Harmonization Status for General Chapters

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 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 has occurred.

USP Harmonization Status for General Chapters (as of 23-Feb-2024)
PDG# Method Name Coordinating Pharmacopeia PDG Current Official harmonization Sign-off Status Stage 4 Web* Posting Date(s)
G-01 Analytical Sieving: Rev 1 <786> USP S4 (Former S6), Rev.1, Corr. (15-Nov-2021) Stage 4 (Former Stage 6), 29-Apr-2022
G-02 Bulk Density of Powders <616> EP **S4 (Former S6), Rev. 4, Corr. 1 (24-Nov-2023) Stage 4 (Former Stage 6), 28-Apr-2023
G-03 Conductivity <644>, <1644> USP S4 (Former S6), Corr. 1, 02-Oct-2019 Stage 4 (Former Stage 6), 24-Apr-2020
G-04 Gas Pycnometric Density of Solids <699> EP S6 (8-May-2007) Link to posting and signoff history
G-05 Powder Flow <1174> USP S4 (Former S6), Rev. 1 (20-Jan-2023) Stage 4 (Former Stage 6), 28-Apr-2023
G-06 Tablet Friability <1216> USP S4 (Former S6), Rev.1 (07-Jun-2022) Stage 4 (Former Stage 6), 30-Sep-2022
G-07 Metal impurities <231><232><233> USP S3 N/A
G-08 Inhalation <601><1601> EP Suppressed from the PDG workplan. See the September 2017 PDG meeting highlights. N/A
G-09 Optical Microscopy <776> USP S6 (10-Jun-2004) Link to posting and signoff history
G-10 Powder Fineness <811> USP S6 (08-May-2007) Stage 6, 29-Apr-2011
G-11 Specific Surface Area <846> EP S6 (10-Nov-2003) Link to posting and signoff history
G-12 Porosimetry by Mercury Intrusion <267> EP S6 (08-May-2007) Stage 6, 29-Apr-2011
G-13 Laser Diffraction Measurement of Particle Size <429> EP S6 (11-Nov-2008) Link to posting and signoff history
G-14 X-Ray Powder Diffraction <941> EP S4 (Former S6), Rev. 1, 22-Dec-2020 Stage 4 (Former Stage 6), 30-Apr-2021
G-15 Water-Solid Interaction <1241> EP S6 (10-Sep-2002) Link to posting and signoff history
G-16 Thermal Analysis <891> EP S6, Rev.1S6 (26-Jun-2014) Link to posting and signoff history
G-17 Uniformity of Delivered Dose of Inhalations EP S2 N/A
G-18 Crystallinity Determination by Solution Calorimetry <696> EP S6 (16-Jun-2011) Stage 6, 29-Feb-2012
G-19 Density of Solids <699> EP S6 (03-Jun-2008) Link to posting and signoff history
G-20 Chromatography <621> EP S4 (Former S6), 28-Sep-2021 Stage 4 (Former Stage 6), 19-Nov-2021
G-21 Dynamic Light Scattering JP S4 (Former S6), Corr. 1, 14-Jun-2023 Stage 4 (Former Stage 6), 28-Apr2023