Analytical Method Development (AMD) and Analytical Method Validation (AMV)
OTH is proficient in carrying out essential and complex method development and method validation studies for drugs, excipients, impurities, residual solvents, powdered samples, dissolution samples, microbiological tests, bacterial endotoxins, trace metals, heavy metals and catalyst residues. The method development and validation studies are performed in accordance with ICH guidelines and systematic procedures by the experienced scientists of OTH.
The parameters evaluated for the method development and validation include:
The procedure followed for Analytical Method Validation :
Stability Chambers for stability conditions continuously monitored by Automated Monitoring System with full back up power and water supplies.
Dissolution Profiling Studies
OTH is adept in conducting significant dissolution profiling studies for the generic pharmaceutical industry. The studies effectively help the clients with identification of formulation factors that influence bioavailability of the API and gauge quality assurance and bioequivalence.
Preservative Efficacy Testing
OTH has proven expertise and capabilities in performing Preservative Efficacy Tests (also known as Antimicrobial Efficacy Tests) for the assessment of antimicrobial preservation of pharmaceutical, cosmetic and personal care products.