Pharmaceutical products and drug substances are analysed routinely as per the latest pharmacopeia (USP, BP, EP, IP. JP) or customer specified procedures and specifications.
Testing of raw material or compendial testing
[rt_list_style list_icon_test=”dfa78d3a-0a4e-10″]- Testing of raw material or compendial testing
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- Routine physicochemical analysis
- Assay
- Dissolution
- Characterization (Polarity, refractive index, density, viscosity and FTIR)
- Mineral trace and heavy metals by ICP-MS as per USP <232> and <233> / EP/ customer methods
- Organic volatile impurities and residual solvents
- Impurity profiling or genotoxic studies
- Impurity identification by LC-Q TOF-MS
- Amino acid analysis
- Vitamin assays
- Antibiotic Assays
- Microbiological tests [Microbial limit tests (MLT), Detection of specified pathogens, Preservatives efficacy test/ Antimicrobial efficacy test (PET/AET), Bacterial Endo-toxin Tests (BET)]
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- Pharmaceutical grade water testing as per USP/BP/EP/IP/WHO/customer requirement
- Cleaning validation
- Environment monitoring for bio-burden and identification of microorganisms as per USP <1116> (Molecular Biology methods)
- Stability studies
- Leachable and extractable
- Method development and validation
- Testing of disinfectant fluids as per Schedule O of The drugs and cosmetics rules 1945/ IS: 1061 or other international methods (EN/ASTM)
- Testing of cosmetics as per Schedule S of The drugs and cosmetics rules 1945/ USFDA methods
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