3.2.S.3.2 - Impurities
A detailed discussion regarding all potential impurities should be provided, incluing reagents, catalysts, by-products, solvents and degradation products. The discussion should comprise:
- Formation, fate and purge; and
- Control strategy and proposed acceptance criteria.
- The discussion should comprise specified and unspecified impurities, total impurities, elemental impurities, mutagenic impurities and justification for the absence of tests for potential impurities that are not controlled.
- Based on risk assessment, the validation of critical parameters of analytical procedures used in carry-over studies should be provided.