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.
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PH. EUR. HARMONISATION STATUS FOR EXCIPIENTS (as of 31 January 2022) |
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|
PDG# |
Ph. Eur. Monograph |
Co-ordinating pharmacopoeia |
Elaboration/ Revision/ Correction |
Sign-off |
Ongoing work |
|
E-01 |
Ethanol (96 per cent) (1317) |
Ph. Eur. |
Correction of the sign-off cover sheet Revision 2 Correction 2 |
_ |
|
|
E-02 |
Ethanol, anhydrous (1318) |
Ph. Eur. |
Correction of the sign-off cover sheet Revision 2 Correction 2 |
_ |
|
|
E-03 |
Benzyl alcohol (0256) |
Ph. Eur. |
Revision 2 Correction 2 |
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|
_ |
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|
E-04 |
Sodium calcium edetate (0231) |
JP |
Elaboration |
Revision 1 ongoing (stage 2) |
|
|
E-05 |
Calcium hydrogen phosphate dihydrate (0116) |
JP |
Revision 1 |
_ |
|
|
E-06 |
Calcium hydrogen phosphate (0981) |
JP |
Correction of the sign-off cover sheet Revision 2 |
_ |
|
|
E-07 |
Carmellose calcium (0886) |
USP |
Revision 1 |
_ |
|
|
E-08 |
Carmellose sodium (0472) |
USP |
Elaboration |
_ |
Elaboration ongoing (Stage 2) |
|
E-09 |
Croscarmellose sodium (0985) |
USP |
Revision 1 |
_ |
|
|
E-10 |
Cellulose, microcrystalline (0316) |
USP |
Correction of the sign-off cover sheet Revision 3 |
_ |
|
|
E-11 |
Cellulose, powdered (0315) |
USP |
Revision 1 Correction 1 |
_ |
|
|
E-12 |
Cellulose acetate (0887) |
USP |
Suppressed from the PDG work programme in Sept. 2017 |
_ |
_ |
|
E-13 |
Cellulose acetate phthalate (0314) |
USP |
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|
Correction of the sign-off cover sheet Revision 1 Correction 1 |
_ |
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|
E-14 |
Citric acid (0455) |
Ph. Eur. |
Revision 2 |
_ |
|
|
E-15 |
Citric acid monohydrate (0456) |
Ph. Eur. |
Revision 2 |
_ |
|
|
E-16 |
Crospovidone (0892) |
Ph. Eur. |
Correction of the sign-off cover sheet |
_ |
|
|
E-17 |
Ethylcellulose (0822) |
Ph. Eur. |
Revision 2 |
_ |
|
|
E-18 |
Hydroxyethylcellulose (0336) |
Ph. Eur. |
Correction of the sign-off cover sheet |
_ |
|
|
E-19 |
Hydroxypropylcellulose (0337) |
USP |
Correction of the sign-off cover sheet |
_ |
|
|
E-20 |
Hydroxypropylcellulose, low-substituted (2083) |
USP |
Correction of the sign-off cover sheet Correction 2 |
_ |
|
|
E-21 |
Hypromellose (0348) |
JP |
Correction of the sign-off cover sheet Revision 2 |
_ |
|
|
E-22 |
Hypromellose phthalate (0347) |
USP |
Correction 1 |
_ |
|
|
E-23 |
Lactose (1061) |
Ph. Eur. |
Revision 4 Correction 1 |
Revision 5 |
|
|
E-24 |
Lactose monohydrate (0187) |
USP |
Revision 2 Correction 1 |
Revision 3 |
|
|
E-25 |
Magnesium stearate (0229) |
USP |
Correction of the sign-off cover sheet |
_ |
|
|
E-26 |
Methylcellulose (0345) |
JP |
Correction of the sign-off cover sheet Revision 3 |
_ |
|
|
E-27 |
Methyl parahydroxybenzoate (0409) |
JP |
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|
Revision 1 Correction 2 |
_ |
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|
E-28 |
Paraffin, yellow soft (1554) |
USP |
Elaboration |
- |
|
|
E-29 |
Paraffin, white soft (1799) |
USP |
Elaboration |
- |
|
|
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 |
_ |
|
|
E-32 |
Povidone (0685) |
JP |
Revision 1 Correction 1 |
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 |
_ |
|
|
E-39 |
Sodium Starch Glycolate (type A)(0983) |
USP |
Correction of the sign-off cover sheet Revision 3 |
_ |
|
|
E-40 |
Maize starch (0344) |
USP |
Revision 3 |
_ |
|
|
E-41 |
Potato starch (0355) |
Ph. Eur. |
Revision 2 |
_ |
|
|
E-42 |
Rice starch (0349) |
Ph. Eur. |
Revision 1 |
_ |
|
|
E-43 |
Wheat starch (0359) |
Ph. Eur. |
Correction of the sign-off cover sheet Revision 3 Correction 1 |
_ |
|
|
E-44 |
Stearic acid (1474) |
Ph. Eur. |
Revision 2 |
_ |
|
|
E-45 |
Sucrose (0204) |
Ph. Eur. |
Correction of the sign-off cover sheet |
Revision 1 ongoing (Stage 2) |
|
|
E-46 |
Talc (0438) |
Ph. Eur. |
Revision 1 |
_ |
|
|
E-48 |
Ethyl parahydroxybenzoate (0900) |
JP |
Revision 1 Correction 2 |
_ |
|
|
E-49 |
Propyl parahydroxybenzoate (0431) |
JP |
Revision 1 Correction 2 |
_ |
|
|
E-50 |
Butyl parahydroxybenzoate (0881) |
Ph. Eur. |
Revision 1 Correction 1 |
_ |
|
|
E-51 |
Glycerol (0496)/Glycerol (85 per cent) (0497) |
USP |
Elaboration |
_ |
Elaboration |
|
E-52 |
Carmellose (2360) |
JP |
Revision 1 |
_ |
|
|
E-53 |
Calcium carbonate (0014) |
JP |
Suppressed from the PDG work programme in Sept. 2017 |
_ |
_ |
|
E-54 |
Copovidone (0891) |
JP |
Correction 1 |
Revision 1 ongoing (Stage 1) |
|
|
E-55 |
Gelatin (0330) |
Ph. Eur. |
Correction of the sign-off cover sheet Revision 3 |
_ |
|
|
E-56 |
Glucose monohydrate (0178)/Glucose (0177) |
Ph. Eur. |
Elaboration |
_ |
|
|
Revision of the sign-off cover sheet |
_ |
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|
E-58 |
Mannitol (0559) |
Ph. Eur. |
Correction of the sign-off cover sheet Correction 1 |
_ |
|
|
E-59 |
Propylene glycol (0430) |
Ph. Eur. |
Elaboration |
_ |
Elaboration ongoing (Stage 2) |
|
E-60 |
Sodium lauriIsulfate (0098) |
USP |
Revision 1 |
_ |
|
|
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 |
_ |
|
|
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
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Old procedure (until March 30, 2018) |
Current procedure |
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Stage 1: Identification |
Stage 1: Preparation of first draft |
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Stage 2: Investigation |
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Stage 3: Proposal for Expert Committee Review |
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Stage 4: Official Inquiry |
Stage 2: Official Inquiry |
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Stage 5: Consensus |
Stage 3: Consensus |
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Stage 6: Regional Adoption and Implementation |
Stage 4: Regional Adoption and Implementation |
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Stage 7: Inter-Regional Acceptance |
Stage 5: Inter-Regional Acceptance (for texts previously evaluated by ICH Q4B for regulatory Interchangeability) |