Harmonization Status for General Methods

Please see recent Pharmacopeial Discussion Group Working Procedures Changes here effective April 1, 2018.

 

The following table summarizes the sign-off and stage 4 posting status for all monographs and general chapters under the Pharmacopeial Discussion Group (PDG) work plan. Please note the Stage 6 postings appeared in PF prior to 2011 and Effective April 1, 2018, PDG will utilize a reduced 5-stage approach for harmonization. These tables will be updated whenever a new Stage 4 is posted.

There are four categories of postings in the table column of Stage 4 Web* Posting Date(s):

  • If the Stage 4 is posted on the USP website with a history, it will link to the most recent web posting.
  • If the Stage 4 is posted on the USP website with no history, the most recent posting is updated with PDG sign-offs and Stage 4 postings, when available.
  • If the Stage 4 was published in Pharmacopeial Forum (PF) previously with no web postings at all, a new web page is created for that monograph with a summary of previous PDG sign-offs and PF postings, when available.
  • If the monograph has not been signed off, it is labeled “N/A."

*Prior to 2011, the Stage 6 appeared in PF. Effective April 1, 2018, PDG will utilize a reduced 5-stage approach for harmonization.

**This PDG sign-off document contains text that is not USP-NF official text. Text in PDG sign-off documents must be balloted on and approved by the assigned expert committee(s) before it can be converted to USP-NF official text. The Stage 4 Web Posting Date(s) link will be updated when this occurs.

USP Harmonization Status for General Methods (as of 9-Jun-2025)
PDG#Method NameCoordinating PharmacopeiaPDG Harmonization Sign-off StatusStage 4 Web* Posting Date(s)
Q-01Dissolution <711>USPS6, Rev.3(10-Jun-2010)Stage 6, 25–Feb–2011 (updated)
Q-02Disintegration <701>USPS6, Rev.1, Corr.1(03-Oct-2018)Link to posting and signoff history
Q-03/04Uniformity of Content/Mass <905>USPS4 (Former S6), Rev. 2 (04-Nov-2015)Stage 4 (Former Stage 6), (30-Sep-2022)
Q-05aTests for Specified Microorganism <62>EPS6, Rev.1(05-Jun-2008)Link to posting and signoff history
Q-05bMicrobial Enumeration: <61>EPS4 (Former S6), Rev. 1, Corr. 2 (22-Aug-2023)Stage 4 (Former Stage 6), 26-Apr-2024
Q-05cLimits for Non-Sterile Products <1111>EPS6, Revision of sign-off cover sheet(27-Jun-2013)Link to posting and signoff history
Q-06Bacterial Endotoxins <85>JPS6, Rev.2(16-Jun-2011)Stage 6, 23–Nov–2011 (updated)
Q-07Color (instrumental method) <1061>EPS6(26-Oct-2016)Link to posting and signoff history
Q-08Extractable Volume <1>EPS6, update to Rev. 1 for USP local requirements(09-Nov-2010)Link to posting and signoff history
Q-09Particulate Contamination <788>EP**S4 (Former S6), Rev. 2 (02-May-2025)Link to posting and signoff history
Q-10Residue on Ignition <281>JPS6, Rev.2(04-Aug-2005)Link to posting and signoff history
Q-11Sterility Test <71>EPS6, Rev.1, Corr.3(10-Jun-2009)Link to posting and signoff history