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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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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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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