Ph. Eur.: Revised Monographs on Pharmaceutical Water
At its June 2025 session, the European Pharmacopoeia Commission (EPC) adopted three revised texts on pharmaceutical waters. This is an important step towards achieving international harmonisation with the pharmacopoeias of India, Japan and the US.
The monographs affected are:
- Water for Injections (0169)
- Purified Water (0008)
- Total Organic Carbon (TOC) in Water (2.2.44)
According to the EDQM, the most notable change is the replacement of the traditional oxidisable substances test with the more sensitive and non-selective TOC test in the “water for injections” monograph. The updated texts will be published in Ph. Eur. 12.3 (Jan 2026) and become effective on 1 July 2026.
Source:
EDQM: Newsroom
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