Analytical Chemistry studies
The studies are performed in full compliance with global guidelines, such as ASTM, ICH, OECD, OPPTS, SANCO, SANTE and so on. The laboratory is well equipped with the instruments for performing the studies accurately meeting the guideline requirement.
SANTE/2020/12830, Rev.2 and SANCO/3030/99 rev.5
This guideline provides a validation requirements and assessment for quantitative analytical methods and post-approval control and monitoring purposes. This can also be used for active substances. It also elaborate the parameters important for the validating a method and its acceptance criteria for different parameters. This framework includes a set of analytical steps to validate the method and response of test chemical on instrument.
