Harmonization Status for Excipients

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 Excipients (as of 28-Feb-2017)
PDG# Monograph Name CP PDG Harmonization Status (Sign-off date) Stage 6 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.1
(27-Oct-2009)
Stage 6, 30-Nov-2012 (updated)
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)
To be posted
E21 Hypromellose JP S6, Rev.1, Corr.2
(01-JuL-2015)
Stage 6, 20-Nov-2015
E22 Hypromellose Phthalate USP S6
(06-Jun-2006)
Link to posting and sign-off history
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.2, Corr. 2
(01-Jul-2015)
Stage 6, 20–Nov–2015
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
(01-Jul-2015)
Stage 6, 20–Nov–2015
E33 Saccharin USP S6, Rev.1
(27-Jun-2013)
Stage 6, updated 18–Aug–2014 (updated)
E34 Saccharin Sodium USP S6, Rev. 2
(13-Nov-2014)
Stage 6, updated 29–Apr–2015
E35 Saccharin Calcium USP S6
(05-Feb-2003)
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

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