7. QUALIFICATION OF IMPURITIES

Qualification is the process of acquiring and evaluating data that establishes the biological safety of an individual impurity or a given impurity profile at the level ( s ) specified .The level of any impurity present in a new drug substance that has been adequately tested in safety and/or clinical studies would be considered qualified .Safety assessment studies to qualify an impurity should compare the new drug substance containing a representative amount of the new impurity with previously qualified material .