What document should be submitted for system suitability of the dissolution assembly in the dissolution profile comparison report?

刊登日期:2019-10-25  |  點閱次數 : 1086 次 

To ensure the integrity of the dissolution procedure is achieved, system suitability of dissolution assembly should be checked and documented before performing the dissolution profile comparison study. Document for the system suitability can be provided as: (1) The result of analytical instrumental qualification (3Q), including performance verification test using USP Prednisone Reference Standard Tablets, or (2) Enhanced Mechanical Calibration report (Reference : Guidance for Industry:The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2 – Current Good Manufacturing Practice(CGMP), published by USFDA in January 2010)




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