Harmonization Status for Biotechnology

The following table summarizes the sign-off and stage 6 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. These tables will be updated whenever a new Stage 6 is posted.

There are four categories of postings in the table column of Stage 6 Web* Posting Date(s):

  • If the Stage 6 is posted on the USP website with a history, it will link to the most recent web posting.
  • If the Stage 6 is posted on the USP website with no history, the most recent posting is updated with PDG sign-offs and Stage 6 postings, when available.
  • If the Stage 6 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."
USP Harmonization Status for Biotechnology (as of 28-Feb-2017)
PDG# Method Name CP PDG Current Official Harmonization Sign-off Status Stage 6 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 S6
(10-Sep-2002)
Link to posting and signoff history
B05 Peptide Mapping <1055> USP S6
(10-Sep-2002)
Link to posting and signoff history
B06 Polyacrylamide Gel Electrophoresis <1056> EP S6, Rev.1
(2014.06.26)
Stage 6, 21–Nov–2014

*Prior to 2011, the Stage 6 appeared in PF.