20150319 ECA新闻：USP通论<1010>修订

20150319 ECA新闻：USP通论<1010>修订  

2015-03-27 00:00:54|  分类： ECA新闻

来源：http://zhuyujiao1972.blog.163.com/blog/static/9869472720152270054668/

GMP News
11/03/2015

Revision of the General USP Chapter <1010

USP通论<1010>修订

In the Pharmacopoeial Forum 40(3) the In-process-revision of the general USP Chapter <1010> - Analytical Data - Interpretation and Treatment - was announced. This revision was suggested due to the proposals the USP received for this capter.
在药典论坛40（3）里，公布了正在修订中的通论USP<1010>分析数据---诠释和处理。该修订是因为收到了关于此章建议。

The part on the use of USP reference substances now also describes more detailed the handling of secondary standards which can be traced back to the USP reference standards.

USP对照品的使用部分现在也描述了更多处理工作标准品的细节，该工作标准品可以追溯至USP对照品。

Further, in the entire document the term "method" was replaced by the term "procedure" as far as the description of analytical testing is concerned. This was done in adapting the document to today's USP terminology.

并且，在整个文件中，关于检验方法的描述中，所有术语“方法”一词全部被术语“程序”替代。这是为了采用现今的USP术语。

In addition there will be a new Appendix F in which a new statistical test is described for the evaluation of the equivalence of analytical procedures.
另外，还会有一个新的附录F，在其中描述了一个新的统计测试用于评估分析方法的等同性。
Please see the chapter <1010> - Analytical Data - Interpretation and Treatment for further information.

关于<1010>分析数据---诠释和处理更多信息参见USP药典论坛。

Source: USP - http://www.usp.org