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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EP HARMONISATION STATUS FOR EXCIPIENTS (as of 30 November 2019) |
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|
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 |
_ |
|
|
E-02 |
Ethanol, anhydrous (1318) |
Ph. Eur. |
Revision 2 |
_ |
|
|
E-03 |
Benzyl alcohol (0256) |
Ph. Eur. |
Revision 2 |
_ |
|
|
Revision 2 Correction 1 |
_ |
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|
E-04 |
Disodium edetate (0232) |
JP |
Elaboration |
Revision 1 on-going (stage 2) |
|
|
E-05 |
Calcium hydrogen phosphate dihydrate (0116) |
JP |
Revision 1 |
_ |
|
|
E-06 |
Calcium hydrogen phosphate (0981) |
JP |
Revision 2 |
_ |
|
|
E-07 |
Carmellose calcium (0886) |
USP |
Revision 1 |
_ |
|
|
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 |
Revision 1 on-going (stage 2) |
|
|
E-10 |
Cellulose, microcrystalline (0316) |
USP |
Revision 3 |
_ |
|
|
E-11 |
Cellulose, powdered (0315) |
USP |
Revision of the sign-off cover sheet |
_ |
|
|
E-12 |
Cellulose acetate (0887) |
USP |
Suppressed from the PDG work programme in Sept. 2017 |
_ |
_ |
|
E-13 |
Cellulose acetate phthalate (0314) |
USP |
Revision 1 |
_ |
|
|
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. |
Revision of the sign-off cover sheet |
_ |
|
|
E-17 |
Ethylcellulose (0822) |
Ph. Eur. |
Revision 2 |
_ |
|
|
E-18 |
Hydroxyethylcellulose (0336) |
Ph. Eur. |
Elaboration |
_ |
|
|
E-19 |
Hydroxypropylcellulose (0337) |
USP |
Revision of the sign-off cover sheet |
_ |
|
|
E-20 |
Hydroxypropylcellulose, low-substituted (2083) |
USP |
Correction 2 |
_ |
|
|
E-21 |
Hypromellose (0348) |
JP |
Revision 2 |
_ |
|
|
E-22 |
Hypromellose phthalate (0347) |
USP |
Elaboration |
_ |
|
|
E-23 |
Lactose (1061) |
Ph. Eur. |
Revision 4 Correction 1 |
_ |
|
|
E-24 |
Lactose monohydrate (0187) |
USP |
Revision 2 Correction 1 |
_ |
|
|
E-25 |
Magnesium stearate (0229) |
USP |
Elaboration |
_ |
|
|
Correction 1 |
_ |
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|
Correction 2 |
_ |
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|
Correction 3 |
_ |
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|
E-26 |
Methylcellulose (0345) |
JP |
Revision 3 |
_ |
|
|
E-27 |
Methyl parahydroxybenzoate (0409) |
JP |
Revision 1 |
_ |
|
|
Revision 1 Correction 1 |
_ |
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|
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 |
_ |
|
|
E-32 |
Povidone (0685) |
JP |
Revision 1 Correction 1 |
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 |
_ |
|
|
Revision 3 Correction 1 |
_ |
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|
E-39 |
Sodium Starch Glycolate (type A)(0983)/Sodium Starch Glycolate (type B)(0984)/Sodium Starch Glycolate (type C)(1566) |
USP |
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. |
Revision 3 |
_ |
|
|
E-44 |
Stearic acid (1474) |
Ph. Eur. |
Revision of the sign-off cover sheet Revision 1 Correction 1 |
Revision 2 on-going (Stage 1) |
|
|
E-45 |
Sucrose (0204) |
Ph. Eur. |
Revision of the sign-off cover sheet |
Revision 1 on-going (Stage 1) |
|
|
E-46 |
Talc (0438) |
Ph. Eur. |
Revision 1 |
_ |
|
|
E-48 |
Ethyl parahydroxybenzoate (0900) |
JP |
Revision 1 |
_ |
|
|
Revision 1 Correction 1 |
_ |
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|
E-49 |
Propyl parahydroxybenzoate (0431) |
JP |
Revision 1 |
_ |
|
|
Revision 1 Correction 1 |
_ |
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|
E-50 |
Butyl parahydroxybenzoate (0881) |
Ph. Eur. |
Revision 1 |
_ |
|
|
E-51 |
Glycerol (0496)/Glycero (85 per cent)(0497) |
USP |
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 on-going (Stage 1) |
|
|
E-55 |
Gelatin (0330) |
Ph. Eur. |
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 sign-off cover sheet |
_ |
|
|
E-59 |
Propylene glycol (0430) |
Ph. Eur. |
Elaboration |
_ |
Elaboration on-going (Stage 2) |
|
E-60 |
Sodium lauriIlsulfate (0098) |
USP |
Revision 1 |
_ |
|
|
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 |
_ |
|
|
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 |
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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 |
|
Stage 7: Inter-Regional Acceptance |
Stage 5: Inter-Regional Acceptance (for texts previously evaluated by ICH Q4B for regulatory Interchangeability) |