美国药典重金属233.docVIP

USP 36-233 修订公告（中英文） 232 Elemental Impurities—Limits and 233 Elemental Impurities—Procedures 232元素杂质---限度和233元素杂质—检测方法 Type of Posting 公告类型 Revision Bulletin 修订公告 Posting Date 公布日期 28–Jan–2013 2013年1月28日 Official Date 正式发布时间 Feb–2013 2013年2月 Expert Committee 专家委员会 Executive Committee of the Council of Experts 专家组执行委员会 Pursuant to a Revision Bulletin posted on November 15, 2012 and updated on November 21, 2012, and in accordance with the Rules and Procedures of the 2010–2015 Council of Experts, the Executive Committee of the Council of Experts (CoE EC) postponed the official dates of 232 Elemental Impurities—Limits and 233 Elemental Impurities—Procedures. The purpose for the postponement was to allow adequate time for the CoE EC to adjudicate and render a decision on three appeals related to the two general chapters. Due to the similarity of issues raised, these appeals were consolidated and considered simultaneously as a single appeal. As noted in the prior Revision Bulletin, the portion of the appeal that was allowed to proceed and was considered by the CoE EC was that related to the content of the general chapters and their official dates. The portion of the appeal that related to the planned implementation of these chapters effective May 2014 through a proposed General Notices provision was denied as untimely, as the General Notices proposal at issue had not yet appeared in Pharmacopeial Forum (PF) for public notice and comment. 在2012年11月15日修订公告贴出，在2012年11月21日更新后，根据2010-2015专家委员会规则和程序，专家执行委员会推迟了232【元素杂质—限度】和233【元素杂质---方法】的公布时间。推迟的原因是使得专家委员会对两个通论章节相关的三个申请有充分的时间作出裁决和决定。由于提出的问题具有相似性，这些申请经过合并为单一申请。如之前修订公告中所示，委员会考虑的申请内容主要是关于通论章节的内容及其正式公布日期。申请的另一内容，与这些章节在2013年5月通过《通论》条款生效相关的内容，由于其提交过早被否决。事实上通论建议尚未在药典论坛上公开征求意见。 The CoE EC met on January 7, 2013 to consider the combined appeal on General Chapters 232 Elemental Impurities—Limits and 233 Elemental Impurities—Procedures. The Executive Committee was provided with the appeal documents in their entirety, inf