USP proposed to Revise the General Chapter <1092> on Dissolution

31/01/2014 00:41


The USP General Chapters - Dosage Forms Expert Committee has proposed to revise General Chapter <1092> The Dissolution Procedure: Development and Validation. The proposed revision will include additional information on: 
1) Preliminary assessments needed before initiating procedure development,  
2) Automation, and 3) Acceptance criteria and interpretation of results from a dissolution test..A companion Stimuli article explains the rationale and content of this proposed revision. General Chapter <1092> and the associated Stimuli article have been published in Pharmacopeial Forum 40(1).  Source: USP Notices.