Quality Control

Physico-Chemical testing

• General identification (TLC, HPLC)
• Assay (UV/VIS, HPLC-UV, GC-FID, LC-MS/MS) and dosage uniformity
• Related substances identification and quantification (HPLC-UV, GC-FID, LC-MS/MS)
• Physical determinations (pH, viscosity, density)
• Moisture (Karl Fisher, Loss on Dry)
• Solid oral dosage tests (Disintegration, Dissolution, Hardness and Friability)
• Residual solvents (volatile organic compounds and impurities)
• Process environmental analysis (cross-contamination, rinse water, swabbing surfaces)
• Genotoxic and Nitrosamines testing
• Nitrites testing

Microbiological testing

• Microbial counting
• Determination of pathogens
• Water analysis
• Environmental monitoring (Active/Passive/Contact)