If a new drug substance is not yet listed in any pharmacopoeial monograph, how does one establish the acceptance criterion for total (organic) impurities in the drug substance specification?

刊登日期:2020-07-22  |  點閱次數 : 1066 次 

The setting of the acceptance criterion for total (organic) impurities in a new drug substance specification should be based on the impurity test data from both relevant historical batches and production batches. Among these historical data, all impurities at a level greater than the reporting threshold should be summed and reported as total impurities. These impurities can be further divided into three different types of impurities: specified identified impurities, specified unidentified impurities, and any unspecified impurity. The data for each type of impurity should be evaluated to meet the ICH Q3A criteria for identification and qualification. If the observed maximum of any impurity is higher than the identification threshold, the structure of the impurity should be identified. If the impurity level is higher than the qualification threshold, safety data should be provided. The above-mentioned structure identification data and safety data should be provided in order to support the rationale for establishing the acceptance criteria for total impurities. (Referenced to ICH Q3A, ICH Q6A and ICH Q6A decision tree #1)



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