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2. SERVICE AREAS
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Pharmaceuticals
Food and Agriculture
Water Analysis
Nutrients and dietary supplements
Cosmetics
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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)
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4. • Accreditations & Approvals
NABL ACCREDITED (ISO 17025 : 2005)
FDA (MAHARASHTRA) APPROVED
US FDA REGISTERED
(License Copy on Next Slide)
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9. PHARMACEUTICAL SERVICES
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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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10. • Method Development & VALIDATION
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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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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
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12. • INVITRO DISSOLUTIONS / BIO WAIVER STUDIES
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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
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Method Validation For Kinetic Dissolution Test
Comparative Dissolution Profile With Innovator
Worked on dual detectors ie UV & Florescence
• Products
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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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13. • GENOTOXIC IMPURITIES
TECHNIQUE
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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
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Method Development & Validation
• Methods developed
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Ethyl Methyl Sulphonate
Sodium Azide
N-Chloro Succinamide
3 – Fluro -2-Methylaniline
Carbendazim
Thiophenate Methyl
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Carbon Disulphide
Dimethyl Sulphate
Diethyl Sulphate
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14. ELEMENTAL IMPURITIES
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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
Mercury
Cadmium
Zinc
Aluminum
Sodium
Potassium
Magnesium
Manganese
Copper
Gold
Silver
Platinum
Palladium
Iridium
Rhodium
Ruthenium
Osmium
Molybdenu
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Nickel
Chromium
Cobalt
Barium
Ruthenium
Vanadium
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Arsenic
Calcium
Titanium
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16. • FOOD & AGRICULTURE PRODUCTS TESTED
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Bakery & Confectionary
Tea , Coffee & Cocoa
Preservatives & Additives
Sugar & Confectionary
Nutritional Supplements
Infant Food
Oils & Fats
Animal Feeds
Alcoholic Beverages
Non – Alcoholic Beverages
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Edible Colours & Flavours
Nuts
Fruit & Fruit Products
Cereals & Pulses
Vegetable & Vegetable Products
Honey & Honey Products
Herbs, Spices & Condiments
Oil & Oil Seeds
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17. CHEMICAL TESTING
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Pesticide Residue
Amino Acid
PAH
Dioxins
Aflatoxins
Mycotoxins
Moisture
Brix
Ash
Protein
Fat
Carbohydrates
Calories
Dietary Fibre
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Preservatives
Salts of Sorbic Acid
Brix
Total Soluble Solids
Total Acidity
Acid Insoluble Ash
Fatty Acid Profile
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19. • PATHOGEN TESTS
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Ecoli
Salmonella
S.aureas
Total Plate Count
Shigella
Pseudomonas aeruginosa
Listeria
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20. • Assay by Microbiology
• Folic Acid
• Calcium Panthothenate
• Vitamin B12
Other Micro Biology Services :
1) BET Testing
2) Efficacy Studies
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21. STUDIES OFFERED
• Customer service is our passion - put us
to the test!
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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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22. DOCTORS ANALYTICAL LABORATORIES PVT LTD
THANK YOU
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