EP Commission (EPC) - adopts three revised texts related to pharmaceutical waters
- Date
- July 21, 2025
- Category
EU Regulations
- Description
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 excipient 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 modernizing analytical methods. The most notable change is in the monograph on Water for injections, where the conventional test for oxidizable substances was replaced with the more sensitive and non-selective total organic carbon (TOC) test in the section on “Sterilized water for injections”. This shift enhances the detection of organic impurities and supports a more robust quality control framework.
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.