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 : 1507 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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Drugs Medical Devices Consultation Services Health Technology Assessment International Cooperation

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

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