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 22-Nov-2024) | ||||
|---|---|---|---|---|
| PDG# | Method Name | Coordinating Pharmacopeia | PDG Harmonization Sign-off Status | Stage 4 Web* Posting Date(s) |
| Q-01 | Dissolution <711> | USP | S6, Rev.3(10-Jun-2010) | Stage 6, 25–Feb–2011 (updated) |
| Q-02 | Disintegration <701> | USP | S6, Rev.1, Corr.1(03-Oct-2018) | Link to posting and signoff history |
| Q-03/04 | Uniformity of Content/Mass <905> | USP | S4 (Former S6), Rev. 2 (04-Nov-2015) | Stage 4 (Former Stage 6), (30-Sep-2022) |
| Q-05a | Tests for Specified Microorganism <62> | EP | S6, Rev.1(05-Jun-2008) | Link to posting and signoff history |
| Q-05b | Microbial Enumeration: <61> | EP | S4 (Former S6), Rev. 1, Corr. 2 (22-Aug-2023) | Stage 4 (Former Stage 6), 26-Apr-2024 |
| Q-05c | Limits for Non-Sterile Products <1111> | EP | S6, Revision of sign-off cover sheet(27-Jun-2013) | Link to posting and signoff history |
| Q-06 | Bacterial Endotoxins <85> | JP | S6, Rev.2(16-Jun-2011) | Stage 6, 23–Nov–2011 (updated) |
| Q-07 | Color (instrumental method) <1061> | EP | S6(26-Oct-2016) | Link to posting and signoff history |
| Q-08 | Extractable Volume <1> | EP | S6, update to Rev. 1 for USP local requirements(09-Nov-2010) | Link to posting and signoff history |
| Q-09 | Particulate Contamination <788> | EP | S6, Rev.1(06-Jun-2012) | Link to posting and signoff history |
| Q-10 | Residue on Ignition <281> | JP | S6, Rev.2(04-Aug-2005) | Link to posting and signoff history |
| Q-11 | Sterility Test <71> | EP | S6, Rev.1, Corr.3(10-Jun-2009) | Link to posting and signoff history |