USP Seeks Submission of Proposals for Monograph Modernization

Updated:  November 28, 2011

The USP is continuously reviewing the Monograph Modernization List while also reviewing the remaining official USP–NF monographs for additional modernization opportunities. As a result of this effort, the Monograph Modernization List (downloadable spreadsheet) has been revised by moving monographs that are no longer considered to be a high priority to a separate tab within the spreadsheet labeled as “Small Molecules Inactive”.

USP’s strategy and prioritization criteria may evolve over time as a result of additional information and input from the FDA and stakeholders.  Additional procedures may be added to the Monograph Modernization List as the monograph modernization initiative progresses.

May 28, 2010

The USP is actively engaged in efforts to modernize official USP–NF monographs for small molecules and excipients that utilize outdated technology (e.g, use of packed gas chromatography columns), have safety/environmental concerns (e.g, chlorinated solvents, etc) or are missing procedures for key aspects such as impurities. For excipients, a major modernization goal is to replace relatively non-specific identification procedures with specific procedures (e.g, IR spectroscopy). To facilitate the modernization efforts, USP has identified and prioritized monographs in need of modernization and is seeking proposals to replace the current procedures or add procedures, as needed.

Monographs in need of modernization are presented in a downloadable spreadsheet that includes information on what procedure needs modernization and the current status of the modernization (separate tabs for small molecules and excipients). Some monographs have more than one procedure in need of modernization and each procedure is presented as a separate line item. In an effort to focus the modernization effort, the spreadsheet contains the top 200 small molecules monographs and 96 excipient monographs. There are more monographs in need of modernization and they will be added to the spreadsheet periodically as work progresses. Submissions for monograph modernizations that are not listed are also encouraged and can be submitted at anytime. The spreadsheet will be updated and posted on the USP website on a monthly basis on the last Friday of each month.

In order for USP to maintain consistency with FDA-approved control strategies, USP prefers to receive submissions from manufacturers of FDA-approved products (including drug substances and excipients that are known to be used in FDA-approved products) or manufacturers intending to seek FDA approval. The latter category of submissions will be initially considered for publication as a Pending standard (see USP Pending Monograph Guidelines). Submissions, especially new impurity procedures, from other sources (e.g., contract laboratories, academic institutions, analytical instrumentation/equipment manufacturers) can be accepted on a case-by-case basis and should follow ICH Q3 guidelines. All submissions should include data and other information recommended in USP’s Guideline for Submission of Request for Revision to USP–NF. Please review the USP Submission Checklist for data and information that should be included in the submission. Some modernization proposals may generate new USP Reference Standards and USP invites the sponsor of the proposal to donate the necessary bulk reference materials. For more information, please review the USP Guideline for Suppliers of Reference Standard Materials.

Small Molecules and Excipients Monographs Needing Modernization

Posting Date: 27–Apr–2012

For questions regarding the Monograph Modernization List, please contact:
Morgan L. Puderbaugh
Associate Scientific Liaison, Small Molecules
mxp@usp.org; 301-998-6833

Next Posting Date: 25–May–2012