector (5 Nos) - Under Shipment

6) Dissolution Apparatus (2 nos)

7) GC-FID

8) GC – Head Space

9) ICP oes

10) UV- Spectro photometer

11) FTIR

11) Microbiology including BET (Bacterial Endotoxin)

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• Accreditations & Approvals

(License Copy on Next Slide)

NABL ACCREDITED (ISO 17025 : 2005)

FDA (MAHARASHTRA) APPROVED

US FDA REGISTERED

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PHARMACEUTICAL SERVICES

• Method Development• Method Validation• Impurity Profiling• Invitro Dissolution• Genotoxic Impurity • Elemental Impurities by ICP• Residual Solvents• Excipient Study• Cleaning Method Validation• Batch Release Testing• Investigations• Microbiology Kill Rate Studies • Endotoxin (BET) Testing

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• Method Development & VALIDATION• Analytical method validation and development services include:• Stability indicating assays• Forced degradation studies• Process impurity method development and validation• Analytical standard characterization• Pharmacokinetic, bioavailability, and bioequivalence method

development and validation• Technical consulting• Cleaning validation method development and validation• Peak Identification• USP method verification• Column equivalency studies

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• IMPURITY PROFILING• Organic impurities & inorganic impurities are estimated at

the Levels ranging from PPM to sub PPT levels using high sensitive techniques like mass spectroscopy.

• Process impurities are estimated using HPLC system

• Toxic residues are estimated with the aid of GC-MS/MS

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• INVITRO DISSOLUTIONS / BIO WAIVER STUDIES• Instrument : Waters 2695 HPLC with UV & Florescence Detector

• Software : EMPOWER

• Instrument : Agilent 1200 series HPLC with UV Detector

• Software : EZ Chrome

• Instrument : Electro- Lab 8 bowel Dissolution Tester with Auto Sampler

• CAPABILITIES • Method Validation For Kinetic Dissolution Test

• Comparative Dissolution Profile With Innovator

• Worked on dual detectors ie UV & Florescence

• Products • Drospirenone and Ethinyl Estradiol Tablets (3mg/0.03mg)

• Levonorgestrel and Ethinyl Estradiol Tablets (0.15mg/0.03mg)

• Desogestrel and Ethinyl Estradiol Tablets (150mcg/30mcg)

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• GENOTOXIC IMPURITIES

• CAPABILITIES • Method Development & Validation

• Methods developed• Ethyl Methyl Sulphonate Carbon Disulphide

• Sodium Azide Dimethyl Sulphate

• N-Chloro Succinamide Diethyl Sulphate

• 3 – Fluro -2-Methylaniline

• Carbendazim

• Thiophenate Methyl

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TECHNIQUE MAKELCMSMS (Triple Quad)2 NOS

AB SCIEX API 3200

LCMSMS (Triple Quad) Waters Quattra Micro

GCMSMS Thermo Fisher ITQ 1100

GCMSMS (Triple Quad) Agilent 7000

ELEMENTAL IMPURITIES

• Instrument : Perkin Elmer DV 7000 ICP oes

• Detection Limit : ppb level detection

• Matrix : Pharmaceutical samples as per USP chapter 232 & 233

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ELEMENTAL IMPURITIES

Lead Arsenic Mercury Cadmium Zinc

Aluminum Sodium Potassium Magnesium Manganese

Copper Gold Silver Platinum Palladium

Iridium Rhodium Ruthenium Osmium Molybdenum

Nickel Chromium Cobalt Barium Ruthenium

Vanadium Calcium Titanium

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• FOOD & AGRICULTURE PRODUCTS TESTED Bakery & Confectionary Edible Colours & Flavours Tea , Coffee & Cocoa Nuts Preservatives & Additives Fruit & Fruit Products Sugar & Confectionary Cereals & Pulses Nutritional Supplements Vegetable & Vegetable Products Infant Food Honey & Honey Products Oils & Fats Herbs, Spices & Condiments Animal Feeds Oil & Oil Seeds Alcoholic Beverages Non – Alcoholic Beverages

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CHEMICAL TESTING Pesticide Residue Preservatives Amino Acid Salts of Sorbic Acid PAH Brix Dioxins Total Soluble Solids Aflatoxins Total Acidity Mycotoxins Acid Insoluble Ash Moisture Fatty Acid Profile Brix Ash Protein Fat Carbohydrates Calories Dietary Fibre

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• PATHOGEN TESTS• Ecoli

• Salmonella

• S.aureas

• Total Plate Count

• Shigella

• Pseudomonas aeruginosa

• Listeria

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• Assay by Microbiology• Folic Acid

• Calcium Panthothenate

• Vitamin B12

Other Micro Biology Services :

1) BET Testing

2) Efficacy Studies

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STUDIES OFFERED

• Customer service is our passion - put us to the test!

• A short turnaround time for testing

• Good documentation

• Quick and helpful responses to your questions

• Reputation for attention to detail and meeting or exceeding client expectations

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DOCTORS ANALYTICAL LABORATORIES PVT LTD

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THANK YOU