美国药典关于制药用水的问答

USP Q&A Paper on Pharmaceutical Water美国药典关于制药用水的问答

The website of the US Pharmacopoeia (USP) comprises a document with frequently asked questions and answers on the subject of pharmaceutical water. The not very well known page contains some very interesting points.

美国药典（USP）官网上包括一份关于制药用水的常见问题文件。这个不太为人所知的网页上包括了一些非常有意思的东西。

In total, there are 21 frequently asked questions on the topics of water for pharmaceutical or analytical use. Many questions deal with the off-line testing of parameters such as microbiology or TOC, and how samples need to be handled. In many places further explanations are given on the chapters <643> (TOC) and <645> (conductivity), which are missing in the actual monographs. It is also explained why the US Pharmacopoeia no longer defines requirements for the test criteria nitrate or pH. These were deleted several years ago and are covered by compliance with the conductivity test point. In another interesting point, the weak points or critical points in a WFI system are explained. For example, for sub-loops of hot systems that are used cold, the hot phase during sanitization should be sufficiently long. Especially the water enclosed in heat exchangers requires sufficient time to become sufficiently hot. The same applies to water in dead legs. The problem of an increased endotoxin content after or despite the distillation is also addressed. This can happen with poorly maintained components of the upstream purification steps, as well as with strongly fluctuating raw water quality.

这里总共有21个关于制药用水或分析用水方面的主题的常见问题。许多问题是关于离线参数检测的问题，例如，微生物或TOC，以及如何处理样品。在许多地方对<643>（TOC）和<645>（电导率）给出了进一步解释，这些内容在各论里并没有。这也解释了为什么美国药典不再定义亚硝酸盐或pH检测的要求。这些内容在数年前被删除了，包括在了电导率测试点符合性中。在另一个有意思的地方，解释了一个WFI系统中的薄弱点和关键点。例如，热水系统的循环支线使用冷水，灭菌过程中的高温阶段应足够长。尤其是热交换器中存留的水需要有足够的时间变得够热。这同样适用于死管中的水。问答里还说明了蒸馏后内毒素增加的问题。如果上游净化步骤的部件维护不善，或者是原水质量波动剧烈，就可能会发生该问题。

On the USP website you can find the Q&A Document on the subject pharmaceutical water.

在USP的官网上，你可以找到问答全文。