USP: <11> Reference Standards - Draft published for Comment

The new draft of the monograph "<11> USP REFERENCE STANDARDS" has been published for comment on the website of the USP Pharmacopeial Forum since the beginning of May 2024. Comments and adjustments on this summary can be submitted until 31 July 2024.

This draft is based on the current version of the chapter, which has been in force since 1st November 2020. In addition to the formal adjustments, changes and updates have been made in almost all passages of the monograph. These are listed below:

  • Introduction
  • Establishment Approaches and Value Assignment
  • USP Reference Standards for USP or NF
  • Labeling
  • Storage
  • Valid Use Date
  • Proper Use

Except for the paragraph "USP REFERENCE STANDARDS FOR OTHER MEASUREMENTS AND DETERMINATIONS", no adjustments or deletions were made.
Most of the changes and updates to the above-mentioned passages are based on the fact that the so-called "USP digital Reference Standards (dRS)" have been included and integrated into the chapter.

You can access and comment on the new draft of the monograph "<11> USP REFERENCE STANDARDS" after registering once on the Pharmacopeial Forum website.

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