Water Activity | USP 795 & 797 Revisions

by | Jun 21, 2023

The new practice of using water activity as a tool for establishing the BUD of a CNSP is described in Section 10.3 of the to-be-official USP <795> chapter. Water activity testing in accordance with USP <922> is not required but is highly recommended to support the established BUD of the CNSP.  Water activity testing should be considered in cases where there is an absence of a USP-NF Compounded Preparation Monograph and/or CNSP-specific stability information.

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