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Back Pharmeuropa 36.3 just released

EDQM Strasbourg, France 03/07/2024

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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 36.3 is 30 September 2024.

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 32 drafts published in Pharmeuropa 36.3 are listed here.

	*Drafts published in Pharmeuropa* 36.3 (end of commenting period: 30 September 2024)**	Group
1	2.2.44. Total organic carbon in water for pharmaceutical use Reference number: PA/PH/Exp. WAT/T (24) 10 ANP Text number: 20244 Direct link	WAT
2	2.7.23. Numeration of CD34/CD45+ cells in haematopoietic products Reference number: PA/PH/Exp. CTP/T (23) 6 ANP Text number: 20723 Direct link	CTP
3	2.9.42. Dissolution test for lipophilic solid dosage forms Reference number: PA/PH/Exp. 12/T (23) 19 ANP Text number: 20942 Direct link	12
4	2.9.43. Apparent dissolution Reference number: PA/PH/Exp. 12/T (23) 18 ANP Text number: 20943 Direct link	12
5	3.1.8. Silicone oil used as a lubricant Reference number: PA/PH/Exp. 16/T (24) 4 ANP Text number: 30108 Direct link	16
6	5.2.5. Management of extraneous agents in immunological veterinary medicinal products Reference number: PA/PH/Exp. 15V/T (24) 3 ANP Text number: 50205 Direct link	15V
7	Alteplase concentrated solution Reference number: PA/PH/Exp. 6B/T (23) 4 ANP Text number: 3197 Direct link	6B
8	Alteplase powder for injection Reference number: PA/PH/Exp. 6B/T (23) 3 ANP Text number: 1170 Direct link	6B
9	Atazanavir sulfate capsules Reference number: PA/PH/Exp. 17/T (24) 22 ANP Text number: 3112 Direct link	17
10	Diphtheria vaccine (adsorbed) Reference number: PA/PH/Exp. 15/T (23) 3 ANP Text number: 0443 Direct link	15
11	Dodecyl gallate Reference number: PA/PH/Exp. 10A/T (24) 33 ANP Text number: 2078 Direct link	10A
12	Gabapentin Reference number: PA/PH/Exp. 10C/T (24) 11 ANP Text number: 2173 Direct link	10C
13	Golimumab injection Reference number: PA/PH/Exp. P4Bio/T (21) 17 ANP Text number: 3187 Direct link	P4Bio
14	Human albumin solution Reference number: PA/PH/Exp. 6B/T (24) 4 ANP Text number: 0255 Direct link	6B
15	Ispaghula husk Reference number: PA/PH/Exp. 13B/T (24) 17 ANP Text number: 1334 Direct link	13B
16	Ispaghula seed Reference number: PA/PH/Exp. 13B/T (11) 80 ANP Text number: 1333 Direct link	13B
17	Nettle root Reference number: PA/PH/Exp. 13B/T (21) 43 ANP R1 Text number: 2538 Direct link	13B
18	Nifedipine Reference number: PA/PH/Exp. 10B/T (24) 41 ANP Text number: 0627 Direct link	10B
19	Octyl gallate Reference number: PA/PH/Exp. 10A/T (24) 34 ANP Text number: 2057 Direct link	10A
20	Oxygen Reference number: PA/PH/Exp. 9G/T (24) 3 ANP Text number: 0417 Direct link	9G
21	Oxygen (93 per cent) Reference number: PA/PH/Exp. 9G/T (24) 2 ANP Text number: 2455 Direct link	9G
22	Oxygen (98 per cent) Reference number: PA/PH/Exp. 9G/T (24) 4 ANP Text number: 3098 Direct link	9G
23	Pregabalin Reference number: PA/PH/Exp. 10C/T (24) 10 ANP Text number: 2777 Direct link	10C
24	Psyllium seed Reference number: PA/PH/Exp. 13B/T (24) 18 ANP Text number: 0858 Direct link	13B
25	Ribwort plantain liquid extract Reference number: PA/PH/Exp. 13B/T (22) 62 ANP Text number: 2961 Direct link	13B
26	Sodium hyaluronate Reference number: PA/PH/Exp. 6/T (24) 15 ANP Text number: 1472 Direct link	6
27	Testosterone enantate Reference number: PA/PH/Exp. 10B/T (24) 44 ANP Text number: 1048 Direct link	10B
28	Ustekinumab concentrated solution Reference number: PA/PH/Exp. P4Bio/T (21) 16 ANP Text number: 3165 Direct link	P4Bio
29	Ustekinumab injection Reference number: PA/PH/Exp. P4Bio/T (21) 18 ANP Text number: 3188 Direct link	P4Bio
30	Veterinary semi-solid preparations for oral use Reference number: PA/PH/Exp. 12/T (21) 4 ANP R4 Text number: 2638 Direct link	12
31	Water for injections Reference number: PA/PH/Exp. WAT/T (24) 8 ANP Text number: 0169 Direct link	WAT
32	Water, purified Reference number: PA/PH/Exp. WAT/T (24) 9 ANP Text number: 0008 Direct link	WAT

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