8/9 June 2021
The 2nd supplement of USP39 NF34 comprises the revised version of the chapter on pharmaceutical water of the US Pharmacopoeia <1231> Water for pharmaceutical purposes. The first draft version had already been published in September 2015 in the USP Pharmacopeial Forum 41(5).
First of all: there are no new or revised specifications of individual test parameters or new requirements. But the chapter has been revised structurally to ensure better readability. In addition there are now also details regarding feed water as well as for the validation and on action and warning limits. With a chapter number greater than 1000 the Chapter <1231> is not binding, but has a recommending character. The recommended temperature for hot sanitising was changed. So far temperatures of 80 ° C and greater were recommended. Now these are 65-80 ° C. Regarding the action and warning limits the USP now comprises proposals how these can be set 2 - and 3-stepped and which rationale can be used for the limit-setting. Further, the revised chapter now also provides assistance for organising sampling plans for the validation and operational phases.
The revised version of the Chapter <1231> will become effective in December 2016 and can be found in the 2nd supplement to the USP39 NF34.