Is splitting of tablets testing considered an essential part of release and shelf-life specification for scored tablets with one or more breaklines?

刊登日期:2019-11-22  |  點閱次數 : 1656 次 

Yes. In general, the uniformity of the splitting tablets should be examined at the development stage. Please see Chinese Pharmacopoeia Edition 8 (1022) for the details of the requirements (or USP <705> quality attributes of tablets labeled as having a functional score).



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