USP Seeks Submission of Proposals for Monograph Modernization
To continue to provide high-quality public standards, USP is modernizing many existing monographs across our compendia. We seek industry collaborators to assist in this effort.
USP intends to modernize these monographs as soon as possible via traditional submission (e.g. manufacturer of article) or USP’s internal laboratory efforts.
USP would like to receive submissions for monographs denoted as “High Priority” within 90 days of the high priority designation. “High Priority” monographs for which USP does not receive submissions may be directed to our laboratory for development.
Ways in which you may help include:
- Submitting your current analytical procedure and supporting validation data
- Providing the names of impurities and FDA-approved acceptance criteria to be incorporated into the modernization revision developed by USP’s internal labs
- Providing sample amounts of the article for USP’s internal lab development.
For more information, visit our Key Issue: Monograph Modernization page.
Select the below link to view chemical medicines and excipients monographs requiring modernization:email@example.com.