USP 36-233 修订公告 20130128 （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
2nb
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 2
1, 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---方张碧晨爱你的宿命
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, information outlining the prior consideration of appellants’ issues, and a comprehensive record of the standards-setting activities related to <232> and <233>. At its meeting, the Executive Committee reviewed the standards-setting record, the key points of each appeal, and how the Expert Panel and Expert Committee addressed each appellant concern. The Executive Committee determined that the information presented was sufficient for it to rule on the appeal.
幸福牵手
专家组执行委员会在飞鸟与蝉2013年1月7日开会，讨论合并公众对通论章节<232>【元素杂质—限度】和<233>【元素杂质---方法】的意见。执行委员会讨论了公众申请文件的完整信息，与<232><233>相关的标准设定活动综合记录。在此次会议中，执行委员会审核了标准起草记录，公众申请意见的关键内容，以及专家小组和专家委员会如何回复每个提交意见者的问题。执行委员会认为所呈交的信息足以保证对提交意见的管理。
The Executive Committee voted to uphold the general chapters, finding that 1) the Expert Committee and Expert Panel appropriately followed their processes and adequately considered appellants’ prior comments, and there was no new data or evidence presented that justifies further consideration by the Expert Committee or Expert Panel, and 2) an official date should be re-established for the chapters, ending their postponement. They further determined this official date to be February 1, 2013.
执行委员会投票赞成通论章节，包括（1）专家委员会和专家小组符合其程序，充分考虑了前期收到的公众意见，没有收到新数据或证据进行新的论证，（2）需要对这些章节提出一个正式发布日期，结束该延期。专家委员会进一步决定该正式发布日期为2013年2月1日。
As previously noted, USP intends to implement these general chapters through a proposed provision in the General Notices that would make <232> and <233> applicable to all articles in the compendia (except where noted otherwise) on May 1, 2014 (USP 37–NF 32). Conformance with <232> and <233> in applicable monographs will thus be required as of this date. This implementation approach for the general chapters also includes removal of all references to USP General Chapter <231> Heavy Metals from monographs in the USP–NF, also proposed in PF 39(1) for public comment. Note that <231> remains applicable until it is omitted.
之前已提过，USP小s经纪人会在2013年5月1日（USP 37-NF32）《通论》中发布一个条款将<232>和<233>应用于药典中所有条款（另有说明者除外），在此日期<232><233>也会被要求应用于各论中。这种通论实施方式也包括将USP-NF中各论里删除对<231>的引用，在PF39（1）中公布。注意<231>在其删除前仍有效。
This provision currently is proposed in Pharmacopoeial Forum (PF) 39(1) [Jan–Feb 2013] for public comment.  Stakeholders may submit comments on the General Notices propos
al until March 31, 2013 for consideration by the Executive Committee, which is responsible for revisions to General Notices.
本条款目前在PF39（1）【2013年1-2月】中提出公开征求意见。相关方可以在2013年3月31晶前提交对通论的意见，供负责通论修订的执行委员会考虑。
It is important to note that although General Chapters <232> and <233> will become official on February 1, 2013, there will be no requirement for an article covered by an applicable USP–NF monograph to comply with their provisions on this date. USP’s position is that until a general chapter is referenced in a monograph or in General Notices, it is not applicable to any article named in USP–NF. Typically, a standard becomes official six months after publication in a book or supplement, and implementation is required as of that official date. In this case, however, the official date is separate from the implementation date, as implementation cannot occur until the general chapters are referenced in a monograph or in General Notices.
王自健相声狂骂周立波