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Revision of the general Chapter onPharmaceutical Water in the US Pharmacopoeia USP里制药用水通论修订 The 2nd supplement of USP39 NF34 comprisesthe revised version of the chapter on pharmaceutical water of the USPharmacopoeia <1231> Water for pharmaceutical purposes. The first draftversion had already been published in September 2015 in the USP Pharmacopeial Forum 41(5). USP38NF34的第2次增补包括了USP<1231>制药用水的修订。第一版草案已经于2015年9月在药典论坛41(5)公布。 First of all: there are no new or revised specificationsof individual test parameters or new requirements. But the chapter has beenrevised structurally to ensure better readability. In addition there are nowalso details regarding feed water as well as for the validation and onaction and warning limits. With a chapter number greater than 1000 the Chapter<1231> is not binding, but has a recommending character. The recommendedtemperature for hot sanitising was changed. So far temperatures of 80 ° C andgreater were recommended. Now these are 65-80 ° C. Regarding the action andwarning limits the USP now comprises proposals how these can be set 2 - and3-stepped and which rationale can be used for the limit-setting. Further, therevised chapter now also provides assistance for organising sampling plans forthe validation and operational phases. 总而言之：并没有对各检测参数指标有修订或增加新指标，也没有新的要求。但章节结构进行了调整，以确保更易读。此外，现在还详细说明了原水要求，以及验证和行动限及警戒限。作为编号大于1000的通论，<1231>并不是强制的，但是属于推荐的章节。其建立的热灭菌温度有改变。截止目前，建议的是大于等于80° C。现在改成了65-80 °C。关于行动限和警戒限，USP现在包括了建议如何在第2步和第3 步设定，可以使用什么原理来设定限度。更外，修订后的章节现在还提供了设计取样计划的帮助，用于验证和运行。 The revised version of the Chapter <1231> willbecome effective in December 2016 and can be found in the 2nd supplement to theUSP39 NF34. 修订后的<1231>将从2016年12月开始生效，可以在USP39NF34第2次增补中找到。
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