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Harmonisation status for Excipient monographs (PDG)

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.

 

EP HARMONISATION STATUS FOR EXCIPIENTS (as of 30  November 2019)

PDG#

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

Coordinating pharmacopoeia

Elaboration/Revision/Correction

Sign-off document

On-going work

E-01

Ethanol (96 per cent) (1317)

Ph. Eur.

Revision 2

E01_Rev2_2012_11_Sign-off

_

E-02

Ethanol, anhydrous (1318)

Ph. Eur.

Revision 2

E02_Rev2_2012_11_Sign-off

_

E-03

Benzyl alcohol (0256)

Ph. Eur.

Revision 2

E03_Rev2_2008_06_Sign-off

_

Revision 2 Correction 1

E03_Rev2_Corr_2011_06_Sign-off

_

E-04

Disodium edetate (0232)

JP

Elaboration

E04_2005_11_Sign-off

Revision 1 on-going (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

Revision 2

E06_Rev2_2017_09_Sign-off

_

E-07

Carmellose calcium (0886)

USP

Revision 1

E07_Rev1_2003_07_Sign-off

_

E-08

Carmellose sodium (0472)

USP

Elaboration

_

Elaboration on-going (Stage 1)

E-09

Croscarmellose sodium (0985)

USP

Revision of the sign-off cover sheet

E09_Rev cover sheet_2016_05_Sign-off

Revision 1 on-going (stage 2)

E-10

Cellulose, microcrystalline (0316)

USP

Revision 3

E10_Rev3_2018_10_Sign-off

_

E-11

Cellulose, powdered (0315)

USP

Revision of the sign-off cover sheet

E11_Rev cover sheet_2016_05_Sign-off

_

E-12

Cellulose acetate (0887)

USP

Suppressed from the PDG work programme in Sept. 2017

_

_

E-13

Cellulose acetate phthalate (0314)

USP

Revision 1

E13_Rev1_2010_11_Sign-off

_

Revision 1 Correction 1

E13_Rev1_Corr1_2012_06_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.

Revision of the sign-off cover sheet

E16_Correction cover sheet_2018_11_Sign-off

_

E-17

Ethylcellulose (0822)

Ph. Eur.

Revision 2

E17_Rev2_2016_05_Sign-off

_

E-18

Hydroxyethylcellulose (0336)

Ph. Eur.

Elaboration

E18_2016_07_Sign-off

_

E-19

Hydroxypropylcellulose (0337)

USP

Revision of the sign-off cover sheet

E19_Revision Cover sheet_2017_09_Sign-off

_

E-20

Hydroxypropylcellulose, low-substituted (2083)

USP

Correction 2

E20_Corr2_2016_10_Sign-off

_

E-21

Hypromellose (0348)

JP

Revision 2

E21_Rev2_2017_09_Sign-off

_

E-22

Hypromellose phthalate (0347)

USP

Elaboration

E22_2006_06_Sign-off

_

E-23

Lactose (1061)

Ph. Eur.

Revision 4 Correction 1   

E23_Rev4_Corr1_2019-10_Sign-off

_

E-24

Lactose monohydrate (0187)

USP

Revision 2 Correction 1   

E24_Rev2_Corr1_2019-10_Sign-off

_

E-25

Magnesium stearate (0229)

USP

Elaboration

E25_2008_06_Sign-off

_

Correction 1

E25_Corr1_2008-11_sign_off

_

Correction 2

E25_Corr2_2012_06_Sign-off

_

Correction 3

E25_Corr3_2013_06_Sign-off

_

E-26

Methylcellulose (0345)

JP

Revision 3

E26_Rev3_2017_09_Sign-off

_

E-27

Methyl parahydroxybenzoate (0409)

JP

Revision 1

E27_Rev1_2009-06_sign_off

_

Revision 1 Correction 1   

E27_Rev1 corr1_2011_11S_Sign-off

_

E-28

Paraffin, yellow soft  (1554)

USP

Elaboration

_

Elaboration on-going (Stage 2)

E-29

Paraffin, white soft (1799)

USP

Elaboration

_

Elaboration on-going (Stage 2)

E-30

Macrogols (1444)

USP

Elaboration

_

Elaboration on-going (Stage 1)

E-31

Polysorbate 80 (0428)

Ph. Eur.

Revision of the sign-off cover sheet Correction 2

E31_Rev corr2 cover sheet_2016_10_Sign-off

_

E-32

Povidone (0685)

JP

Revision 1 Correction 1   

E32_Rev1 corr1_2015_11_Sign-off

Revision 2 on-going (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 on-going (Stage 2)

E-37

Silica, colloidal hanhydrous (0434)

JP

Elaboration

_

Elaboration on-going (Stage 2)

E-38

Sodium chloride (0193)

Ph. Eur.

Revision 3

E38_Rev3_2013_10_Sign-off

_

Revision 3 Correction 1

E38_Rev3 corr1_2016_07_Sign-off

_

E-39

Sodium Starch Glycolate (type A)(0983)/Sodium Starch Glycolate (type B)(0984)/Sodium Starch Glycolate (type C)(1566)

USP

Revision 3

E39_Rev3_2013_06_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.

Revision 3

E43_Rev3_2018_10-Sign-off

_

E-44

Stearic acid (1474)

Ph. Eur.

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

E44_Rev1_corr1_rev cover sheet_2015_07_Sign-off

Revision 2 on-going (Stage 1)

E-45

Sucrose (0204)

Ph. Eur.

Revision of the sign-off cover sheet

E45_Rev cover sheet_2013_06_Sign-off

Revision 1 on-going (Stage 1)

E-46

Talc (0438)

Ph. Eur.

Revision 1

E46_Rev1_2008_06_Sign-off

_

E-48

Ethyl parahydroxybenzoate (0900)

JP

Revision 1

E48_Rev1_2009-06_sign_off

_

Revision 1 Correction 1

E48_Rev1_Corr1_2011_11_Sign-off

_

E-49

Propyl parahydroxybenzoate (0431)

JP

Revision 1

E49_Rev1_2009-06_sign_off

_

Revision 1 Correction 1

E49_Rev1 Corr1_2011_11_Sign-off

_

E-50

Butyl parahydroxybenzoate (0881)

Ph. Eur.

Revision 1

E50_Rev1_2010_06_Sign-off

_

E-51

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

USP

Elaboration

_

_

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 on-going (Stage 1)

E-55

Gelatin (0330)

Ph. Eur.

Revision 3

E55ab_2019-10_Rev3_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 sign-off cover sheet

E58_Corr cover sheet_2018_10_Sign-off

_

E-59

Propylene glycol (0430)

Ph. Eur.

Elaboration

_

Elaboration on-going (Stage 2)

E-60

Sodium lauriIlsulfate (0098)

USP

Revision 1

E60_SLS_2019-10_Rev1_Sign-off

_

E-61

Starch, pregelatinised (1267)

JP

Elaboration

_

Elaboration on-going (Stage 1)

E-62

Water for injections (0169)

USP

Elaboration

_

Elaboration on-going (Stage 2)

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 on-going (Stage 1)

E-66

Myristyl myristate (3017)

JP

Elaboration

_

Elaboration on-going (Stage 0)

E-67

Sodium cetyl sulfate (3019)

JP

Suppressed from the PDG work programme in October 2018

_

_

E-68

Polysorbate 65 (3018)

JP

Elaboration

_

Elaboration on-going (Stage 0)

E-69

Calcium Silicate (3020)

USP

Elaboration

_

Elaboration on-going (Stage 1)

 

Abbreviations

CP: coordinating 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)

 

 

 

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