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INTRODUCTION TO USP <922>: General Chapter for Water ...

ARTICLE. INTRODUCTION TO USP <922>: General Chapter for Water Activity Measurement . By Michael Lally, Application and Validation Specialist at Lighthouse Instruments The newly drafted USP <922> General Chapter describes the specific methods that pharmaceutical companies will use to calibrate, qualify, and use Water activity instruments in their testing protocols. It is Water activity measurements, not total Water content, that correlate to critical product quality attributes. The latest updated version of the proposed Chapter is available online via the US Pharmacopeia Forum (PF) [1]. The comment period for the proposed USP<922> General Chapter closed on 31-Mar-2020 and the official final Chapter is targeted to be published in USP-NF 2021 at the beginning of 2021.

total water content of 4% wt/wt but the highest water activity of 0.46 A w, will transfer water to the DCP which has the highest initial total water content of 21% wt/wt but the lowest initial water activity of 0.17 A w. Eventually, all compounds in the formulation will reach equilibrium and therefore have an identical final water activity.

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