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 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 Chapters (as of 25-Apr-2025)
PDG#Method NameCoordinating PharmacopeiaPDG Current Official harmonization Sign-off StatusStage 4 Web* Posting Date(s)
G-01Analytical Sieving <786>USPS4 (Former S6), Rev.1, Corr. (15-Nov-2021)Stage 4 (Former Stage 6), 29-Apr-2022
G-02Bulk Density of Powders <616>EPS4 (Former S6), Rev. 4, Corr. 2 (18-Jun-2024)Stage 4 (Former Stage 6), 27-Sep-2024
G-03Conductivity <644>, <1644>USPS4 (Former S6), Corr. 1, 02-Oct-2019Stage 4 (Former Stage 6), 24-Apr-2020
G-04Gas Pycnometric Density of Solids <699>EPS6 (8-May-2007)Link to posting and signoff history
G-05Powder Flow <1174>USPS4 (Former S6), Rev. 1 (20-Jan-2023)Stage 4 (Former Stage 6), 28-Apr-2023
G-06Tablet Friability <1216>USPS4 (Former S6), Rev.1 (07-Jun-2022)Stage 4 (Former Stage 6), 30-Sep-2022
G-07Elemental Impurities <233>USPS4 (Former S6), 19-Jun-2024Stage 4 (Former Stage 6), 25-Apr-2025
G-08Inhalation <601><1601>EPSuppressed from the PDG workplan. See the September 2017 PDG meeting highlights.N/A
G-09Optical Microscopy <776>USPS6 (10-Jun-2004)Link to posting and signoff history
G-10Powder Fineness <811>USPS6 (08-May-2007)Stage 6, 29-Apr-2011
G-11Specific Surface Area <846>EPS6 (10-Nov-2003)Link to posting and signoff history
G-12Porosimetry by Mercury Intrusion <267>EPSuppressed from the PDG workplan. See the September 2017 PDG meeting highlights.Stage 6, 29-Apr-2011
G-13Laser Diffraction Measurement of Particle Size <429>EPS6 (11-Nov-2008)Link to posting and signoff history
G-14X-Ray Powder Diffraction <941>EPS4 (Former S6), Rev. 1, 22-Dec-2020Stage 4 (Former Stage 6), 30-Apr-2021
G-15Water-Solid Interaction <1241>EPS6 (10-Sep-2002)Link to posting and signoff history
G-16Thermal Analysis <891>EPS6, Rev.1 (26-Jun-2014)Link to posting and signoff history
G-17Uniformity of Delivered Dose of InhalationsEPSuppressed from the PDG workplan. See the September 2017 PDG meeting highlights.N/A
G-18Crystallinity Determination by Solution Calorimetry <696>EPSuppressed from the PDG workplan. See the September 2017 PDG meeting highlights.Stage 6, 29-Feb-2012
G-19Density of Solids <699>EPSuppressed from the PDG workplan. See the September 2017 PDG meeting highlights.USP-EP Bilateral Harmonization: Stage 4, 27-Sep-2024
G-20Chromatography <621>EPS4 (Former S6), 28-Sep-2021Stage 4 (Former Stage 6), 19-Nov-2021
G-21Dynamic Light Scattering <430>JPS4 (Former S6), Corr. 1, 14-Jun-2023Stage 4 (Former Stage 6), 28-Apr2023