Harmonisation status for Excipient monographs (PDG)
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 August 2024) |
||||||
PDG Monograph name |
Ph. Eur. Monograph |
Co-ordinating pharmacopoeia |
Latest harmonised version |
Sign-off |
Ongoing work |
|
Alcohol (E-01) |
Ethanol (96 per cent) (1317) |
Ph. Eur. |
Correction of the sign-off cover sheet Revision 2 Correction 2 |
_ |
||
Dehydrated Alcohol (E-02) |
Ethanol, anhydrous (1318) |
Ph. Eur. |
Correction of the sign-off cover sheet Revision 2 Correction 2 |
_ |
||
Benzyl Alcohol (E-03) |
Benzyl alcohol (0256) |
Ph. Eur. |
Revision 2 Correction 2 |
|||
_ |
||||||
Calcium Disodium Edetate (E-04) |
Sodium calcium edetate (0231) |
JP |
Correction of the sign-off cover sheet |
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 |
_ |
||
Calcium Phosphate Dibasic Anhydrous (E-06) |
Calcium hydrogen phosphate (0981) |
JP |
Correction 2 of the sign-off cover sheet Revision 2 |
_ |
||
Carmellose Calcium (E-07) |
Carmellose calcium (0886) |
USP |
Revision 1 Correction 1 |
_ |
||
Carmellose Sodium (E-08) |
Carmellose sodium (0472) |
USP |
- |
_ |
Elaboration ongoing (Stage 2) |
|
Croscarmellose Sodium (E-09) |
Croscarmellose sodium (0985) |
USP |
Revision 1 |
_ |
||
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 |
_ |
||
Cellulose, Powdered (E-11) |
Cellulose, powdered (0315) |
USP |
Revision 1 Correction 1 |
_ |
||
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 |
|
Cellulose Acetate Phthalate (E-13) |
Cellulose acetate phthalate (0314) |
USP |
||||
Correction 2 of the sign-off cover sheet Revision 1 Correction 1 |
_ |
|||||
Citric Acid, Anhydrous (E-14) |
Citric acid (0455) |
Ph. Eur. |
Correction of the sign-off cover sheet Revision 2 |
_ |
||
Citric Acid, Monohydrate (E-15) |
Citric acid monohydrate (0456) |
Ph. Eur. |
Correction of the sign-off cover sheet Revision 2 |
_ |
||
Crospovidone (E-16) |
Crospovidone (0892) |
Ph. Eur. |
Correction 3 of the sign-off cover sheet |
_ |
||
Ethylcellulose (E-17) |
Ethylcellulose (0822) |
Ph. Eur. |
Correction of the sign-off cover sheet Revision 2 |
_ |
||
Hydroxyethylcellulose (E-18) |
|
Ph. Eur. |
Correction 2 of the sign-off cover sheet |
Revision 1 ongoing |
||
Hydroxypropylcellulose (E-19) |
Hydroxypropylcellulose (0337) |
USP |
Correction of the sign-off cover sheet |
_ |
||
Hydroxypropylcellulose, Low Substituted (E-20) |
Hydroxypropylcellulose faiblement substituée (2083) |
USP |
Correction 3 |
_ |
||
Hypromellose (E-21) |
Hypromellose (0348) |
JP |
Revision 2 Correction 1 |
_ |
||
Hypromellose Phthalate (E-22) |
Hypromellose phthalate (0347) |
USP |
Correction 1 |
_ |
||
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 |
Revision 5 |
||
Lactose, Monohydrate (E-24) |
Lactose monohydrate (0187) |
USP |
Revision 2 Correction 2 |
Revision 3 |
||
Magnesium Stearate (E-25) |
|
USP |
Correction 2 of the sign-off cover sheet |
_ |
||
Methylcellulose (E-26) |
Methylcellulose (E-26) |
JP |
Revision 3 Correction 1 |
_ |
||
Methyl Paraben (E-27) |
Méthyle (parahydroxybenzoate de) (0409) |
JP |
||||
Revision 1 Correction 2 |
_ |
|||||
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 |
- |
||
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 |
- |
||
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 |
Revision 1 ongoing |
||
Povidone (E-32) |
Povidone (0685) |
JP |
Correction of the sign-off cover sheet Revision 1 Correction 1 |
Revision 2 ongoing (Stage 1) |
||
Saccharin (E-33) |
Saccharin (0947) |
USP |
_ |
_ |
Suppressed from the |
|
Saccharin, Sodium (E-34) |
Saccharin sodium (0787) |
USP |
_ |
_ |
Suppressed from the |
|
Saccharin, Calcium (E-35) |
Saccharin calcium (--) |
USP |
_ |
_ |
Suppressed from the |
|
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 |
_ |
||
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) |
USP |
Correction 2 of the sign-off cover sheet Revision 3 |
_ |
||
Starch, Corn (E-40) |
Maize starch (0344) |
USP |
Revision 4 |
_ |
||
Starch, Potato (E-41) |
Potato starch (0355) |
Ph. Eur. |
Revision 2 |
_ |
||
Starch, Rice (E-42) |
Rice starch (0349) |
Ph. Eur. |
Revision 1 |
_ |
||
Starch, Wheat (E-43) |
Wheat starch (0359) |
Ph. Eur. |
Correction of the sign-off cover sheet Revision 3 Correction 1 |
_ |
||
Stearic Acid (E-44) |
Stearic acid (1474) |
Ph. Eur. |
Revision 2 |
_ |
||
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 |
Revision 1 ongoing (Stage 3) |
||
Talc (E-46) |
Talc (0438) |
Ph. Eur. |
Revision 1 |
_ |
||
Ethyl Paraben (E-48) |
Ethyl parahydroxybenzoate (0900) |
JP |
Revision 1 Correction 2 |
_ |
||
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 |
_ |
||
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 |
_ |
||
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 |
|
Carmellose (E-52) |
Carmellose (2360) |
JP |
Correction of the sign-off cover sheet Revision 1 |
_ |
||
Calcium Carbonate (E-53) |
Calcium carbonate (0014) |
JP |
_ |
_ |
Suppressed from the |
|
Copovidone (E-54) |
Copovidone (0891) |
JP |
Correction of the sign-off cover sheet Correction 1 |
Revision 1 ongoing (Stage 1) |
||
Gelatin (E-55) |
Gelatin (0330) |
Ph. Eur. |
Correction 2 of the sign-off cover sheet Revision 3 |
_ |
||
Glucose Monohydrate/Anhydrous (E-56) |
Glucose monohydrate (0178)/Glucose (0177) |
Ph. Eur. |
Correction 2 of the |
|||
Mannitol (E-58) |
Mannitol (0559) |
Ph. Eur. |
Correction 3 of the sign-off cover sheet Correction 1 |
_ |
||
Propylene Glycol (E-59) |
Propylene glycol (0430) |
Ph. Eur. |
- |
_ |
Elaboration ongoing (Stage 2) |
|
Sodium laurylsulfate (E-60) |
Sodium lauriIsulfate (0098) |
USP |
Revision 1 |
_ |
||
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 |
|
Isomalt (E-64) |
Isomalt (1531) |
Ph. Eur. |
Correction 2 sign-off cover sheet Correction 1 |
_ |
||
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 |
|
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) |