The European Pharmacopoeia Commission (EPC) has adopted three revised texts on pharmaceutical waters, marking a major advancement in harmonising global quality standards — especially for sterilised Water for Injections.
🔍 Key Updates:
-
Water for Injections (0169): TOC test replaces oxidisable substances test, enabling better detection of organic impurities.
-
Purified Water (0008): Revised as part of harmonisation efforts.
-
TOC Test (2.2.44): Reagents replaced with Chemical Reference Substances for streamlined testing.
🧫 These changes reflect a shift toward modern analytical methods and reinforce the robustness of pharmaceutical water quality control. The revisions were adopted in June 2025 and will be published in Ph. Eur. Issue 12.3 (Jan 2026), becoming effective on 1 July 2026.
🤝 The updates are aligned with harmonisation efforts involving India, Japan, and the US through the Pharmacopoeial Discussion Group.
👉 Click here to read the full details and regulatory context
