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 4 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 Biotechnology (as of 28-Apr-2023)|
|PDG#||Method Name||Coordinating Pharmacopeia||PDG Current Official Harmonization Sign-off Status||Stage 4 Web* Posting Date(s)|
|B01||Amino Acid Determination <1052>||USP||S6 (28-Apr-2017)||Link to posting and signoff history|
|B02||Capillary Electrophoresis <1053>||EP||S6, Cor.2 (09-Jun-2010)||Link to posting and signoff history|
|B03||Isoelectric Focusing <1054>||EP||S6 (09-Sep-2002)||Link to posting and signoff history|
|B04||Protein Determination <1057>||USP||Suppressed from the PDG workplan. See the September 2017 PDG meeting highlights.||Link to posting and signoff history|
|B05||Peptide Mapping <1055>||USP||**S4 (Former S6), Rev. 1 (20-Jan-2023)||Link to posting and signoff history|
|B06||Polyacrylamide Gel Electrophoresis <1056>||EP||S6, Rev.1 (2014.06.26)||Stage 6, 21–Nov–2014|