请问大家USP(R31）是那份文件呢？？

beiwei5du

各位老师大家好！我在《药品GMP指南》（厂房和设备）下看到下图这句话，想咨询USP(R31)是什么呢？？我看到USP(31)中是volumetric apparatus（量器），感觉不对头啊！是以前版本的USP内容么？？求指导！

leehwadong

美国药典一般简称USP。R31应该是第31卷或第31版吧。

罗伊鲱

Water—As elsewhere in the Pharmacopeia, where “water,” without qualification, is mentioned in the tests for reagents or in directions for preparing test solutions, etc., Purified Water (USP monograph) is always to be used. Carbon dioxide-free water is Purified Water that has been boiled vigorously for 5 minutes or more and allowed to cool while protected from absorption of carbon dioxide from the atmosphere, or Purified Water that has a resistivity of not less than 18 Mohm-cm. Deaerated water, for purposes other than dissolution and drug release testing, is Purified Water that has been treated to reduce the content of dissolved air by suitable means, such as by boiling vigorously for 5 minutes and cooling or by the application of ultrasonic vibration. Particle-free water is water that has been passed through a 0.22-µm filter.

Organic-free water is Purified Water that produces no significantly interfering peaks when chromatographed as it is
indicated in Identification, Control, and Quantification of Residual Solvents under Residual Solvents 〈467〉.

Water, Ammonia-Free, H2O—18.02—Use High-Purity Water as defined for Chemical Resistance under Containers— Glass 〈660〉.
Water, Carbon Dioxide-Free—See Water, in the introductory section.
Water, Deaerated—See Water, in the introductory section.

beiwei5du

roadman 发表于 2015-1-27 11:01
Reagent 31

还是没怎么搞懂呢！能不能具体说一下！麻烦指导了！谢谢你！