USP updates its water monographs: recombinant reagents permitted for endotoxin testing
USP has updated its monographs on the various types of water for pharmaceutical purposes. The main change: recombinant reagents (<86>) may be used for bacterial endotoxins testing as an alternative to the traditional LAL reagent (<85>).
USP has updated its monographs on the various types of water for pharmaceutical purposes — Purified Water, Water for Injection, Bacteriostatic Water for Injection, Sterile Water for Inhalation, Sterile Water for Injection, Sterile Water for Irrigation and Pure Steam. The revised monographs become official on 1 April 2026. The main change is that recombinant reagents (<86>) may be used for bacterial endotoxins testing as an alternative to the traditional LAL reagent (<85>); the endotoxin limits remain unchanged. Changes to the main general chapter <1231> Water for Pharmaceutical Purposes are mostly editorial; the chapter also incorporates material from the frequently asked questions section of the official USP website (sampling, handling of additives, risks such as nitrosamines).
This review was prepared for the News section of the journal «Oʻzbekiston farmatsevtik xabarnomasi» (Pharmaceutical Bulletin of Uzbekistan).
Source: www.usp.org