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