Harmonization Status for General Methods

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 Methods (as of 27-Apr-2018)
PDG# Method Name CP PDG Harmonization Sign-off Status Stage 4 Web* Posting Date(s)
Q01 Dissolution <711> USP S6, Rev.3(10-Jun-2010) Stage 6, 25–Feb–2011 (updated)
Q02 Disintegration <701> USP S6, Rev.1(30-Oct-2007) Link to posting and signoff history
Q03/04 Uniformity of Content/Mass <905> USP S6, Rev.1(09-Nov-2010) Stage 6, 25–Feb–2011 (updated)
Q05a Tests for Specified Microorganism <62> EP S6, Rev.1(05-Jun-2008) Link to posting and signoff history
Q05b Microbial Enumeration: <61> EP S6, Rev. 1 Corr. 1(10-Jun-2009) Link to posting and signoff history
Q05c Limits for Non-Sterile Products <1111> EP S6, Revision of sign-off cover sheet(27-Jun-2013) Link to posting and signoff history
Q06 Bacterial Endotoxins <85> JP S6, Rev.2(16-Jun-2011) Stage 6, 23–Nov–2011 (updated)
Q07 Color (instrumental method) <1061> EP S6(26-Oct-2016) Link to posting and signoff history
Q08 Extractable Volume <1> EP S6, update to Rev. 1 for USP local requirements(09-Nov-2010) Link to posting and signoff history
Q09 Particulate Contamination <788> EP S6, Rev.1(06-Jun-2012) Link to posting and signoff history
Q10 Residue on Ignition <281> JP S6, Rev.2(04-Aug-2005) Link to posting and signoff history
Q11 Sterility Test <71> EP S6, Rev.1, Corr.3(10-Jun-2009) Link to posting and signoff history