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出自识林

2013-11-23 USP-NF

总则<1092>溶出度程序：开发和验证 总则 — 剂型专家委员会建议修订总则<1092>溶出度程序：开发和验证。除了重新组合现有内容外，建议修订以下附加信息：启动程序开发前需要初步评估；自动化；验收标准和溶出度检测的结果解释。

General Chapter <1092> The Dissolution Procedure: Development and Validation
Type of Posting　　General Announcement
Posting Date　　　　22–Nov–2013
Expert Committee　General Chapters—Dosage Forms

The General Chapters—Dosage Forms Expert Committee is proposing to revise General Chapter <1092> The Dissolution Procedure: Development and Validation. In addition to a reorganization of the existing content, the proposed revision will include additional information on:

• Preliminary assessments needed before initiating procedure development,
  
• Automation, and
  
• 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 approved for publication in Pharmacopeial Forum 40(1) [Jan.-Feb. 2014]. Both are being presented in advance of publication of PF 40(1) to allow additional time for public review and comment. Comments will be accepted until March 31, 2014, the end of the comment period for Pharmacopeial Forum 40(1).

• <1092> The Dissolution Procedure: Development and Validation
• Stimuli article: Revision of <1092> The Dissolution Procedure: Development and Validation

Should you have any questions or comments, please contact Will Brown, Senior Scientific Liaison, at (301-816-8380 or web@usp.org).

原文请见 General Chapter <1092> The Dissolution Procedure: Development and Validation