EDQM publishes three revised Texts on Pharmaceutical Water

At its 182nd meeting in June 2025, the European Pharmacopoeia Commission (EPC) adopted three revised texts on pharmaceutical water: Water for Injections (0169); Purified water (0008); Total organic carbon content in water for pharmaceutical purposes (2.2.44). This is an important step towards further harmonisation of pharmacopoeia requirements between the Indian Pharmacopoeia, the Japanese Pharmacopoeia and the United States Pharmacopeia.

The revisions have already been published in Pharmeuropa 36.3 for consultation.
The most notable change concerns the monograph on water for injection in the section ‘Sterilised water for injection’, where the previous test for oxidisable substances has been replaced by the more sensitive and non-selective test for total organic carbon (TOC) in the section.

In general section 2.2.44, the reagents sucrose R and 1,4-benzoquinone R were replaced by chemical reference substances (CRS) to simplify the application of the TOC test.

The revised texts will be published in edition 12.3 of the European Pharmacopoeia (Ph. Eur.) in January 2026 and will enter into force on 1 July 2026.

The original announcement can be found on the EDQM website.