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.

USP Harmonization Status for General Chapters (as of 27-Apr-2018)
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 N/A
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 S6
(30-Oct-2007)
Link to posting and signoff history
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 N/A
G21 Dynamic Light Scattering JP S3 N/A