Harmonization Status for Excipients

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.

USP Harmonization Status for Excipients (as of 27-Apr-2018)
PDG# Monograph Name CP PDG Harmonization Status (Sign-off date) Stage 4 Web* Posting Date(s)
E01 Alcohol EP S6, Rev.2, Corr.2
(26-Jun-2014)
Stage 6
21–Nov–2014 (updated)
E02 Dehydrated Alcohol EP S6, Rev.2, Corr.2
(26-Jun-2014)
Stage 6
21–Nov–2014 (updated)
E03 Benzyl Alcohol EP S6, Correction to Rev. 2
(15-Jun-2011)
Stage 6
23-Nov-2011(updated)
E04 Calcium Disodium Edetate JP S6
(08-Nov-2005)
Link to posting and sign-off history
E05 Calcium Phosphate Dibasic JP S6, Rev.1
(15-Jun-2011)
Link to posting and sign-off history
E06 Calcium Phosphate Dibasic Anhydrous JP S6, Rev.1
(15-Jun-2011)
Link to posting and sign-off history
E07 Carmellose Calcium (Carboxymethylcellulose Calcium) USP S6, Rev.1
(17-Jul-2003)
Link to posting and sign-off history
E08 Carmellose Sodium USP S3 N/A
E09 Croscarmellose Sodium USP S6, Rev. to sign-off cover page
(26-May-2016)
Link to posting and sign-off history
E10 Microcrystalline Cellulose USP S6, Rev. to Rev.1 sign-off cover page
(26-May-2016)
Link to posting and sign-off history
E11 Cellulose, Powdered USP S6, Rev. to Rev.1 sign-off cover page
(26-May-2016)
Link to posting and sign-off history
E12 Cellulose Acetate USP S6, Rev.3
(26-May-2016)
Stage 6, 30–Sep–2016 (updated)
E13 Cellulose Acetate Phthalate (Cellacefate) USP S6, Rev.1
(09-Nov-2010)
Stage 6, updated 27-Apr-2012 (updated)
E14 Citric Acid, Anhydrous EP S6, Rev.2(09-Jun-2010) Stage 6, updated 14-Oct-2011 (updated)
E15 Citric Acid, Monohydrate EP S6, Rev.2
(10-Jun-2010)
Stage 6, updated 14-Oct-2011 (updated)
E16 Crospovidone EP S6
(09-Nov-2010)
Stage 6, 25-Feb-2011 (updated)
E17 Ethylcellulose EP S6, Rev.2
(26-May-2016)
Stage 6, 29-Sep-2017
E18 Hydroxyethyl Cellulose EP S6
(25-Jul-2016)
Link to posting and sign-off history
E19 Hydroxypropyl Cellulose USP S6
(27-Jun-2013)
Stage 6, 28-Feb-2014 (updated)
E20 Low-Substituted Hydroxypropyl Cellulose USP S6, Corr.2
(26-Oct-2016)
Stage 4 (Former Stage 6), 27-Apr-2018
E21 Hypromellose JP S6, Rev.2
(13-Sep-2017)
Stage 4 (Former Stage 6), 27-Apr-2018
E22 Hypromellose Phthalate USP S6
(06-Jun-2006)
Stage 4 (Former Stage 6), 27-Apr-2018
E23 Anhydrous Lactose EP S6, Rev. of Rev. 4 sign-off cover sheet
(26-Oct-2016)
Stage 6, 29–Feb–2012 (updated)
E24 Lactose Monohydrate USP S6, Rev.2
(05-Jun-2008)
Stage 6, updated 14-Oct-2011 (updated)
E25 Magnesium Stearate USP S6, Corr.3
(27-Jun-2013)
Stage 6, 25–Sep–2015
E26 Methylcellulose JP S6, Rev.3 (13-Sep-2017) Stage 4 (Former Stage 6), 27–Apr–2018
E27 Methylparaben EP S6, Rev. 1 Corr
(09-Nov-2011)
Link to posting and sign-off history
E28 Petrolatum USP S4 N/A
E29 Petrolatum, White USP S4 N/A
E30 Polyethylene Glycol USP S4 N/A
E31 Polysorbate 80 EP S6, Rev.1, Corr.3
(01-Jul-2016)
Stage 6, 30-Sep-2016
E32 Povidone JP S6, Rev. 1, Corr. 1
(04-Nov-2015)
Stage 4 (Former Stage 6), 27–Apr–2018
E33 Saccharin USP Suppressed from the PDG workplan. See the September 2017 PDG meeting highlights. Stage 6, updated 18–Aug–2014 (updated)
E34 Saccharin Sodium USP Suppressed from the PDG workplan. See the September 2017 PDG meeting highlights. Stage 6, updated 29–Apr–2015
E35 Saccharin Calcium USP Suppressed from the PDG workplan. See the September 2017 PDG meeting highlights. Link to posting and sign-off history
E36 Silicon Dioxide JP S4 N/A
E37 Silicon Dioxide, Colloidal JP S4 N/A
E38 Sodium Chloride EP S6, Rev.3
(06-Nov-2013)
Stage 6, 20–Nov–2015
E39 Sodium Starch Glycolate USP S6, Rev.3
(27-Jun-2013)
Stage 6, 28-Feb-2014 (updated)
E40 Starch, Corn USP S6, Rev.3
(06-Jun-2012)
Stage 6, updated 26-Jul-2013 (updated)
E41 Starch, Potato EP S6, Rev.2
(15-Jun-2011)
Stage 6, 29-Feb-2012 (updated)
E42 Starch, Rice EP S6, Rev.1
(06-Nov-2013)
Stage 6, 26–Sep–2014
E43 Starch, Wheat EP S6, Revision on Rev. 2 sign-off cover sheet
(04-Nov-2015)
Stage 6, 29-Feb-2012 (updated)
E44 Stearic Acid EP S6, Rev.1, Corr.1
(13-Nov-2014)
Stage 6, updated 29–Apr–2015
E45 Sucrose EP S6, sign-off cover sheet revision
(27-Jun-2013)
Stage 6, updated 28-Mar-2014
E46 Talc EP S6, Rev.1
(03-Jun-2008)
Revision Bulletin: 30-Jun-2011 (updated)
E48 Ethylparaben JP S6, Rev. 1, Corr.
(09-Nov-2011)
Link to posting and sign-off history
E49 Propylparaben JP S6, Rev. 1, Corr.
(09-Nov-2011)
Link to posting and sign-off history
E50 Butylparaben EP S5B, Rev.1
(09-Jun-2010)
Stage 6, Updated 11-Feb-2013 (updated)
E51 Glycerin USP S3 N/A
E52 Carmellose JP S6, Rev.1
(09-Nov-2011)
Link to posting and sign-off history
E53 Calcium Carbonate JP S4 N/A
E54 Copovidone JP S4 N/A
E55a Gelatin, gelling type EP S6, Corr.2
(26-Jun-2014)
Stage 6, 25–Sep–2015
E55b Gelatin, non-gelling grade EP
E56 Glucose Monohydrate/Anhydrous (Dextrose) EP S6, Rev.1
(04-Nov-2015)
Stage 6, 20-Nov-2015
E58 Mannitol EP S6, Corr.1
(26-Jun-2014)
Stage 6, 26-Sep-2014
E59 Propylene Glycol EP S4 N/A
E60 Sodium Lauryl Sulfate USP S6
(13-Nov-2014)
Stage 6, updated 29–Apr–2015
E61 Starch, Pregelatinized JP S3 N/A
E62 SWFI in Containers USP S4 N/A
E63 Lactose in Inhalation USP S3 N/A
E64 Isomalt EP S6
(27-Jun-2013)
Stage 6, 25–Sep–2015
E65 Isostearyl Alcohol JP S1 N/A
E66 Myristyl Myristate JP S1 N/A
E67 Sodium Cetyl Sulfate JP S1 N/A
E68 Polysorbate 65 JP S1 N/A
E69 Calcium Silicate JP S1 N/A