关于可萃出物和浸出物的新USP通则<1663>、<1664>

20151104 ECA新闻：关于可萃出物和浸出物的新USP通则<1663>、<1664>  

GMP News
04/11/2015

New USP General Chapters on Extractablesand Leachables: <1663>, <1664>

关于可萃出物和浸出物的新USP通则<1663>、<1664>

Two new USP General Chapters onextractables and leachables which had been proposed in Pharmacopeial Form39 (5) have become official on August 1, 2015 (USP 38-NF33, first supplement):

在药典论坛39（5）中拟定两个关于可萃出物和浸出物的新通则自2015年8月1日正式公布（USP38-NF33，第一增补）：

·        <1663>  Assessment of Extractables Associatedwith Pharmaceutical Packaging/Delivery Systems and

·        <1663>药用包装/给药系统中的可萃出物评估

·        <1664> Assessment of Drug Product LeachablesAssociated with Pharmaceutical Packaging/Delivery systems.

·        <1664>药用包装/给药系统中药品可浸出物评估

These chapters are intended to beinformational. They provide a framework for the design, justification, andexecution of extractables/leachables assessments for pharmaceutical packagingsystems. They do not present specific experimental conditions, specific tests,analytical procedures or acceptance limits for packaging systems or products.

这两章目的是提供相关信息。他们提供了设计、论证和实施药品包装系统中可萃出物/浸出物评估的框架。他们并没有给出包装系统或药品的详细实验条件、特定测试、分析方法或可接受限度。

Additionally, the PSD Expert Committeeplans a general chapter <1665> on the Toxicological SafetyAssessment of Extractables and Leachables (announced in PF and39(6)). The chapter is expected to provide a framework for performinga toxicological safety assessment. It is not expected to providespecific protocols or specifications.

另外，PSD专家组正在策划一个通则<1665>，是关于可萃出物和浸出物的毒性安全评估（在PF39（6）中公布）。该章节将提供实施毒性安全评估的框架，但并不提供详细的实施方案或质量标准。

However, the above mentioned GeneralChapters might get a more official character when implemented in USPMonographs or General Chapters on dosage forms products-quality tests. In therecent issue of PF 41(5) reference to the two new Chapters <1663> and <1664> has been integrated in the Drafts of General Chapters onOphthalmic Products <771> and Injections <1>. Therefore, infuture, it might be necessary to discuss the scientific principles andbest demonstrated practices for extractables/leachables studies. In addition,the assessment of possible leachables/extractables and the establishment ofacceptance criteria for these substances might be based on riskassessments for a specific combination of product, indication, route ofadministration, and packaging system. The comment deadline for the in PF41(5) proposed chapters is November 30, 2015.

在实施与制剂剂型相关的质量测试的USP各论或通论时，上述通则可能会有更多正式章节。在最近PF41（5）中，这两个新章节<1663>和<1664>已经被整合进了眼剂<771>和注射剂<1>的通则草案中。国在线，在将来，可能会需要讨论可萃出物/浸出物研究的科学原理和经过证明的规范，并根据特定的产品、指票、给药途径和包装系统组合的风险评估来为这些物质建立可接受标准。在PF41(5)中所拟章节的征求意见截止时间为2015年11月30日。

Following your registration on the USP Pharmacopeial Forum  website youcan get to the complete drafts of the USP General Chapters.

免费注册后，你可以登录USP药典论坛获得完整的USP通则草案。

Looking for more Information? Bepart of next year's course on Leachables & Extractables -Testing & Assessment - from 26-27 April 2016 in Copenhagen!

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