null Ph. Eur. to launch survey for the use of total organic carbon (TOC) test as a replacement of oxidisable substances test in Water for injections

EDQM Strasbourg, France 17/03/2022
Ph. Eur. to launch survey for the use of total organic carbon (TOC) test as a replacement of oxidisable substances test in Water for injections

The experts of the European Pharmacopoeia (Ph. Eur.) are considering replacing the test for oxidisable substances by the test for total organic carbon (TOC) in the Tests section of the “Sterilised water for injections” part of the monograph on Water for injections (0169). This change has been discussed with other pharmacopoeias (United States Pharmacopeia, Japanese Pharmacopoeia) and is already implemented in one of them. The experts of the Ph. Eur. would like to gather information from manufacturers, before the official consultation phase, to make sure that the method and acceptance criteria envisaged in the discussions with partner pharmacopoeias would be appropriate and feasible for European manufacturers of sterilised water in containers.

We would like to ask our industry stakeholders for support in gathering information on this subject, by responding to this survey. Supporting data can be sent to epd@edqm.eu.

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