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Pharmeuropa 32.4 just released

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European Pharmacopoeia
Public enquiry
News
02 October 2020
Strasbourg, France

All new texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments on Pharmeuropa 32.4 is 31 December 2020.

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 European Pharmacopoeia (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 42 drafts published in Pharmeuropa 32.4 are:

 

Drafts published in Pharmeuropa 32.4 (end of commenting period: 31 December 2020)

Group

1

2.9.12. Sieve test

Reference number: PA/PH/Exp. POW/T (20) 15 ANP

Text number: 20912

Direct link

POW

2

2.9.7. Friability of uncoated tablets

Reference number: PA/PH/Exp. 12/T (20) 32 ANP

Text number: 20907

Direct link

12

3

5.26. Implementation of pharmacopoeial procedures

Reference number: PA/PH/Exp. MG/T (18) 9 ANP

Text number: 52600

Direct link

MG

4

Acitretin

Reference number: PA/PH/Exp. SIT/T (20) 24 ANP

Text number: 1385

Direct link

VIT

5

Air, medicinal

Reference number: PA/PH/Exp. 9G/T (20) 4 ANP

Text number: 1238

Direct link

9G

6

Ammonia (13N) injection

Reference number: PA/PH/Exp. 14/T (16) 29 ANP

Text number: 1492

Direct link

14

7

Argon

Reference number: PA/PH/Exp. 9G/T (20) 8 ANP

Text number: 2407

Direct link

9G

8

Betiatide for radiopharmaceutical preparations

Reference number: PA/PH/Exp. PRP/T (20) 8 ANP

Text number: 2551

Direct link

PRP

9

Bromazepam

Reference number: PA/PH/Exp. 10B/T (20) 28 ANP

Text number: 0879

Direct link

10B

10

Calcium gluconate for injection

Reference number: PA/PH/Exp. 9/T (19) 4 ANP

Text number: 0979

Direct link

9

11

Carbon monoxide (15O)

Reference number: PA/PH/Exp. 14/T (19) 12 ANP

Text number: 1607

Direct link

14

12

Cefoxitin sodium

Reference number: PA/PH/Exp. 7/T (15) 86 ANP

Text number: 0990

Direct link

7

13

Chinese motherwort

Reference number: PA/PH/Exp. TCM/T (12) 20 ANP

Text number: 2785

Direct link

TCM

14

Colchicine

Reference number: PA/PH/Exp. SIT/T (20) 22 ANP

Text number: 0758

Direct link

11

15

Copper tetramibi tetrafluoroborate for radiopharmaceutical preparations

Reference number: PA/PH/Exp. PRP/T (20) 5 ANP

Text number: 2547

Direct link

PRP

16

Crotamiton

Reference number: PA/PH/Exp. 11/T (20) 22 ANP

Text number: 1194

Direct link

11

17

Dronedarone hydrochloride

Reference number: PA/PH/Exp. P4/T (20) 19 ANP

Text number: 3039

Direct link

P4

18

Dydrogesterone

Reference number: PA/PH/Exp. 10B/T (20) 70 ANP

Text number: 2357

Direct link

10B

19

Felodipine

Reference number: PA/PH/Exp. 11/T (20) 41 ANP

Text number: 1013

Direct link

11

20

Flumazenil (N-[11C]methyl) injection

Reference number: PA/PH/Exp. 14/T (19) 14 ANP

Text number: 1917

Direct link

14

21

Hydroxyethyl salicylate

Reference number: PA/PH/Exp. 10D/T (20) 17 ANP

Text number: 1225

Direct link

10D

22

Influenza vaccine (split virion, inactivated)

Reference number: PA/PH/Exp. 15/T (20) 33 ANP

Text number: 0158

Direct link

15

23

Influenza vaccine (surface antigen, inactivated, prepared in cell cultures)

Reference number: PA/PH/Exp. 15/T (20) 32 ANP

Text number: 2149

Direct link

15

24

Influenza vaccine (surface antigen, inactivated)

Reference number: PA/PH/Exp. 15/T (20) 31 ANP

Text number: 0869

Direct link

15

25

l-Methionine ([11C]methyl) injection

Reference number: PA/PH/Exp. 14/T (19) 13 ANP

Text number: 1617

Direct link

14

26

Levocarnitine

Reference number: PA/PH/Exp. 10D/T (20) 36 ANP

Text number: 1339

Direct link

10D

27

Manganese sulfate monohydrate

Reference number: PA/PH/Exp. 9/T (20) 51 ANP

Text number: 1543

Direct link

9

28

Mebeverine hydrochloride

Reference number: PA/PH/Exp. 10D/T (20) 33 ANP

Text number: 2097

Direct link

10D

29

Mercaptopurine monohydrate

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

Text number: 0096

Direct link

10B

30

Mullein flower

Reference number: PA/PH/Exp. 13A/T (20) 28 ANP

Text number: 1853

Direct link

13A

31

Nitrogen

Reference number: PA/PH/Exp. 9G/T (20) 3 ANP

Text number: 1247

Direct link

9G

32

Oxygen (15O)

Reference number: PA/PH/Exp. 14/T (19) 10 ANP

Text number: 1620

Direct link

14

33

Purple coneflower herb expressed juice, stabilised with ethanol

Reference number: PA/PH/Exp. 13A/T (13) 76 ANP R2

Text number: 2282

Direct link

13A

34

Purple coneflower herb expressed juice, stabilised without ethanol

Reference number: PA/PH/Exp. 13A/T (13) 77 ANP R2

Text number: 2894

Direct link

13A

35

Raclopride ([11C]methoxy) injection

Reference number: PA/PH/Exp. 14/T (19) 15 ANP

Text number: 1924

Direct link

14

36

Radiopharmaceutical preparations

Reference number: PA/PH/Exp. 14/T (19) 41 ANP

Text number: 0125

Direct link

14

37

Rectal preparations

Reference number: PA/PH/Exp. 12/T (15) 38 ANP

Text number: 1145

Direct link

12

38

Risedronate sodium 2.5-hydrate

Reference number: PA/PH/Exp. 11/T (20) 29 ANP

Text number: 2572

Direct link

11

39

Saw palmetto fruit

Reference number: PA/PH/Exp. 13A/T (20) 57 ANP

Text number: 1848

Direct link

13A

40

Sodium acetate ([1-11C]) injection

Reference number: PA/PH/Exp. 14/T (19) 16 ANP

Text number: 1920

Direct link

14

41

Tretinoin

Reference number: PA/PH/Exp. SIT/T (20) 23 ANP

Text number: 0693

Direct link

VIT

42

Water (15O) injection

Reference number: PA/PH/Exp. 14/T (19) 11 ANP

Text number: 1582

Direct link

14

 

 

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