ANALYTICAL QUALITY SERVICES
The generic product development ranges in complexity from oral solids to injectables with a focus on products that have a high entry barrier. Drug product development emphasizes continuous quality at each step.
cGMP/GLP Services include the Raw Materials testing, Packaging materials testing, Drug Product exhibit, and commercial batches testing, Stability Storage as per ICH conditions and Testing, Analytical Method Development, Validation, Verification, Transfer. Naso-Gastric Tube testing Comparative Dissolution Testing for a wide range of product dosages forms. All the testing instruments comply with 21 CFR Part 11. USFDA audited with Zero 483.
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Analytical Instrumentation: All the instruments complies with 21 CFR part 11
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- Stability Chambers
(Accelerated/Intermediate/Long term Stability conditions)
- Stand-by Stability chamber
- Humidity Chamber
- Cooling Chamber
- Photo stability chamber
- Deep Freezer
- Friability tester
- Tablet Hardness Tester
- Vibro sifter
- Powder Density tester
- Dissolution apparatus
- Shimadzu and waters HPLC (UV & RI & PDA Detector)
- Gas chromatograph with head space
- UV-Visible spectrophotometer
- FT-IR Visible spectrophotometer
- Auto KF Titrator
- Water purification system
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Analytical Accessories:
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- Balance (Analytical, Precision & Micro)
- pH meter
- Vacuum oven
- Hot air oven
- Water bath
- UV Cabinet
- Vortex mixer
- Ultrasonic bath
- Fume Hood
- Magnetic Stirrer with Hot plate
- Centrifuge
- Muffle furnace
- Vacuum Desiccator
- Orbital shaker incubator
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