null Pharmeuropa 34.1 just released

EDQM Strasbourg, France 05/01/2022
Pharmeuropa 34.1 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 34.1 is 31 March 2022.

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;
  • if 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 48 drafts published in Pharmeuropa 34.1 are listed here.

 

Drafts published in Pharmeuropa 34.1 (end of commenting period: 31 March 2022)

Group

1

2.7.28. Colony-forming cell assay for human haematopoietic progenitor cells

Reference number: PA/PH/Exp. CTP/T (21) 18 ANP

Text number: 20728

Direct link

CTP

2

2.7.29. Nucleated cell count and viability

Reference number: PA/PH/Exp. CTP/T (21) 17 ANP

Text number: 20729

Direct link

CTP

3

3.1.17. Cyclo-olefin copolymers

Reference number: PA/PH/Exp. 16/T (19) 17 ANP R3

Text number: 30117

Direct link

16

4

Agnus castus fruit

Reference number: PA/PH/Exp. 13B/T (21) 34 ANP

Text number: 2147

Direct link

13B

5

Bismuth subcarbonate

Reference number: PA/PH/Exp. 9/T (21) 31 ANP

Text number: 0012

Direct link

9

6

Bismuth subgallate

Reference number: PA/PH/Exp. 9/T (21) 32 ANP

Text number: 1493

Direct link

9

7

Bismuth subnitrate, heavy

Reference number: PA/PH/Exp. 9/T (21) 33 ANP

Text number: 1494

Direct link

9

8

Bismuth subsalicylate

Reference number: PA/PH/Exp. 9/T (21) 34 ANP

Text number: 1495

Direct link

9

9

Black horehound

Reference number: PA/PH/Exp. 13B/T (19) 31 ANP

Text number: 1858

Direct link

13B

10

Bogbean leaf

Reference number: PA/PH/Exp. 13B/T (21) 32 ANP

Text number: 1605

Direct link

13B

11

Burdock root

Reference number: PA/PH/Exp. 13B/T (20) 13 ANP

Text number: 2943

Direct link

13B

12

Caspofungin acetate

Reference number: PA/PH/Exp. 7/T (17) 7 ANP R2

Text number: 3029

Direct link

7

13

Centaury

Reference number: PA/PH/Exp. 13B/T (21) 47 ANP

Text number: 1301

Direct link

13B

14

Donepezil hydrochloride

Reference number: PA/PH/Exp. 10A/T (21) 113 ANP

Text number: 2582

Direct link

10A

15

Eclipta herb with root

Reference number: PA/PH/Exp. 13B/T (15) 19 ANP

Text number: 2852

Direct link

13B

16

Edotreotide acetate for radiopharmaceutical preparations

Reference number: PA/PH/Exp. PRP/T (15) 5 ANP

Text number: 2544

Direct link

PRP

17

Fenbendazole for veterinary use

Reference number: PA/PH/Exp. 10A/T (18) 78 ANP R1

Text number: 1208

Direct link

10A

18

Gallium (68Ga) DOTANOC injection

Reference number: PA/PH/Exp. 14/T (21) 39 ANP

Text number: 3051

Direct link

14

19

Gallium (68Ga) oxodotreotide injection

Reference number: PA/PH/Exp. 14/T (21) 38 ANP

Text number: 3050

Direct link

14

20

Gozetotide for radiopharmaceutical preparations

Reference number: PA/PH/Exp. PRP/T (16) 19 ANP

Text number: 3042

Direct link

PRP

21

Halofantrine hydrochloride

Reference number: PA/PH/Exp. 10B/T (20) 66 ANP R1

Text number: 1979

Direct link

10B

22

Horse-chestnut bark

Reference number: PA/PH/Exp. 13B/T (20) 16 ANP

Text number: 2945

Direct link

13B

23

Immortelle flower

Reference number: PA/PH/Exp. 13B/T (19) 24 ANP

Text number: 3089

Direct link

13B

24

Ispaghula husk

Reference number: PA/PH/Exp. 13B/T (21) 52 ANP

Text number: 1334

Direct link

13B

25

Mepyramine maleate

Reference number: PA/PH/Exp. 10C/T (21) 33 ANP

Text number: 0278

Direct link

10C

26

Mercaptopurine monohydrate

Reference number: PA/PH/Exp. 10B/T (20) 69 ANP R1

Text number: 0096

Direct link

10B

27

Milk thistle fruit

Reference number: PA/PH/Exp. 13B/T (21) 39 ANP

Text number: 1860

Direct link

13B

28

Norgestrel

Reference number: PA/PH/Exp. 10B/T (17) 93 ANP

Text number: 0940

Direct link

10B

29

Oak bark

Reference number: PA/PH/Exp. 13B/T (21) 45 ANP

Text number: 1887

Direct link

13B

30

Oxodotreotide acetate for radiopharmaceutical preparations

Reference number: PA/PH/Exp. PRP/T (20) 19 ANP

Text number: 3157

Direct link

PRP

31

Pelargonium root

Reference number: PA/PH/Exp. 13B/T (21) 41 ANP

Text number: 2264

Direct link

13B

32

Pimozide

Reference number: PA/PH/Exp. 10B/T (21) 83 ANP

Text number: 1254

Direct link

10B

33

Potassium acetate

Reference number: PA/PH/Exp. 9/T (21) 29 ANP

Text number: 1139

Direct link

9

34

Psyllium seed

Reference number: PA/PH/Exp. 13B/T (21) 53 ANP

Text number: 0858

Direct link

13B

35

Rabeprazole sodium

Reference number: PA/PH/Exp. 10C/T (18) 53 ANP R1

Text number: 2868

Direct link

10C

36

Salbutamol

Reference number: PA/PH/Exp. 10A/T (13) 109 ANP R3

Text number: 0529

Direct link

10A

37

Salbutamol sulfate

Reference number: PA/PH/Exp. 10A/T (13) 108 ANP R3

Text number: 0687

Direct link

10A

38

Sotalol hydrochloride

Reference number: PA/PH/Exp. 10A/T (21) 114 ANP

Text number: 2004

Direct link

10A

39

Sulfobutylbetadex sodium

Reference number: PA/PH/Exp. CRB/T (21) 6 ANP

Text number: 2804

Direct link

CRB

40

Tormentil

Reference number: PA/PH/Exp. 13B/T (21) 51 ANP

Text number: 1478

Direct link

13B

41

Valerian dry aqueous extract

Reference number: PA/PH/Exp. 13B/T (21) 57 ANP

Text number: 2400

Direct link

13B

42

Valerian dry hydroalcoholic extract

Reference number: PA/PH/Exp. 13B/T (21) 56 ANP

Text number: 1898

Direct link

13B

43

Valerian root

Reference number: PA/PH/Exp. 13B/T (21) 54 ANP

Text number: 0453

Direct link

13B

44

Valerian root, cut

Reference number: PA/PH/Exp. 13B/T (21) 55 ANP

Text number: 2526

Direct link

13B

45

Valerian tincture

Reference number: PA/PH/Exp. 13B/T (21) 58 ANP

Text number: 1899

Direct link

13B

46

Xanthan gum

Reference number: PA/PH/Exp. CRB/T (21) 35 ANP

Text number: 1277

Direct link

CRB

47

Xylose

Reference number: PA/PH/Exp. CRB/T (21) 12 ANP

Text number: 1278

Direct link

CRB

48

Zinc acetate dihydrate

Reference number: PA/PH/Exp. 9/T (21) 30 ANP

Text number: 1482

Direct link

9