USP Proposes Famotidine Monograph Revision Adding Dimaleate Salt Form for Related Compound B
Summary
USP's Small Molecules Therapeutic Areas 3 Committee proposes revising the Famotidine monograph to introduce the dimaleate salt form of USP Famotidine Related Compound B RS as an alternative to the current hygroscopic free base form. The revision also proposes adopting a two-table format for relative retention times and acceptance criteria, and referencing USP <477> User Determined Reporting Thresholds in the Organic Impurities test. Comments on the proposed Interim Revision Announcement are accepted through November 30, 2026.
“Comments were received indicating that the current free base form of USP Famotidine Related Compound B RS is difficult to handle due to its hygroscopic nature.”
About this source
GovPing monitors USP Compendial Notices for new healthcare & life sciences regulatory changes. Every update since tracking began is archived, classified, and available as free RSS or email alerts — 20 changes logged to date.
What changed
The proposed revision modifies the Famotidine monograph's USP Reference Standards <11> section to indicate that USP Famotidine Related Compound B RS may be available as either the free base or the dimaleate salt form, addressing material handling challenges. The monograph structure is also updated to include a two-table format for relative retention times and acceptance criteria, with new references to <477> User Determined Reporting Thresholds in the Organic Impurities test. Additional conforming changes align the monograph with current USP style conventions.\n\nAffected parties—drug manufacturers and quality control laboratories using Famotidine reference standards—should monitor the Pharmacopeial Forum 52(5) publication expected in September-October 2026 and prepare to submit comments by the November 30, 2026 deadline. Firms should review their current reference standard specifications and testing protocols against the proposed changes to assess any necessary updates to analytical procedures or documentation.
Archived snapshot
Apr 28, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Notice of Intent to Revise: Famotidine
Type of Posting: Notice of Intent to Revise
Posting Date: 24-Apr-2026
Targeted Official Date: 01-May-2027
Revision Vehicle: Interim Revision Announcement (IRA)
Expert Committee: Small Molecules Therapeutic Areas 3
In accordance with the Rules and Procedures of the Council of Experts, this is to provide notice that the Small Molecules Therapeutic Areas 3 intends to revise the Famotidine monograph.
Comments were received indicating that the current free base form of USP Famotidine Related Compound B RS is difficult to handle due to its hygroscopic nature. To address the comments, it is proposed to introduce the dimaleate salt form of this Reference standard, in addition to its base form, to address improved material handling. Accordingly, the USP Reference Standards <11> section is being revised to indicate that the USP Famotidine Related Compound B RS may be available either as the free base or as the dimaleate salt.
The committee also proposes introducing a two-table format style for relative retention times and acceptance criteria, and adding references to <477> User Determined Reporting Thresholds in the test for Organic Impurities. Additional changes are also proposed to update the monograph to the current USP style.
It is anticipated that the proposed revision will be published as an Interim Revision Announcement in Pharmacopeial Forum 52(5) [Sep.–Oct. 2026] pursuant to the Rules and Procedures. The comment period for this revision ends on November 30, 2026. In the absence of significant adverse comments, the proposed IRA will become official on May 1, 2027.
Should you have any questions, please contact Ramesh Muppa, Senior Scientist-II (ramesh.muppa@usp.org).
Named provisions
Related changes
Get daily alerts for USP Compendial Notices
Daily digest delivered to your inbox.
Free. Unsubscribe anytime.
About this page
Every important government, regulator, and court update from around the world. One place. Real-time. Free. Our mission
Source document text, dates, docket IDs, and authority are extracted directly from USP.
The summary, classification, recommended actions, deadlines, and penalty information are AI-generated from the original text and may contain errors. Always verify against the source document.
Classification
Who this affects
Taxonomy
Browse Categories
Get alerts for this source
We'll email you when USP Compendial Notices publishes new changes.
Subscribed!
Optional. Filters your digest to exactly the updates that matter to you.