Back EPC adopts three revised texts related to pharmaceutical waters – a major step towards global quality standards for sterilised water for injections

EDQM Strasbourg, France 18/07/2025
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EPC adopts three revised texts related to pharmaceutical waters – a major step towards global quality standards for sterilised water for injections

The European Pharmacopoeia Commission (EPC) adopted three revised texts related to pharmaceutical waters during its 182nd session in June 2025. This constitutes a significant step forward in converging quality standards for the most widely used excipients in the pharmaceutical industry. The revised texts are:

  • Water for Injections (0169);
  • Water, purified (0008);
  • Total organic carbon in water for pharmaceutical use (2.2.44).

These revisions, initially published for public consultation in Pharmeuropa 36.3, reflect the EPC’s commitment to modernising analytical methods. The most notable change is in the monograph on Water for injections, where the conventional test for oxidisable substances was replaced with the more sensitive and non-selective total organic carbon (TOC) test in the section on “Sterilised water for injections”. This shift enhances the detection of organic impurities and supports a more robust quality control framework.

In general chapter 2.2.44, the reagents sucrose R and 1,4-benzoquinone R were replaced with chemical reference substances (CRSs) to streamline the application of the TOC test.

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

As part of its work in the Pharmacopoeial Discussion Group and in close collaboration with the Indian Pharmacopoeia Commission, the Japanese Pharmacopoeia and the United States Pharmacopeia, the Ph. Eur. is fully committed to progressing with the harmonisation of the monographs on Water for Injections (0169) and Water, purified (0008).