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.
| USP Harmonization Status for General Chapters (as of 19-Nov-2021) | ||||
|---|---|---|---|---|
| PDG# | Method Name | CP | PDG Current Official harmonization Sign-off Status | Stage 4 Web* Posting Date(s) |
| G01 | Analytical Sieving: Rev 1 <786> | USP | S6, Rev.1 (08-May-2007) | Link to posting and signoff history |
| G02 | Bulk Density and Tapped Density <616> | EP | S6, Rev.3 (06-Nov-2013) | Stage 6, 26-Sep-2014 |
| G03 | Conductivity <644>, <1644> | USP | S4 (Former S6), Corr. 1, 02-Oct-2019 | Stage 4 (Former Stage 6), 24-Apr-2020 |
| G04 | Gas Pycnometric Density of Solids <699> | EP | S6 (8-May-2007) | Link to posting and signoff history |
| G05 | Powder Flow <1174> | USP | S6 (10-Jun-2004) | Link to posting and signoff history |
| G06 | Tablet Friability <1216> | USP | S6 (18-Feb-2004) | Link to posting and signoff history |
| G07 | Metal impurities <231><232><233> | USP | S3 | N/A |
| G08 | Inhalation <601><1601> | EP | Suppressed from the PDG workplan. See the September 2017 PDG meeting highlights. | N/A |
| G09 | Optical Microscopy <776> | USP | S6 (10-Jun-2004) | Link to posting and signoff history |
| G10 | Powder Fineness <811> | USP | S6 (08-May-2007) | Stage 6, 29-Apr-2011 |
| G11 | Specific Surface Area <846> | EP | S6 (10-Nov-2003) | Link to posting and signoff history |
| G12 | Porosimetry by Mercury Intrusion <267> | EP | S6 (08-May-2007) | Stage 6, 29-Apr-2011 |
| G13 | Laser Diffraction Measurement of Particle Size <429> | EP | S6 (11-Nov-2008) | Link to posting and signoff history |
| G14 | X-Ray Powder Diffraction <941> | EP | S4 (Former S6), Rev. 1, 22-Dec-2020 | Stage 4 (Former Stage 6), 30-Apr-2021 |
| G15 | Water-Solid Interaction <1241> | EP | S6 (10-Sep-2002) | Link to posting and signoff history |
| G16 | Thermal Analysis <891> | EP | S6, Rev.1S6 (26-Jun-2014) | Link to posting and signoff history |
| G17 | Uniformity of Delivered Dose of Inhalations | EP | S2 | N/A |
| G18 | Crystallinity Determination by Solution Calorimetry <696> | EP | S6 (16-Jun-2011) | Stage 6, 29-Feb-2012 |
| G19 | Density of Solids <699> | EP | S6 (03-Jun-2008) | Link to posting and signoff history |
| G20 | Chromatography <621> | EP | S4 (Former S6), 28-Sep-2021 | Stage 4 (Former Stage 6), 28-Sep-2021 |
| G21 | Dynamic Light Scattering | JP | S3 | N/A |