1/13/2014

1
SERVICE AREAS
•
•
•
•
•

Pharmaceuticals
Food and Agriculture
Water Analysis
Nutrients and dietary supplements
Cosmetics

...
TECHNIQUES OFFERED
1) LCMSMS (2 nos)

2) GCMSMS (2nos)
3) HPLC – UV (2 nos)
4) HPLC – Fluorescence Detector
5) HPLC – PDA ...
• Accreditations & Approvals
NABL ACCREDITED (ISO 17025 : 2005)
FDA (MAHARASHTRA) APPROVED
US FDA REGISTERED

(License Cop...
1/13/2014

5
1/13/2014

6
1/13/2014

7
1/13/2014

8
PHARMACEUTICAL SERVICES
•
•
•
•
•
•
•
•
•
•
•
•
•

Method Development
Method Validation
Impurity Profiling
Invitro Dissolu...
• Method Development & VALIDATION
•
•
•
•
•
•
•
•
•
•
•

Analytical method validation and development services include:
St...
• IMPURITY PROFILING
• Organic impurities & inorganic impurities are estimated at
the Levels ranging from PPM to sub PPT l...
• INVITRO DISSOLUTIONS / BIO WAIVER STUDIES
•
•
•
•
•

Instrument : Waters 2695 HPLC with UV & Florescence Detector
Softwa...
• GENOTOXIC IMPURITIES
TECHNIQUE
MAKE
LCMSMS (Triple Quad)
2 NOS

AB SCIEX API 3200

LCMSMS (Triple Quad)

Waters Quattra ...
ELEMENTAL IMPURITIES
•
•
•

Instrument : Perkin Elmer DV 7000 ICP oes
Detection Limit : ppb level detection
Matrix : Pharm...
1/13/2014

15
• FOOD & AGRICULTURE PRODUCTS TESTED











Bakery & Confectionary
Tea , Coffee & Cocoa
Preservatives & Addi...
CHEMICAL TESTING




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
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Pesticide Residue
Amino Acid
PAH
Dioxins
Aflatoxins
Mycotoxins
Moisture
Brix...
1/13/2014

18
• PATHOGEN TESTS
•
•
•
•
•
•
•

Ecoli
Salmonella
S.aureas
Total Plate Count
Shigella
Pseudomonas aeruginosa
Listeria

1/13...
• Assay by Microbiology
• Folic Acid
• Calcium Panthothenate
• Vitamin B12
Other Micro Biology Services :
1) BET Testing
2...
STUDIES OFFERED

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

A short turnaround time for testing
Good...
DOCTORS ANALYTICAL LABORATORIES PVT LTD

THANK YOU
1/13/2014

22
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Doctors Analytical Laboratories Pvt Ltd presentation pharma & food services

  1. 1. 1/13/2014 1
  2. 2. SERVICE AREAS • • • • • Pharmaceuticals Food and Agriculture Water Analysis Nutrients and dietary supplements Cosmetics 1/13/2014 2
  3. 3. TECHNIQUES OFFERED 1) 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) 1/13/2014 3
  4. 4. • Accreditations & Approvals NABL ACCREDITED (ISO 17025 : 2005) FDA (MAHARASHTRA) APPROVED US FDA REGISTERED (License Copy on Next Slide) 1/13/2014 4
  5. 5. 1/13/2014 5
  6. 6. 1/13/2014 6
  7. 7. 1/13/2014 7
  8. 8. 1/13/2014 8
  9. 9. 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 1/13/2014 9
  10. 10. • 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 1/13/2014 10
  11. 11. • 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 1/13/2014 11
  12. 12. • 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) 1/13/2014 12
  13. 13. • GENOTOXIC IMPURITIES TECHNIQUE MAKE LCMSMS (Triple Quad) 2 NOS AB SCIEX API 3200 LCMSMS (Triple Quad) Waters Quattra Micro GCMSMS Thermo Fisher ITQ 1100 GCMSMS (Triple Quad) Agilent 7000 • CAPABILITIES • Method Development & Validation • Methods developed • • • • • • Ethyl Methyl Sulphonate Sodium Azide N-Chloro Succinamide 3 – Fluro -2-Methylaniline Carbendazim Thiophenate Methyl 1/13/2014 Carbon Disulphide Dimethyl Sulphate Diethyl Sulphate 13
  14. 14. ELEMENTAL IMPURITIES • • • Instrument : Perkin Elmer DV 7000 ICP oes Detection Limit : ppb level detection Matrix : Pharmaceutical samples as per USP chapter 232 & 233 • ELEMENTAL IMPURITIES Lead Mercury Cadmium Zinc Aluminum Sodium Potassium Magnesium Manganese Copper Gold Silver Platinum Palladium Iridium Rhodium Ruthenium Osmium Molybdenu m Nickel Chromium Cobalt Barium Ruthenium Vanadium 1/13/2014 Arsenic Calcium Titanium 14
  15. 15. 1/13/2014 15
  16. 16. • FOOD & AGRICULTURE PRODUCTS TESTED           Bakery & Confectionary Tea , Coffee & Cocoa Preservatives & Additives Sugar & Confectionary Nutritional Supplements Infant Food Oils & Fats Animal Feeds Alcoholic Beverages Non – Alcoholic Beverages 1/13/2014 Edible Colours & Flavours Nuts Fruit & Fruit Products Cereals & Pulses Vegetable & Vegetable Products Honey & Honey Products Herbs, Spices & Condiments Oil & Oil Seeds 16
  17. 17. CHEMICAL TESTING               Pesticide Residue Amino Acid PAH Dioxins Aflatoxins Mycotoxins Moisture Brix Ash Protein Fat Carbohydrates Calories Dietary Fibre 1/13/2014 Preservatives Salts of Sorbic Acid Brix Total Soluble Solids Total Acidity Acid Insoluble Ash Fatty Acid Profile 17
  18. 18. 1/13/2014 18
  19. 19. • PATHOGEN TESTS • • • • • • • Ecoli Salmonella S.aureas Total Plate Count Shigella Pseudomonas aeruginosa Listeria 1/13/2014 19
  20. 20. • Assay by Microbiology • Folic Acid • Calcium Panthothenate • Vitamin B12 Other Micro Biology Services : 1) BET Testing 2) Efficacy Studies 1/13/2014 20
  21. 21. 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 1/13/2014 21
  22. 22. DOCTORS ANALYTICAL LABORATORIES PVT LTD THANK YOU 1/13/2014 22

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