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 37.1 is 31 March 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 40 drafts published in Pharmeuropa 37.1 are listed here.
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Drafts published in Pharmeuropa 37.1 (end of commenting period: 31 March 2025) |
Group |
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1 |
2.1.7. Balances for analytical purposes Reference number: PA/PH/Exp. MG/T (24) 4 ANP Text number: 20107 |
MG |
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2 |
2.5.43. Size exclusion chromatography for recombinant therapeutic monoclonal antibodies Reference number: PA/PH/Exp. MAB/T (23) 4 ANP Text number: 20543 |
MAB |
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3 |
2.5.45. Photoionisation detectors for the detection of hydrocarbons/oils in gases Reference number: PA/PH/Exp. 9G/T (22) 3 ANP Text number: 20545 |
9G |
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4 |
Acetylsalicylic acid Reference number: PA/PH/Exp. 10A/T (24) 68 ANP Text number: 0309 |
10A |
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5 |
Alovudine (18F) injection Reference number: PA/PH/Exp. 14/T (24) 7 ANP Text number: 2460 |
14 |
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6 |
Atropine hemisulfate hemihydrate Reference number: PA/PH/Exp. 11/T (23) 47 ANP R1 Text number: 0068 |
11 |
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7 |
Carbidopa monohydrate Reference number: PA/PH/Exp. 10A/T (23) 81 ANP Text number: 0755 |
10A |
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8 |
Cat’s claw bark Reference number: PA/PH/Exp. 13B/T (10) 3 ANP R1 Text number: 2530 |
13B |
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9 |
Cefixime trihydrate Reference number: PA/PH/Exp. 7/T (13) 138 ANP R1 Text number: 1188 |
7 |
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10 |
Chicory root Reference number: PA/PH/Exp. 13B/T (24) 12 ANP Text number: 2948 |
13B |
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11 |
Cilastatin sodium Reference number: PA/PH/Exp. 10C/T (24) 39 ANP Text number: 1408 |
10C |
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12 |
Doxazosin mesilate Reference number: PA/PH/Exp. 10A/T (24) 69 ANP Text number: 2125 |
10A |
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13 |
Ethacridine lactate monohydrate Reference number: PA/PH/Exp. 10D/T (24) 44 ANP Text number: 1591 |
10D |
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14 |
Fludeoxyglucose (18F) injection Reference number: PA/PH/Exp. 14/T (24) 21 ANP Text number: 1325 |
14 |
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15 |
Fluoride (18F) solution for radiolabelling Reference number: PA/PH/Exp. 14/T (24) 25 ANP Text number: 2390 |
14 |
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16 |
Fluorocholine (18F) injection Reference number: PA/PH/Exp. 14/T (24) 23 ANP Text number: 2793 |
14 |
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17 |
Fluorodopa (18F) (prepared by electrophilic substitution) injection Reference number: PA/PH/Exp. 14/T (24) 24 ANP Text number: 1918 |
14 |
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18 |
Fluorodopa (18F) (prepared by nucleophilic substitution) injection Reference number: PA/PH/Exp. 14/T (24) 28 ANP Text number: 2481 |
14 |
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19 |
Fluoroethyl-l-tyrosine (18F) injection Reference number: PA/PH/Exp. 14/T (24) 27 ANP Text number: 2466 |
14 |
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20 |
Fluoromisonidazole (18F) injection Reference number: PA/PH/Exp. 14/T (24) 26 ANP Text number: 2459 |
14 |
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21 |
Fluticasone propionate Reference number: PA/PH/Exp. 10C/T (24) 37 ANP Text number: 1750 |
10C |
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22 |
Goldenrod Reference number: PA/PH/Exp. 13B/T (24) 67 ANP Text number: 1892 |
13B |
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23 |
Hyoscine hydrobromide hydrate Reference number: PA/PH/Exp. 11/T (24) 105 ANP Text number: 0106 |
11 |
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24 |
Levomenthol Reference number: PA/PH/Exp. 10D/T (24) 60 ANP Text number: 0619 |
10D |
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25 |
Linseed oil, virgin Reference number: PA/PH/Exp. 13H/T (24) 144 ANP Text number: 1908 |
13H |
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26 |
Metoclopramide Reference number: PA/PH/Exp. 10A/T (24) 19 ANP Text number: 1348 |
10A |
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27 |
Metoclopramide hydrochloride monohydrate Reference number: PA/PH/Exp. 10A/T (24) 20 ANP Text number: 0674 |
10A |
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28 |
Mitoxantrone hydrochloride Reference number: PA/PH/Exp. 11/T (24) 99 ANP Text number: 1243 |
11 |
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29 |
Nabilone Reference number: PA/PH/Exp. 11/T (23) 56 ANP Text number: 3102 |
11 |
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30 |
Nettle leaf Reference number: PA/PH/Exp. 13B/T (24) 65 ANP Text number: 1897 |
13B |
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31 |
Nilotinib hydrochloride monohydrate Reference number: PA/PH/Exp. P4/T (22) 27 ANP Text number: 2993 |
P4 |
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32 |
Pentamidine diisetionate Reference number: PA/PH/Exp. 11/T (24) 69 ANP Text number: 1137 |
11 |
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33 |
Peppermint leaf Reference number: PA/PH/Exp. 13A/T (24) 63 ANP Text number: 0406 |
13A |
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34 |
Peppermint leaf dry extract Reference number: PA/PH/Exp. 13A/T (24) 64 ANP Text number: 2382 |
13A |
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35 |
PSMA-1007 (18F) injection Reference number: PA/PH/Exp. 14/T (24) 29 ANP Text number: 3116 |
14 |
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36 |
Salbutamol sulfate Reference number: PA/PH/Exp. 10A/T (24) 72 ANP Text number: 0687 |
10A |
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37 |
Silver sulfate Reference number: PA/PH/Exp. 9/T (18) 7 ANP Text number: 3013 |
9 |
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38 |
Sodium fluoride (18F) injection Reference number: PA/PH/Exp. 14/T (24) 22 ANP Text number: 2100 |
14 |
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39 |
Suppression of Dextromoramide tartrate Reference number: PA/PH/Exp. 11/T (24) 117 ANP Text number: 0021 |
11 |
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40 |
Zirconium (89Zr) oxalate solution for radiolabelling Reference number: PA/PH/Exp. 14/T (21) 25 ANP Text number: 3153 |
14 |