FAQ
Drugs

Where should the relevant information on leachables and extractables of container closure system be included in?

刊登日期:2019-11-13  |  點閱次數 : 1493 次 

The relevant information on leachables and extractables of container closure system should be included in 3.2.P.2.4. If necessary, information on leachables should also be included in 3.2.P.5.1 and 3.2.P.5.5. In addition, if leachables are confirmed through shelf-life as part of the formal stability studies, the relevant results should be presented in 3.2.P.8.3.

 

(中文版)


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