修订后的USP<670>容器----包装附件

julia朱玉姣

GMP News
07/01/2016

Revised USP Chapter <670> Containers - Auxiliary Packaging Components

修订后的USP<670>容器----包装附件

A revised version of USP general chapter <670> Auxiliary Packaging Components was published for comments in Pharmacopoeial Forum 42(1), January-February 2016.  

修订后的USP通论<670>包装附件已公布在药典该款42（1）期，在2016年1-2月征求意见。

The previously revised chapter <670> was published in Pharmacopoeial Forum 40(6), November-December 2014, and will become official on May 1, 2016 (USP 39-NF 34). This revision included the introduction of compendial standards for packaging desiccants. Common types of commercial desiccants are, for example, bentonite, calcium chloride, calcium oxide, molecular sieves, and silica gel. For these materials specific tests and assays are described in the general chapter.

之前修订的<670>于2014年11-12月公布在药典论坛40（6）中，将在2016年5月1日正式发布（USP39-NF34）。该修订包括了引入包装干燥剂药典标准。常用商业干燥剂为膨润土、氯化钙、氧化钙、分子筛和硅胶。在通论中描述了对这些物料的特定测试和检查。

Other desiccants are subject to appropriate testing to ensure suitability for the intended application. The desiccants may be incorporated directly into the wall or cap of packaging containers or bound by a carrier material.

其它干燥剂要进行适当的测试，以确保其适合既定用途。干燥剂可以是直接与包装容器的壁或盖相结合，也可以是由载体物料阻隔。

On the basis of a comment received, in Pharmacopoeial Forum 42(1) it is proposed to cross reference general chapter Spectrophotometric Identification Tests <197>, to add the needed flexibility to the Infrared Spectroscopy section of paragraph Pharmaceutical Coil in chapter <670>. Therefore, the ATR technique can be used as alternative method.

在药典该款42（1）期收到的建议的基础上，提出建议在其中对通论<197>分光光度法鉴别测试进行交叉索引，以提高<670>中对药用线圈段落中红外光谱部分所需要的灵活性。这样，ATR技术可以用作替代方法。

Deadline for comments is March 31, 2016.

征求意见截止日期为2016年3月31日。

After registration on the USP website you will have access to the complete draft of the revised chapter.

在USP网站注册后，你就可以获得完整的修订后草稿。

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