All new European Pharmacopoeia (Ph. Eur.) texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments on Pharmeuropa 37.2 is 30 June 2025.
Users and interested parties are welcome to comment on these drafts.
It should be noted that:
- although draft monographs must not be regarded as official standards, they will, once adopted by the Ph. Eur. Commission at a later date, become applicable and legally binding standards for the products concerned in all Ph. Eur. member states;
- while general texts are not legally binding per se, they become mandatory when referred to in a monograph. Changes to general texts may therefore impact monographs.
It is therefore extremely important that users provide feedback on such drafts.
Comments made after adoption of the text and/or publication in the Ph. Eur. will be too late to be considered. Users may then be in a position where their product is not compliant with the Ph. Eur. monograph, which is a legal standard in Europe. This could ultimately lead to a situation where a product can no longer be marketed in Europe.
So don’t miss this opportunity to provide your comments. The 54 drafts published in Pharmeuropa 37.2 are listed here.
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Drafts published in Pharmeuropa 37.2 (end of commenting period: 30 June 2025) |
Group |
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1 |
2.4-Dichlorobenzyl alcohol Reference number: PA/PH/Exp. 11/T (24) 133 ANP Text number: 2410 |
11 |
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2 |
2.2.22. Atomic emission spectrometry Reference number: PA/PH/Exp. MG/T (24) 11 ANP Text number: 20222 |
ICP |
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3 |
2.2.23. Atomic absorption spectrometry Reference number: PA/PH/Exp. MG/T (24) 12 ANP Text number: 20223 |
ICP |
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4 |
2.2.57. Inductively coupled plasma-atomic emission spectrometry Reference number: PA/PH/Exp. MG/T (24) 5 ANP Text number: 20257 |
MG |
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5 |
2.2.58. Inductively coupled plasma-mass spectrometry Reference number: PA/PH/Exp. MG/T (24) 14 ANP Text number: 20258 |
MG |
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6 |
2.2.62. Evaporative light-scattering detection Reference number: PA/PH/Exp. MG/T (24) 10 ANP Text number: 20262 |
MG |
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7 |
2.6.14. Bacterial endotoxins Reference number: PA/PH/Exp. BET/T (24) 4 ANP Text number: 20614 |
BET |
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8 |
2.7.38. Bacteriophage potency determination Reference number: PA/PH/Exp. BACT/T (24) 1 ANP Text number: 20738 |
BACT |
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9 |
2.9.50. Particle size analysis by dynamic light scattering Reference number: PA/PH/Exp. POW/T (24) 31 ANP Text number: 20950 |
POW |
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10 |
5.1.13. Pyrogenicity Reference number: PA/PH/Exp. BET/T (25) 2 ANP Text number: 50113 |
BET |
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11 |
5.1.6. Alternative methods for control of microbiological quality Reference number: PA/PH/Exp. 1/T (23) 18 ANP Text number: 50106 |
1 |
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12 |
5.44. Characterisation of powder behaviour during compression Reference number: PA/PH/Exp. POW/T (24) 18 ANP Text number: 54400 |
POW |
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13 |
Aluminium phosphate, hydrated, for adsorption Reference number: PA/PH/Exp. 9/T (18) 25 ANP Text number: 3065 |
9 |
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14 |
Cabazitaxel Reference number: PA/PH/Exp. 11/T (24) 127 ANP Text number: 3223 |
11 |
|
15 |
Chlorpromazine hydrochloride Reference number: PA/PH/Exp. 10A/T (25) 7 ANP Text number: 0475 |
10A |
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16 |
Cholesterol for parenteral use Reference number: PA/PH/Exp. VIT/T (22) 29 ANP R1 Text number: 2397 |
VIT |
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17 |
Coffea for homoeopathic preparations Reference number: PA/PH/Exp. HOM/T (21) 32 ANP Text number: 3138 |
HOM |
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18 |
Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and haemophilus type b conjugate vaccine (adsorbed) Reference number: PA/PH/Exp. 15/T (24) 22 ANP Text number: 2067 |
15 |
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19 |
Frangula bark Reference number: PA/PH/Exp. 13B/T (24) 4 ANP Text number: 0025 |
13B |
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20 |
Frangula bark dry extract, standardised Reference number: PA/PH/Exp. 13B/T (24) 5 ANP Text number: 1214 |
13B |
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21 |
Gallium (68Ga) chloride (accelerator-produced) solution for radiolabelling Reference number: PA/PH/Exp. 14/T (24) 15 ANP Text number: 3109 |
14 |
|
22 |
Guar Reference number: PA/PH/Exp. 13B/T (25) 7 ANP Text number: 1218 |
13B |
|
23 |
Histamine dihydrochloride Reference number: PA/PH/Exp. 11/T (21) 27 ANP R2 Text number: 0143 |
11 |
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24 |
Hydroxyethylcellulose Reference number: PA/PH/Exp. CEL/T (25) 2 ANP Text number: 0336 |
CEL |
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25 |
Indigotindisulfonate disodium hydrate Reference number: PA/PH/Exp. 17/T (23) 7 ANP Text number: 3216 |
17 |
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26 |
Indigotindisulfonate disodium injection Reference number: PA/PH/Exp. 17/T (23) 16 ANP Text number: 3226 |
17 |
|
27 |
Isoniazid Reference number: PA/PH/Exp. SIT/T (25) 4 ANP Text number: 0146 |
10A |
|
28 |
Lercanidipine hydrochloride Reference number: PA/PH/Exp. 10B/T (25) 9 ANP Text number: 3052 |
10B |
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29 |
Levothyroxine sodium hydrate Reference number: PA/PH/Exp. 11/T (24) 114 ANP Text number: 0401 |
11 |
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30 |
Linagliptin Reference number: PA/PH/Exp. P4/T (21) 41 ANP R1 Text number: 3173 |
P4 |
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31 |
Manganese gluconate Reference number: PA/PH/Exp. 9/T (25) 2 ANP Text number: 2162 |
9 |
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32 |
Metformin hydrochloride Reference number: PA/PH/Exp. 10A/T (24) 44 ANP Text number: 0931 |
10A |
|
33 |
Metronidazole Reference number: PA/PH/Exp. 10A/T (25) 8 ANP Text number: 0675 |
10A |
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34 |
Mint haplocalyx herb Reference number: PA/PH/Exp. TCM/T (24) 59 ANP Text number: 3191 |
TCM |
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35 |
Nintedanib esilate Reference number: PA/PH/Exp. P4/T (23) 37 ANP Text number: 3237 |
P4 |
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36 |
Penbutolol sulfate Reference number: PA/PH/Exp. 11/T (24) 113 ANP Text number: 1461 |
11 |
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37 |
Sunitinib malate Reference number: PA/PH/Exp. 17/T (24) 40 ANP Text number: 3085 |
17 |
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38 |
Sunitinib malate capsules Reference number: PA/PH/Exp. 17/T (24) 41 ANP Text number: 3086 |
17 |
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39 |
Technetium (99mTc) bicisate injection Reference number: PA/PH/Exp. 14/T (24) 33 ANP Text number: 2123 |
14 |
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40 |
Technetium (99mTc) colloidal rhenium sulfide injection Reference number: PA/PH/Exp. 14/T (18) 44 ANP Text number: 0126 |
14 |
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41 |
Technetium (99mTc) colloidal tin injection Reference number: PA/PH/Exp. 14/T (24) 37 ANP Text number: 0689 |
14 |
|
42 |
Technetium (99mTc) etifenin injection Reference number: PA/PH/Exp. 14/T (18) 45 ANP Text number: 0585 |
14 |
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43 |
Technetium (99mTc) exametazime injection Reference number: PA/PH/Exp. 14/T (24) 34 ANP Text number: 1925 |
- |
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44 |
Technetium (99mTc) gluconate injection Reference number: PA/PH/Exp. 14/T (24) 36 ANP Text number: 1047 |
14 |
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45 |
Technetium (99mTc) mebrofenin injection Reference number: PA/PH/Exp. 14/T (24) 32 ANP Text number: 2393 |
14 |
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46 |
Technetium (99mTc) medronate injection Reference number: PA/PH/Exp. 14/T (24) 39 ANP Text number: 0641 |
14 |
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47 |
Technetium (99mTc) mertiatide injection Reference number: PA/PH/Exp. 14/T (24) 35 ANP Text number: 1372 |
14 |
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48 |
Technetium (99mTc) microspheres injection Reference number: PA/PH/Exp. 14/T (24) 31 ANP Text number: 0570 |
14 |
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49 |
Technetium (99mTc) pentetate injection Reference number: PA/PH/Exp. 14/T (18) 46 ANP Text number: 0642 |
14 |
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50 |
Technetium (99mTc) succimer injection Reference number: PA/PH/Exp. 14/T (24) 38 ANP Text number: 0643 |
14 |
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51 |
Tetanus vaccine (adsorbed) Reference number: PA/PH/Exp. 15/T (24) 26 ANP Text number: 0452 |
15 |
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52 |
Tetanus vaccine for veterinary use Reference number: PA/PH/Exp. 15V/T (24) 17 ANP Text number: 0697 |
15V |
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53 |
Thiamazole Reference number: PA/PH/Exp. SIT/T (25) 3 ANP Text number: 1706 |
10A |
|
54 |
Vancomycin hydrochloride Reference number: PA/PH/Exp. 7/T (23) 30 ANP R1 Text number: 1058 |
7 |