The following table summarises the sign-off coversheets for all monographs of excipients under the Pharmacopoeial Discussion Group (PDG) work plan. These 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 31 January 2022)

PDG#

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

Co-ordinating pharmacopoeia

Elaboration/

Revision/

Correction

Sign-off
document

Ongoing work

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

_

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

_

E-03

Benzyl alcohol (0256)

Ph. Eur.

Revision 2 Correction 2

E03_Rev1_
Corr2_2020_
12_Sign-off

_

E-04

Sodium calcium edetate (0231)

JP

Elaboration

E04_2005_11_Sign-off

Revision 1 ongoing (stage 2)

E-05

Calcium hydrogen phosphate dihydrate (0116)

JP

Revision 1

E05 2011-06-15 Sign_off

_

E-06

Calcium hydrogen phosphate (0981)

JP

Correction of the sign-off cover sheet Revision 2

E06_Rev2_Corr_cover_sheet_2021_10_Sign-off

_

E-07

Carmellose calcium (0886)

USP

Revision 1

E07_Rev1_2003_07_Sign-off

_

E-08

Carmellose sodium (0472)

USP

Elaboration

_

Elaboration ongoing (Stage 2)

E-09

Croscarmellose sodium (0985)

USP

Revision 1

E09_rev1_2020_12_Sign-off

_

E-10

Cellulose, microcrystalline (0316)

USP

Correction of the sign-off cover sheet Revision 3

E10_Rev3_Corr_cover_sheet_2021_10_Sign-off

_

E-11

Cellulose, powdered (0315)

USP

Revision 1 Correction 1

E11_Rev1_Corr1_2021_10
_Sign-off

_

E-12

Cellulose acetate (0887)

USP

Suppressed from the PDG work programme in Sept. 2017

_

_

E-13

Cellulose acetate phthalate (0314)

USP

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

E13_Rev1_Corr1_
Corr_cover
_sheet_2021_10_
Sign-off

_

E-14

Citric acid (0455)

Ph. Eur.

Revision 2

E14_Rev2_2010_06_
Sign-off

_

E-15

Citric acid monohydrate (0456)

Ph. Eur.

Revision 2

E15_Rev2_2010_06_Sign-off

_

E-16

Crospovidone (0892)

Ph. Eur.

Correction of the sign-off cover sheet

E16_Corr_cover_sheet_2021_10_Sign-off

_

E-17

Ethylcellulose (0822)

Ph. Eur.

Revision 2

E17_Rev2_2016_05_
Sign-off

_

E-18

Hydroxyethylcellulose (0336)

Ph. Eur.

Correction of the sign-off cover sheet

E18_Corr_cover
_sheet_2021_10_
Sign-off

_

E-19

Hydroxypropylcellulose (0337)

USP

Correction of the sign-off cover sheet

E19_Corr_cover
_sheet_2021_10_
Sign-off

_

E-20

Hydroxypropylcellulose, low-substituted (2083)

USP

Correction of the sign-off cover sheet Correction 2

E20_Corr2_
Corr_cover_sheet_
2021_10_Sign-off

_

E-21

Hypromellose (0348)

JP

Correction of the sign-off cover sheet Revision 2

E21_Rev2_Corr_cover_
sheet_2021_10_
Sign-off

_

E-22

Hypromellose phthalate (0347)

USP

Correction 1

E22_Corr1_
2021_10_Sign-off

_

E-23

Lactose (1061)

Ph. Eur.

Revision 4 Correction 1   

E23_Rev4_Corr1
_2019-10_
Sign-off

Revision 5
ongoing (Stage 1)

E-24

Lactose monohydrate (0187)

USP

Revision 2 Correction 1   

E24_Rev2_
Corr1_2019-10_
Sign-off

Revision 3
ongoing (Stage 1)

E-25

Magnesium stearate (0229)

USP

Correction of the sign-off cover sheet

E25_Corr_cover sheet_
2020_12_
Sign-off

_

E-26

Methylcellulose (0345)

JP

Correction of the sign-off cover sheet Revision 3

E26_Rev3_
Corr_cover_sheet_
2021_10_Sign-off

_

E-27

Methyl parahydroxybenzoate (0409)

JP

Revision 1 Correction 2

E27_Rev1_
Corr2_2020_
12_Sign-off.pdf

_

E-28

Paraffin, yellow soft  (1554)

USP

Elaboration

E28_2021_10_
Sign-off

-

E-29

Paraffin, white soft (1799)

USP

Elaboration

E29_2021_10_
Sign-off

-

E-30

Macrogols (1444)

USP

Elaboration

_

Elaboration ongoing (Stage 1)

E-31

Polysorbate 80 (0428)

Ph. Eur.

Correction 2 of the sign-off cover sheet Correction 2

E31_Corr2_
cover sheet_
2020_12_
Sign-off

_

E-32

Povidone (0685)

JP

Revision 1 Correction 1   

E32_Rev1 corr1_
2015_11_
Sign-off

Revision 2 ongoing (Stage 1)

E-33

Saccharin (0947)

USP

Suppressed from the PDG work programme in Sept. 2017

_

_

E-34

Saccharin sodium (0787)

USP

Suppressed from the PDG work programme in Sept. 2017

_

_

E-35

Saccharin calcium (--)

USP

Suppressed from the PDG work programme in Sept. 2017

_

_

E-36

Silica, colloidal hydrated (0738)

JP

Elaboration

_

Elaboration ongoing (Stage 2)

E-37

Silica, colloidal anhydrous (0434)

JP

Elaboration

_

Elaboration ongoing (Stage 2)

E-38

Sodium chloride (0193)

Ph. Eur.

Revision 3 Correction 2

E38_Rev3_Corr2_
2020_12_
Sign-off

_

E-39

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

USP

Correction of the sign-off cover sheet Revision 3

E39_Rev3_
Corr_cover_sheet_
2021_10_
Sign-off

_

E-40

Maize starch (0344)

USP

Revision 3

E40_Rev3_2012
_06_Sign-off

_

E-41

Potato starch (0355)

Ph. Eur.

Revision 2

E41_Rev2_2011
_06_Sign-off

_

E-42

Rice starch (0349)

Ph. Eur.

Revision 1

E42_Rev1_2013
_11_Sign-off

_

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

_

E-44

Stearic acid (1474)

Ph. Eur.

Revision 2

E44_Rev2_
2021_10_
Sign-off

_

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 2)

E-46

Talc (0438)

Ph. Eur.

Revision 1

E46_Rev1_2008_
06_Sign-off

_

E-48

Ethyl parahydroxybenzoate (0900)

JP

Revision 1 Correction 2

E48_Rev1_
Corr2_2020_
12_Sign-off

_

E-49

Propyl parahydroxybenzoate (0431)

JP

Revision 1 Correction 2

E49_Rev1_
Corr2_2020_
12_Sign-off

_

E-50

Butyl parahydroxybenzoate (0881)

Ph. Eur.

Revision 1 Correction 1

E50_Rev1_
Corr1_2020_
12_Sign-off

_

E-51

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

USP

Elaboration

_

Elaboration
on-going (Stage 1)

E-52

Carmellose (2360)

JP

Revision 1

E52_Rev1_
2011_11_
Sign_off

_

E-53

Calcium carbonate (0014)

JP

Suppressed from the PDG work programme in Sept. 2017

_

_

E-54

Copovidone (0891)

JP

Correction 1

E54_2019-10_
Corr1_Sign_off

Revision 1 ongoing (Stage 1)

E-55

Gelatin (0330)

Ph. Eur.

Correction of the sign-off cover sheet Revision 3

E55_Rev3_Corr_
cover_sheet_
2021_10_Sign-off

_

E-56

Glucose monohydrate (0178)/Glucose (0177)

Ph. Eur.

Elaboration

E56_2014_06_
Sign-off

_

Revision of the sign-off cover sheet

E56_Rev1
Cover sheet_
2015_11_
Sign-off

_

E-58

Mannitol (0559)

Ph. Eur.

Correction of the sign-off cover sheet Correction 1

E58_Corr
cover sheet_
2018_10_
Sign-off

_

E-59

Propylene glycol (0430)

Ph. Eur.

Elaboration

_

Elaboration ongoing (Stage 2)

E-60

Sodium lauriIsulfate (0098)

USP

Revision 1

E60_SLS_2019
-10_Rev1_
Sign-off

_

E-61

Starch, pregelatinised (1267)

JP

Elaboration

_

Elaboration ongoing (Stage 1)

E-62

Water for injections (0169)

USP

Elaboration

_

Elaboration ongoing (Stage 1)

E-63

Lactose for Inhalation (--)

USP

Suppressed from the PDG work programme in October 2018

_

_

E-64

Isomalt (1531)

Ph. Eur.

Correction sign-off cover sheet

E64_Corr cover
sheet_2018_10_
Sign-off

_

E-65

Isostearyl alcohol (3016)

JP

Elaboration

_

Elaboration ongoing (Stage 1)

E-66

Myristyl myristate (3017)

JP

Elaboration

_

Elaboration ongoing (Stage 1)

E-67

Sodium cetyl sulfate (3019)

JP

Suppressed from the PDG work programme in October 2018

_

_

E-68

Polysorbate 65 (3018)

JP

Elaboration

_

Elaboration ongoing (Stage 1)

E-69

Calcium Silicate (3020)

USP

Elaboration

_

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)