FAQ
Drugs

Should the information of reference standards for all impurities listed in the specification of drug substance be provided in section 3.2.S.5 Reference Standards or Materials?

刊登日期:2020-07-22  |  點閱次數 : 700 次 

Not necessarily, only information of reference standards which are used in the analytical procedures included in the specification of drug substance must be listed in the section 3.2.S.5 Reference Standards or Materials. For example, the drug substance specification includes four related substances, Impurity A, Impurity B, Impurity C, and Impurity D but only the reference standards for Impurity D and drug substance are required in the related substances method. Therefore, the information for reference standards of Impurity D and drug substance must be provided.

 

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