Pharmaceutical Water

Analytical testing is a critical part in every step of drug development and manufacturing. The qualitative and quantitative results generated from validated analytical testing provide first-hand information to control and ensure the quality and safety of raw materials, intermediates, and finished products. Like many other CMC (chemical, manufacturing and control) activities, analytical testing is also frequently outsourced. Many factors are attributed to this rapid market growth, including continuous outsourcing from pharmaceutical companies, growing pipelines for biological candidates, and increasing demand for more analytical details on drugs and process development by regulatory agencies. In response to the changing market dynamics, service providers are striving to provide analytical testing with quality, accuracy, and robustness all within tight timelines. As the contract research organizations (CROs) have become more integrated, small analytical labs need to establish their niche to succeed. Global contract analytical Laboratories provide QC laboratory analysis, method development, validation and expert advice for both finished products and raw materials for pharmaceutical and biopharmaceutical companies. Quality Compliance testing is done a wide variety of raw material and finished product forms including High Potent Active Pharmaceutical Ingredients (APIs), Raw Materials and Excipients, Powders - Capsules/Semi-solids, Oils - Oral Solutions and Syrups, Liquids, Vitamins, Minerals, and Nutritional, Natural Health Products (NHPs) – Powders, Herbals – Suspensions, Finished Pharmaceutical Products (Tablets, Capsules/Semi-solids, Oral Solutions and Syrups, Gels, Creams and Ointments, Powders, Suspensions, Transdermals etc. Microbial Testing covers Microbial limit tests, Total bacterial count, Yeast & mould, Escherichia coli, Salmonella, Shigella, Pseudomonas aeruginos, Staphylococcus aureus, Enterobacteria, Coliform, Sulphite reducing bacteria, Proteolytic/Lipolytic bacteria, Clostridium perfringens, Bacillus cereus, Vibrio cholerae , Vibrio parahaemolyticus, Faecal coliform, Faecal Streptococci, Sterility, Vitamin Assays, Antibiotic Assays, Water analysis, Antimicrobial Preservative Efficacy test etc. The water you use for manufacturing, cleaning, cooling, and filtration must be pure to ensure that your end product is not contaminated. Boston Analytical offers a complete line of USP purified water testing services with a rapid turnaround time to assist you with your critical water testing objectives. USP Purified Water Testing Services include Water Bioburden USP <1231> Testing, Total Organic Carbon (TOC) Testing USP <643> Sievers 900, Conductivity USP <645> Testing, Total Organic Compounds Testing, Bacterial Endotoxin Testing, Particulate Analysis <788> and <789> Testing, Purified Water System Validations, WIFI – water for injection, Sterile water for injection, RO/DI water systems etc.