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修訂后的USP<670>容器 - 包裝附件

Revised USP Chapter <670> Containers - Auxiliary Packaging Components
修訂后的USP<670>容器 - 包裝附件

A revised version of USP general chapter <670> Auxiliary Packaging Components was published for comments in Pharmacopoeial Forum 42(1), January-February 2016.
修訂后的USP通論<670>包裝附件已公布在藥典該款42(1)期,在2016年1-2月征求意見。

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.
之前修訂的<670>于2014年11-12月公布在藥典論壇40(6)中,將在2016年5月1日正式發(fā)布(USP39-NF34)。該修訂包括了引入包裝干燥劑藥典標(biāo)準(zhǔn)。常用商業(yè)干燥劑為膨潤(rùn)土、氯化鈣、氧化鈣、分子篩和硅膠。在通論中描述了對(duì)這些物料的特定測(cè)試和檢查。

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.
其它干燥劑要進(jìn)行適當(dāng)?shù)臏y(cè)試,以確保其適合既定用途。干燥劑可以是直接與包裝容器的壁或蓋相結(jié)合,也可以是由載體物料阻隔。

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.
在藥典該款42(1)期收到的建議的基礎(chǔ)上,提出建議在其中對(duì)通論<197>分光光度法鑒別測(cè)試進(jìn)行交叉索引,以提高<670>中對(duì)藥用線圈段落中紅外光譜部分所需要的靈活性。這樣,ATR技術(shù)可以用作替代方法。

Deadline for comments is March 31, 2016.
征求意見截止日期為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網(wǎng)站注冊(cè)后,你就可以獲得完整的修訂后草稿。

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