The information covered on the basis of real time experience with regulatory authorities. It also differs on case by case basis. Total impurity limits are generally based on total of all the impurities listed in profile. Thanks for comment.
The Mapp information is as below 2.1. The acceptance criterion for total impurities excluding significant human metabolites,8 generally, should not exceed the summation of acceptance criteria for individual specified (identified and unidentified) impurities. Acceptance criterion for individual impurities that are also significant human metabolites should be considered separately. The sum total of all impurity limits, including those for significant metabolites, should not exceed thresholds that may compromise product potency/assay through product expiry.
