Method Development and Validation per USP <1225> and ICH
Method Development and Validation services are offered for residual solvents testing for individual APIs and drug products, API and preservative assays in drug products, and impurities in APIs and drug products. These services are also offered for materials and testing requirements that are not covered by compendia specifications.
Validation of methods developed by Advanced Analytical Testing Laboratories is performed according to the requirements in USP general chapter <1225>. Validation studies include determination of the linearity, range, accuracy, repeatability, and intermediate precision of the method. For residual solvents and impurities methods, validation also includes determination of the limit of detection and the limit of quantitation.