Biotech & Pharma
ANALYTICAL CHEMISTRY
⦁ PK analysis using LC-MS/MS
⦁ USP foreign matter test
⦁ USP <232> Elemental Impurities
⦁ Minerals by ICP-MS
⦁ Fat-soluble Vitamins: A, D, E, K1 and K2
⦁ Water soluble Vitamins: B1, B2, B3, B5, B6, B7, B9, B12, C and H
⦁ Amino Acids by HPLC (bound or free AA)
⦁ Protein concentration by HPLC
⦁ Peptides (Purity, strength, heavy metals, molecular weight, endotoxin, and micro)
⦁ Identity (chemical purity test)
⦁ Potency (concentration of active compounds)
⦁ Moisture
⦁ Water activity Karl Fisher
⦁ Specific gravity
⦁ Water TOC analysis
⦁ Residual solvents
⦁ Method development
⦁ pH
⦁ Water Conductivity
⦁ Custom assays
⦁ ICH stability storage
MICROBIOLOGY
⦁ Microbial bactericidal concentration studies
⦁ Microbial inhibitory concentration studies
⦁ USP <51> Antimicrobial Effectiveness Testing
⦁ USp <85> Endotoxin testing
USP <71> Sterility testing
⦁ USP <2021> Microbial Enumeration Tests – Nutritional and Dietary Supplements
⦁ USP <2022> Microbiological Procedures for Absence of Specified Microorganisms Nutritional and Dietary Supplements
⦁ USP <62> Microbiological Examination of Nonsterile Products: Suitability Test for Specified Microorganisms
⦁ USP <61> Microbial Examination of Nonsterile Products – Microbial Enumeration Tests
⦁ Disinfectant efficacy studies USP 1072, AOAC and EU
⦁ Custom antimicrobial efficacy studies for liquid and
surface coatings
⦁ Custom antimicrobial efficacy studies for UV sanitization devices
⦁ Environmental monitoring of clean rooms – viable and non-viable particle sampling, personnel gown sampling. Routine and clean room validation services.
Cell Culture
⦁ Development cell bank preparation
⦁ Cell culture MTT proliferation assays
⦁ Tissue culture media growth promotion assays
⦁ Cell-based bioassays