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Purified Water Monography: New Draft in European Pharmacopoeia 9.4

A draft of the monography to Purified Water was published in the European Pharmacopoeia, which includes a new section on Elemental Impurities:


Elemental impurities: If purified water in bulk does not meet the requirement for conductivity prescribed for Water for injections (0169) in bulk, a risk assessment according to general chapter 5.20 Elemental impurities is carried out. The risk assessment should consider the role of water in the manufacturing process, in particular when water is used in a process but is no longer present in the final product.

Another change that will enter into force on 1 April 2018, is that the appearance and the nitrate level of purified water do not have to be tested anymore. The USP and the Japanese Pharmacopoeia, as well, do not include these requirements. The testing for appearance and nitrate level are still requested by the Indian and Chinese Pharmacopoeia.

If you are interested in more information, please take a look at the logfile written by our author Fritz Röder, who summarized the above information.

Hello, I did not found that the appearance and nitrate level will not be tested anymore in the new monograph. Can you explain?
ana fritschy 2017-11-21
Indeed, the planned changes in the monograph are not so obvious. Per e-mail we will send you a screenshot of the online version. The deleted paragraphs are marked with scissors. Appearance and the test for nitrates will no longer appear in the PW monograph.
Editorial Office GMP-Publishing 2017-11-21
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The New USP <1231>: Water for Pharmaceutical Purposes
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