What is the definition of an API mix? What information must be provided while submitting a DMF for API mix?

刊登日期:2020-07-23  |  點閱次數 : 872 次 
An API mix is defined as a mixture of an API and one or more excipient(s). One example is the addition of an antioxidant to an API.
If an API mix is listed in a compendial monograph, a DMF submission for the API mix would be accepted when information supporting the choice and the amount of the excipient(s) are provided. However, if no compendial monograph for the proposed API mix is available, a DMF for that the proposed API mix could only be accepted for stability or safety concerns. In cases like these, justifications including scientific evidences and supporting information for the choice and amount of the excipient(s) must be provided. When stability is concerned, for example,  at least 6-months of long-term stability data should be provided to demonstrate improvement in stability for the addition of the stabilizer(s) to an API.
If appropriate justifications have been provided and a DMF application for an API mix is accepted, section 3.2.S.2.2 in the DMF should contain all relevant information on the mixing process, qualitative and quantitative composition of the mixture, and control strategy for the mixing process and for the API mix.

上一筆 When submitting a DMF application, is it acceptable to submit only a batch manufa
下一筆 If a potential genotoxic impurity is formed or introduced prior to the final step