Biotech & Pharma

ANALYTICAL CHEMISTRY

⦁ Foreign matter
⦁ Macroscopic and microscopic examination
⦁ Heavy metals (USP <232> Elemental Impurities
⦁ Minerals by ICP-MS
⦁ Essential oils
⦁ Fat soluble Vitamins: A, D (Calciferol), E (Alpha-Tocopherol), K1 (Phytomenadione) and K2 (Menaquinones)
⦁ Water soluble Vitamins: B6 (Pyridoxine), B12, C (Ascorbic Acid), Biotin, B3 (Niacin), B9 (Folic Acid), B5 (Pantothenic acid), Thiamin (B1), B2 (Riboflavin), B12
(Cobalamin), H (Biotin),
⦁ Amino Acids
⦁ Protein content by HPLC
⦁ Physical characteristics (visual, color, odor, taste, density, mesh size)
⦁ Identity (chemical purity test)
⦁ Potency (concentration of active compounds)
⦁ Moisture
⦁ Water activity

Water content by Karl Fisher
⦁ Specific gravity
⦁ Pesticides
⦁ Residual solvents
⦁ Mycotoxins
⦁ Method development
⦁ pH
⦁ Conductivity

Total Organic Carbon (TOC)

FTIR material identification

MICROBIOLOGY

⦁ Anaerobic plate count
⦁ Available water (water activity)
⦁ Bacillus cereus count
⦁ Clostridium perfringens
⦁ Coliform count (VRBA)
⦁ E. coli (3M Petrifilm)
⦁ Enterobacteriaceae
⦁ Enterobacteriaceae (3M Petrifilm)
⦁ Enterococci / fecal streptococci count
⦁ Lactobacilli count
⦁ Listeria monocytogenes
⦁ Microbial bactericidal concentration studies
⦁ Microbial inhibitory concentration studies
⦁ Salmonella
⦁ Staphylococcus aureus count
⦁ Thermophilic aerobic plate count
⦁ Yeast and mold count
⦁ 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
⦁ Custom antimicrobial efficacy studies for liquid and
surface coatings
⦁ Custom antimicrobial efficacy studies for
UV sanitization devices
⦁ Microbial custom studies

USP <85> Bacterial endotoxin test

Container closure integrity testing – dye leak test and microbial immersion test