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.
*** Item had an incorrect original posting date of September 26, 2023, and was corrected to November 17, 2023
| USP Harmonization Status for Excipients (as of 23-Feb-2024) | ||||
|---|---|---|---|---|
| PDG# | Monograph Name | Coordinating Pharmacopeia | PDG Harmonization Status (Sign-off date) | Stage 4 Web* Posting Date(s) |
| E-01 | Alcohol | EP | S6, Rev.2, Corr.2 (26-Jun-2014) | Stage 6, 21–Nov–2014 (updated) |
| E-02 | Dehydrated Alcohol | EP | S6, Rev.2, Corr.2 (26-Jun-2014) | Stage 6, 21–Nov–2014 (updated) |
| E-03 | Benzyl Alcohol | EP | S4 (Former S6), Corr. 2 to Rev. 2, 22-Dec-2020 | Stage 4 (Former Stage 6), 22-Dec-2020 |
| E-04 | Calcium Disodium Edetate | JP | S6 (08-Nov-2005) | Link to posting and sign-off history |
| E-05 | Calcium Phosphate Dibasic | JP | S6, Rev.1 (15-Jun-2011) | Link to posting and sign-off history |
| E-06 | Calcium Phosphate Dibasic Anhydrous | JP | S4, Rev 2 13-Sep-2017 | Stage 4 (Former Stage 6), 30-Nov-2018 |
| E-07 | Carmellose Calcium (Carboxymethylcellulose Calcium) | USP | S4 (Former S6), Rev.1, Corr.1 (20-Jan-2023) | Stage 4 (Former Stage 6), 17-Nov-2023*** |
| E-08 | Carmellose Sodium | USP | S3 | N/A |
| E-09 | Croscarmellose Sodium | USP | S4 (Former S6), Rev. 1, 22-Dec-2020 | Stage 4 (Former Stage 6), 30-Apr-2021 |
| E-10 | Microcrystalline Cellulose | USP | S4, Rev 3 03-Oct-2018 | Stage 4 (Former Stage 6), 30-Nov-2018 |
| E-11 | Cellulose, Powdered | USP | S4 (Former S6), Rev.1, Corr. (15-Nov-2021) | Stage 4 (Former Stage 6), 29-Apr-2022 |
| E-12 | Cellulose Acetate | USP | Suppressed from the PDG workplan. See the September 2017 PDG meeting highlights. | Stage 6, 30–Sep–2016 (updated) |
| E-13 | Cellulose Acetate Phthalate (Cellacefate) | USP | S6, Rev.1 (09-Nov-2010) | Stage 6, updated 27-Apr-2012 (updated) |
| E-14 | Citric Acid, Anhydrous | EP | S6, Rev.2 (09-Jun-2010) | Stage 6, updated 14-Oct-2011 (updated) |
| E-15 | Citric Acid, Monohydrate | EP | S6, Rev.2 (10-Jun-2010) | Stage 6, updated 14-Oct-2011 (updated) |
| E-16 | Crospovidone | EP | S6 (09-Nov-2010) | Stage 6, 25-Feb-2011 (updated) |
| E-17 | Ethylcellulose | EP | S6, Rev.2 (26-May-2016) | Stage 6, 29-Sep-2017 |
| E-18 | Hydroxyethyl Cellulose | EP | S6 (25-Jul-2016) | Stage 4 (Former Stage 6), 27-Sep-2019 |
| E-19 | Hydroxypropyl Cellulose | USP | S6 (27-Jun-2013) | Stage 6, 28-Feb-2014 (updated) |
| E-20 | Low-Substituted Hydroxypropyl Cellulose | USP | S4 (Former S6), Corr. 3 (20-Jan-2023) | Stage 4 (Former Stage 6), 17-Nov-2023*** |
| E-21 | Hypromellose | JP | S4 (Former S6), Rev. 2, Corr.1 (20-Jan-2023) | Stage 4 (Former Stage 6), 17-Nov-2023*** |
| E-22 | Hypromellose Phthalate | USP | S4 (Former S6), Corr. 1 (15-Nov-2021) | Stage 4 (Former Stage 6), 29-Apr-2022 |
| E-23 | Anhydrous Lactose | EP | S4 (Former S6), Rev.4, Corr.2 (20-Jan-2023) | Stage 4 (Former Stage 6), 17-Nov-2023 |
| E-24 | Lactose Monohydrate | USP | S4 (Former S6), Rev.2, Corr.2 (20-Jan-2023) | Stage 4 (Former Stage 6), 17-Nov-2023 |
| E-25 | Magnesium Stearate | USP | S6, Corr.3 (27-Jun-2013) | Stage 6, 25–Sep–2015 |
| E-26 | Methylcellulose | JP | S4 (Former S6), Rev. 3, Corr. 1 (20-Jan-2023) | Stage 4 (Former Stage 6), 17-Nov-2023*** |
| E-27 | Methylparaben | EP | S6, Rev. 1 Corr (09-Nov-2011) | Link to posting and sign-off history |
| E-28 | Petrolatum | USP | **S4 (Former S6) (15-Nov-2021) | Link to posting and signoff history |
| E-29 | Petrolatum, White | USP | **S4 (Former S6) (15-Nov-2021) | Link to posting and signoff history |
| E-30 | Polyethylene Glycol | USP | S4 | N/A |
| E-31 | Polysorbate 80 | EP | S6, Rev.1, Corr.3 (01-Jul-2016) | Stage 6, 30-Sep-2016 |
| E-32 | Povidone | JP | S6, Rev. 1, Corr. 1 (04-Nov-2015) | Stage 4 (Former Stage 6), 27–Apr–2018 |
| E-33 | Saccharin | USP | Suppressed from the PDG workplan. See the September 2017 PDG meeting highlights. | Stage 6, updated 18–Aug–2014 (updated) |
| E-34 | Saccharin Sodium | USP | Suppressed from the PDG workplan. See the September 2017 PDG meeting highlights. | Stage 6, updated 29–Apr–2015 |
| E-35 | Saccharin Calcium | USP | Suppressed from the PDG workplan. See the September 2017 PDG meeting highlights. | Link to posting and sign-off history |
| E-36 | Silicon Dioxide | JP | S4 | N/A |
| E-37 | Silicon Dioxide, Colloidal | JP | S4 | N/A |
| E-38 | Sodium Chloride | EP | S6, Rev.3 (06-Nov-2013) | Stage 6, 20–Nov–2015 |
| E-39 | Sodium Starch Glycolate | USP | S6, Rev.3 (27-Jun-2013) | Stage 6, 28-Feb-2014 (updated) |
| E-40 | Starch, Corn | USP | S6, Rev.3 (06-Jun-2012) | Stage 6, updated 26-Jul-2013 (updated) |
| E-41 | Starch, Potato | EP | S6, Rev.2 (15-Jun-2011) | Stage 6, 29-Feb-2012 (updated) |
| E-42 | Starch, Rice | EP | S6, Rev.1 (06-Nov-2013) | Stage 6, 26–Sep–2014 |
| E-43 | Starch, Wheat | EP | S4 (Former S6), Corr. 1 to Rev. 3, 22-Dec-2020 | Stage 4 (Former Stage 6), 30-Apr-2021 |
| E-44 | Stearic Acid | EP | S4 (Former S6), Rev.2 (15-Nov-2021) | Stage 4 (Former Stage 6), 30-Sep-2022 |
| E-45 | Sucrose | EP | S6, sign-off cover sheet revision (27-Jun-2013) | Stage 6, updated 28-Mar-2014 |
| E-46 | Talc | EP | S6, Rev.1 (03-Jun-2008) | Revision Bulletin: 30-Jun-2011 (updated) |
| E-48 | Ethylparaben | JP | S6, Rev. 1, Corr. (09-Nov-2011) | Link to posting and sign-off history |
| E-49 | Propylparaben | JP | S6, Rev. 1, Corr. (09-Nov-2011) | Link to posting and sign-off history |
| E-50 | Butylparaben | EP | S5B, Rev.1 (09-Jun-2010) | Stage 6, Updated 11-Feb-2013 (updated) |
| E-51 | Glycerin | USP | S3 | N/A |
| E-52 | Carmellose | JP | S6, Rev.1 (09-Nov-2011) | Link to posting and sign-off history |
| E-53 | Calcium Carbonate | JP |
Suppressed from the PDG workplan. See the September 2017 PDG meeting highlights. |
N/A |
| E-54 | Copovidone | JP | S4 (Former S6), Corr. 1, 02-Oct-2019 | Stage 4 (Former Stage 6), 24-Apr-2020 |
| E-55a | Gelatin, gelling type | EP | S6, Rev.2 (03-Oct-2018) | Stage 4 (Former Stage 6), 26-Apr-2019 |
| E-55b | Gelatin, non-gelling grade | EP | ||
| E-56 | Glucose Monohydrate/Anhydrous (Dextrose) | EP | S6, Rev.1 (04-Nov-2015) | Stage 6, 20-Nov-2015 |
| E-58 | Mannitol | EP | S6, Corr.1 (26-Jun-2014) | Stage 6, 26-Sep-2014 |
| E-59 | Propylene Glycol | EP | S4 | N/A |
| E-60 | Sodium Lauryl Sulfate | USP | S4 (Former S6), Rev. 1, 02-Oct-2019 | Stage 4 (Former Stage 6), 24-Apr-2020 |
| E-61 | Starch, Pregelatinized | JP | S3 | N/A |
| E-62 | SWFI in Containers | USP | S4 | N/A |
| E-63 | Lactose in Inhalation | USP | Suppressed from the PDG workplan. See the October 2018 PDG meeting highlights. | N/A |
| E-64 | Isomalt | EP | S6 (27-Jun-2013) | Stage 6, 25–Sep–2015 |
| E-65 | Isostearyl Alcohol | JP | S1 | N/A |
| E-66 | Myristyl Myristate | JP | S1 | N/A |
| E-67 | Sodium Cetyl Sulfate | JP | Suppressed from the PDG workplan. See the October 2018 PDG meeting highlights. | N/A |
| E-68 | Polysorbate 65 | JP | S1 | N/A |
| E-69 | Calcium Silicate | USP | S1 | N/A |
| E-70 | Polysorbate 20 | USP | S1 | N/A |
| E-71 | Purified Water | USP | S1 | N/A |
| E-72 | Water for Injection | USP | S1 | N/A |