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Changes to USP's Description and Relative Solubility Reference Table

Type of Posting: Notice of Intent to Revise
Posting Date: 30–Sept–2022
Targeted Official Date: 1–May–2023
Expert Committee: Various

In accordance with the Rules and Procedures of the Council of Experts, this is to provide notice that USP intends to revise the Description and Relative Solubility of USP and NF Articles Reference Table. Please see the Notice of Intent to Revise that published June 24, 2022 for background information.

In USP–NF 2023, Issue 1, USP intends to remove entries pertaining to omitted monographs or those with no monograph association from the Reference Table. It is anticipated that the updated Reference Table will be published on November 1, 2022 and become official on May 1, 2023. A list of entries planned for deletion can be found here.

In Pharmacopeial Forum 48(6) [Nov-Dec 2022], USP plans to further revise the Reference Table to remove the entries for drug substances and legacy entries for drug products and provide external links where description and solubility information for drug substances can be obtained as a part of FDA-approved labels. Because there are no external sources of information for Excipients and Dietary Ingredients which are comparable to the sources of description and solubility information in FDA-approved labels, USP will continue to update and publish description and solubility information for these types of substances. The updated table is targeted to appear in USP-NF 2024, Issue 1 with an official date of May 1, 2024.

Should you have any questions, please contact Sujatha Ramakrishna, Senior Principal Scientist (sxr@usp.org).


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