Retour Pharmeuropa 36.3 just released

EDQM Strasbourg, France 03/07/2024
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Pharmeuropa 36.3 just released

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