Pharmaceutical Analytical Method Development
Reliable and reproducible analytical methods are essential to both the pharmaceutical development process and the evaluation of drug product to meet the standard of potency, purity and stability. Analytical chemists will work to develop, qualify and validate methods or refine existing analytical methods to meet these demands. We also have a DEA analytical permit for CII-CIV products.
- Method development, validation and routine testing.
- Identity, quantitation, potency, content uniformity.
- Process contaminants, impurities, degradants, excipients.
- Lot release and stability assessment.