The following table provides useful information about all the monographs of excipients on the Pharmacopoeial Discussion Group (PDG) work plan. It also includes the sign-off coversheets and, as of December 2020, the full PDG sign-off texts. The coversheets provide detailed helpful information about harmonised parts and local requirements for all individual texts having undergone harmonisation by the PDG. Information is updated after each PDG meeting.

 

PH. EUR. HARMONISATION STATUS FOR EXCIPIENTS (as of 1 May 2025)

PDG Monograph name
(PDG#)

Ph. Eur. Monograph
name (Ph. Eur. number)

Co-ordinating pharmacopoeia

Latest harmonised version

Sign-off
document

Ongoing work

Alcohol (E-01)

Ethanol (96 per cent) (1317)

Ph. Eur.

Correction of the sign-off cover sheet Revision 2 Correction 2

E01_Rev2_Corr2_Corr_cover_sheet_2021_10_Sign-off

_

Dehydrated Alcohol (E-02)

Ethanol, anhydrous (1318)

Ph. Eur.

Correction of the sign-off cover sheet Revision 2 Correction 2

E02_Rev2_Corr2
_Corr_cover_sheet
_2021_10_
Sign-off

_

Benzyl Alcohol (E-03)

Benzyl alcohol (0256)

Ph. Eur.

Revision 2 Correction 2

E03_Rev2_
Corr2_2020_
12_Sign-off

_

Calcium Disodium Edetate (E-04)

Sodium calcium edetate (0231)

JP

Correction of the sign-off cover sheet

E-04_Corr_cover_sheet_2023_01_Sign-off

Revision 1 ongoing (stage 2)

Calcium Phosphate Dibasic (E-05)

Calcium hydrogen phosphate dihydrate (0116)

JP

Correction of the sign-off cover sheet Revision 1

E-05_Rev1_Corr_
cover_sheet
_2023_01_Sign-off

_

Calcium Phosphate Dibasic Anhydrous (E-06)

Calcium hydrogen phosphate (0981)

JP

Correction 2 of the sign-off cover sheet Revision 2

E-06_Rev2_Corr2_cover_sheet_2023_01_Sign-off

_

Carmellose Calcium (E-07)

Carmellose calcium (0886)

USP

Correction of the sign-off cover sheet Revision 1 Correction 1

E07_Rev1_Corr1_Corr_cover_sheet_2024_12_Sign-off

_

Carmellose Sodium (E-08)

Carmellose sodium (0472)

USP

-

_

Elaboration ongoing (Stage 2)

Croscarmellose Sodium (E-09)

Croscarmellose sodium (0985)

USP

 Revision 1

E09_Rev1_2020_12_Sign-off

_
Correction of the sign-off cover sheet Revision 1 E-09_Rev1_Corr_cover_sheet_2023_01_Sign-off Revision 2 ongoing (stage 1)

Microcrystalline Cellulose (E-10)

Cellulose, microcrystalline (0316)

USP

Correction 2 of the sign-off cover sheet Revision 3

E-10_Rev3_Corr2_cover_sheet_2023_01_Sign-off

_

Cellulose, Powdered (E-11)

Cellulose, powdered (0315)

USP

Revision 1 Correction 1

E11_Rev1_Corr1_2021_10
_Sign-off

_
Correction of the sign-off cover sheet Revision 1 Correction 1 E-11_Rev1_Corr1_
Corr_cover_sheet_
2023_01_Sign-off		 _

Cellulose Acetate (E-12)

Cellulose acetate (0887)

USP

-

_

Suppressed from the
PDG work
programme in Sept. 2017

Cellulose Acetate Phthalate (E-13)

Cellulose acetate phthalate (0314)

USP

Correction 2 of the sign-off cover sheet Revision 1 Correction 1

E-13_Rev1_Corr1_
Corr2_cover_sheet_
2023_01_Sign-off

_

Citric Acid, Anhydrous (E-14)

Citric acid (0455)

Ph. Eur.

Correction of the sign-off cover sheet Revision 2

E-14_Rev2_Corr_cover_
sheet_
2023_01_Sign-off

_

Citric Acid, Monohydrate (E-15)

Citric acid monohydrate (0456)

Ph. Eur.

Correction of the sign-off cover sheet Revision 2

E-15_Rev2_Corr_cover_sheet_2023_01_Sign-off

_

Crospovidone (E-16)

Crospovidone (0892)

Ph. Eur.

Correction 3 of the sign-off cover sheet

E-16_Corr3_cover_sheet_2023_01_Sign-off

_

Ethylcellulose (E-17)

Ethylcellulose (0822)

Ph. Eur.

Correction of the sign-off cover sheet Revision 2

E-17_Rev2_Corr_
cover_sheet_
2023_01_Sign-off

_

Hydroxyethylcellulose (E-18)

Hydroxyéthylcellulose (0336)

Ph. Eur.

Correction 2 of the sign-off cover sheet

E-18_Corr2_cover_sheet_
2023_01_Sign-off

Revision 1 ongoing
(Stage 2)

Hydroxypropylcellulose (E-19)

Hydroxypropylcellulose (0337)

USP

Correction of the sign-off cover sheet

E-19_Corr3_cover_sheet_
2023_01_Sign-off

_

Hydroxypropylcellulose, Low Substituted (E-20)

Hydroxypropylcellulose faiblement substituée (2083)

USP

Correction 3

E-20_Corr3_2023_01_
Sign-off

_

Hypromellose (E-21)

Hypromellose (0348)

JP

Revision 2 Correction 1

E-21_Rev2_Corr1_
2023-01_Sign-off

_

Hypromellose Phthalate (E-22)

Hypromellose phthalate (0347)

USP

Correction 1

E22_Corr1_
2021_10_Sign-off

_
Correction of the sign-off cover sheet Correction 1 E-22_Corr1_Corr_cover_
sheet_
2023_01_Sign-off		 -

Lactose, Anhydrous (E-23)

Lactose (1061)

Ph. Eur.

Revision 4 Correction 2

E-23_Rev4_Corr2_
2023_01_Sign-off

Revision 5
ongoing (Stage 1)

Lactose, Monohydrate (E-24)

Lactose monohydrate (0187)

USP

Revision 2 Correction 2

E-24_Rev2_Corr2_
2023_01_Sign-off

Revision 3
ongoing (Stage 1)

Magnesium Stearate (E-25)

Magnesium Stearate (E-25)

USP

Correction 2 of the sign-off cover sheet

E-25_Corr2_cover_sheet_
2023_01_Sign-off

_

Methylcellulose (E-26)

Methylcellulose (E-26)

JP

Revision 3 Correction 1

E-26_Rev3_Corr1_
2023_01_Sign-off

_

Methyl Paraben (E-27)

Méthyle (parahydroxybenzoate de) (0409)

JP

Revision 1 Correction 2

E27_Rev1_
Corr2_2020_
12_Sign-off.pdf

_
Correction of the sign-off cover sheet Revision 1 Correction 2 E-27_Rev1_Corr2_Corr_
cover_sheet_
2023_01_Sign-off		  

Petrolatum (E-28)

Paraffin, yellow soft  (1554)

USP

Elaboration

E28_2021_10_
Sign-off

-
Correction of the sign-off cover sheet E-28_Corr_cover_sheet_
2023_01_Sign-off		 -

Petrolatum, White (E-29)

Paraffin, white soft (1799)

USP

Elaboration

E29_2021_10_
Sign-off

-
Correction of the sign-off cover sheet E-29_Corr_cover_sheet_
2023_01_Sign-off		 -

Polyethylene Glycol (E-30)

Macrogols (1444)

USP

_

_

Elaboration ongoing (Stage 1)

Polysorbate 80 (E-31)

Polysorbate 80 (0428)

Ph. Eur.

Correction 3 of the sign-off cover sheet Correction 2 

E-31_Corr3_cover_sheet_
2023_01_Sign-off

Revision 1 ongoing
(Stage 1)

Povidone (E-32)

Povidone (0685)

JP

Correction of the sign-off cover sheet Revision 1 Correction 1

E-32_Rev1_Corr1_Corr_
cover_sheet_2023_01_
Sign-off

Revision 2 ongoing (Stage 1)

Saccharin (E-33)

Saccharin (0947)

USP

_

_

Suppressed from the
PDG work programme
in Sept. 2017

Saccharin, Sodium (E-34)

Saccharin sodium (0787)

USP

_

_

Suppressed from the
PDG work programme
in Sept. 2017

Saccharin, Calcium (E-35)

Saccharin calcium (--)

USP

_

_

Suppressed from the
PDG work programme
in Sept. 2017

Silicon Dioxide (E-36)

Silica, colloidal hydrated (0738)

JP

_

_

Elaboration ongoing (Stage 2)

Silicon Dioxide, Colloidal (E-37)

Silica, colloidal anhydrous (0434)

JP

_

_

Elaboration ongoing (Stage 2)

Sodium Chloride (E-38)

Sodium chloride (0193)

Ph. Eur.

Revision 3 Correction 2

E38_Rev3_Corr2_
2020_12_
Sign-off

_
Correction of the sign-off cover sheet Revision 3 Correction 2 E-38_Rev3_Corr2_Corr_
cover_sheet_2023_
01_Sign-off		 _

Sodium Starch Glycolate (E-39)

Sodium Starch Glycolate (type A)(0983)
Sodium Starch Glycolate (type B)(0984)

USP

Correction 2 of the sign-off cover sheet Revision 3

E-39_Rev3_Corr2_cover_
sheet_2023_01_Sign-off

_

Starch, Corn (E-40)

Maize starch (0344)

USP

Revision 4

E40_Rev4_2024_06_
Sign-off

_

Starch, Potato (E-41)

Potato starch (0355)

Ph. Eur.

Revision 2

E41_Rev2_2011
_06_Sign-off

_

Starch, Rice (E-42)

Rice starch (0349)

Ph. Eur.

Revision 1

E42_Rev1_2013
_11_Sign-off

_

Starch, Wheat (E-43)

Wheat starch (0359)

Ph. Eur.

Correction of the sign-off cover sheet Revision 3 Correction 1

E43_Rev3_Corr1
_Corr_cover_sheet_
2021_10_
Sign-off

_

Stearic Acid (E-44)

Stearic acid (1474)

Ph. Eur.

Revision 2

E44_Rev2_
2021_10_
Sign-off

_
Correction of the sign-off cover sheet Revision 2 E-44_Rev2_Corr_
cover_sheet_2023_01_
Sign-off		 _

Sucrose (E-45)

Sucrose (0204)

Ph. Eur.

Correction of the sign-off cover sheet

E45_Rev cover
sheet_2013_
06_Sign-off

Revision 1 ongoing (Stage 3)

Talc (E-46)

Talc (0438)

Ph. Eur.

Revision 1

E46_Rev1_2008_
06_Sign-off

_

Ethyl Paraben (E-48)

Ethyl parahydroxybenzoate (0900)

JP

Revision 1 Correction 2

E48_Rev1_
Corr2_2020_
12_Sign-off

_
Correction of the sign-off cover sheet Revision 1 Correction 2 E-48_Rev1_Corr2_
Corr_cover_sheet_
2023_01_Sign-off		 _

Propyl Paraben (E-49)

Propyl parahydroxybenzoate (0431)

JP

Revision 1 Correction 2

E49_Rev1_
Corr2_2020_
12_Sign-off

_
Correction of the sign-off cover sheet  Revision 1 Correction 2 E-49_Rev1_Corr2_
Corr_cover_sheet_
2023_01_Sign-off		  

Butyl Paraben (E-50)

Butyl parahydroxybenzoate (0881)

Ph. Eur.

Revision 1 Correction 1

E50_Rev1_
Corr1_2020_
12_Sign-off

_
Correction of the sign-off cover sheet  Revision 1 Correction 1 E-50_Rev1_Corr1_
Corr_cover_sheet_
2023_01_Sign-off		 _

Glycerin (E-51)

Glycerol (0496)/Glycerol (85 per cent) (0497)

USP

-

_

Elaboration
on-going (Stage 1)

Carmellose (E-52)

Carmellose (2360)

JP

Correction of the sign-off cover sheet Revision 1

E-52_Rev1_Corr_cover_
sheet_2023_01_Sign-off

_

Calcium Carbonate (E-53)

Calcium carbonate (0014)

JP

_

_

Suppressed from the
PDG work programme
in Sept. 2017

Copovidone (E-54)

Copovidone (0891)

JP

Correction of the sign-off cover sheet Correction 1

E-54_Corr1_Corr_
cover_sheet_
2023_01_Sign-off

Revision 1 ongoing (Stage 1)

Gelatin (E-55)

Gelatin (0330)

Ph. Eur.

Correction 2 of the sign-off cover sheet Revision 3

E-55_Rev3_Corr2_
cover_sheet_2023_01_Sign-off

_

Glucose Monohydrate/Anhydrous (E-56)

Glucose monohydrate (0178)/Glucose (0177)

Ph. Eur.

Correction 2 of the
sign-off cover sheet

E-56_Corr2_cover_
sheet_2023_01_Sign-off

Mannitol (E-58)

Mannitol (0559)

Ph. Eur.

Correction 3 of the sign-off cover sheet Correction 1

E-58_Corr3_cover_
sheet_2023_01_Sign-off

_

Propylene Glycol (E-59)

Propylene glycol (0430)

Ph. Eur.

-

_

Elaboration ongoing (Stage 2)

Sodium laurylsulfate (E-60)

Sodium lauriIsulfate (0098)

USP

Revision 1

E60_SLS_2019
-10_Rev1_
Sign-off

_

Starch, Pregelatinized (E-61)

Starch, pregelatinised (1267)

JP

-

_

Elaboration ongoing (Stage 1)

Sterile Water For Injections in Containers (E-62)

Water for injections (0169)

USP

-

_

Elaboration ongoing (Stage 1)

Lactose for Inhalation (E-63)

Lactose for Inhalation (--)

USP

_

_

Suppressed from the PDG
work programme in
October 2018

Isomalt (E-64)

Isomalt (1531)

Ph. Eur.

Correction 2 sign-off cover sheet Correction 1

E-64_Corr1_Corr2_
cover_sheet_2023_
01_Sign-off

_

Isostearyl Alcohol (E-65)

Isostearyl alcohol (3016)

JP

-

_

Elaboration ongoing (Stage 1)

Myristyl Myristate (E-66)

Myristyl myristate (3017)

JP

-

_

Elaboration ongoing (Stage 1)

Sodium Cetyl Sulfate (E-67)

Sodium cetyl sulfate (3019)

JP

-

_

Suppressed from the
PDG work
programme in October 2018

Polysorbate 65 (E-68)

Polysorbate 65 (3018)

JP

-

_

Elaboration ongoing (Stage 1)

Calcium Silicate (E-69)

Calcium Silicate (3020)

USP

Elaboration

_

Elaboration ongoing (Stage 1)
Polysorbate 20 (E-70) Polysorbate 20 (0426) USP _ _ Elaboration ongoing (Stage 1)
Purified Water (E-71) Water, purified (0008) USP _ _ Elaboration ongoing (Stage 1)

 

Abbreviations

CP: co-ordinating pharmacopoeia

JP: Japanese Pharmacopoeia

Ph. Eur.: European Pharmacopoeia

USP: United States Pharmacopeia

 

Old procedure (until March 30, 2018)

Current procedure

Stage 1: Identification

Stage 1: Preparation of first draft

Stage 2: Investigation

Stage 3: Proposal for Expert Committee Review

Stage 4: Official Inquiry

Stage 2: Official Inquiry

Stage 5: Consensus

Stage 3: Consensus

Stage 6: Regional Adoption and Implementation

Stage 4: Regional Adoption and Implementation

Stage 7: Inter-Regional Acceptance

Stage 5: Inter-Regional Acceptance (for texts previously evaluated by ICH Q4B for regulatory Interchangeability)