USP Notice: Revision to Guaifenesin, Pseudoephedrine HCL, Dextromethorphan Capsules Monograph

USP Compendial Notices

Published February 27th, 2026

Detected March 12th, 2026

Summary

The United States Pharmacopeia (USP) has issued a notice of intent to revise the monograph for Guaifenesin, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Capsules. The revision aims to update a cross-reference to an omitted monograph and incorporate the full text of a previously official assay procedure.

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What changed

The United States Pharmacopeia (USP) Small Molecules 2 Expert Committee intends to revise the monograph for Guaifenesin, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Capsules. This revision is prompted by comments indicating that the Assay for Guaifenesin procedure incorrectly cross-references a previously omitted monograph. The proposed change involves incorporating the full text of the Assay for Guaifenesin procedure from the former Guaifenesin and Pseudoephedrine Hydrochloride Capsules monograph into the current one.

This is a notice of intent to revise, and the exact publication date is to be determined. Regulated entities, particularly drug manufacturers, should monitor the USP's official publications for the final revised monograph. No immediate compliance actions are required, but awareness of the upcoming change to the official assay procedure is recommended.

What to do next

Monitor USP publications for the final revised monograph.

Source document (simplified)

Guaifenesin, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Capsules

Type of Posting: Notice of Intent to Revise
Posting Date: 27-Feb-2026
Targeted Official Date: TBD
Expert Committee: Small Molecules 2

In accordance with the Rules and Procedures of the Council of Experts, this is to provide notice that the Small Molecules 2 Expert Committee intends to revise the Guaifenesin, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Capsules monograph.

Comments were received indicating that the Assay for Guaifenesin procedure in the Guaifenesin, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Capsules monograph cross-references the previously official Guaifenesin and Pseudoephedrine Hydrochloride Capsules monograph, which has since been omitted. The Expert Committee is proposing to update this monograph and add the full text of the previously official Assay for Guaifenesin procedure (Guaifenesin and Pseudoephedrine Hydrochloride Capsules) to the Guaifenesin, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Capsules monograph.

It is anticipated that the proposed revision will be published using a suitable revision vehicle pursuant to the Rules and Procedures, at a date to be determined. Should you have any questions, please contact Sabrina Cusick, Senior Pharmacopeial Specialist (sabrina.cusick@usp.org).