null Pharmeuropa 35.1 just released

EDQM Strasbourg, France 03/01/2023
Pharmeuropa 35.1 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 35.1 is 31 March 2023.

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 80 drafts published in Pharmeuropa 35.1 are listed here.

 

Drafts published in Pharmeuropa 35.1 (end of commenting period: 31 March 2023)

Group

1

2.9.3. Dissolution test for solid dosage forms
Reference number: PA/PH/Exp. 12/T (22) 2 ANP
Text number: 20903
Direct link

 
12

 2

2.9.55. Characterisation of powder behaviour during compression
Reference number: PA/PH/Exp. POW/T (21) 7 ANP
Text number: 20955
Direct link

 
POW

 3

3-O-Desacyl-4′-monophosphoryl lipid A
Reference number: PA/PH/Exp. 15/T (22) 9 ANP
Text number: 2537
Direct link

 
15V

 4

3.3.4. Sterile plastic containers for human blood and blood components
Reference number: PA/PH/Exp. 16/T (21) 15 ANP
Text number: 30304
Direct link

 
16

 5

3.3.7. Sets for the transfusion of blood and blood components
Reference number: PA/PH/Exp. 16/T (21) 16 ANP
Text number: 30307
Direct link

 
16

 6

5.1.10. Guidelines for using the test for bacterial endotoxins
Reference number: PA/PH/Exp. BET/T (22) 2 ANP
Text number: 50110
Direct link

 
BET

 7

5.1.13. PYROGENICITY
Reference number: PA/PH/Exp. BET/T (21) 13 ANP
Text number: 50113
Direct link

 
BET

 8

5.2.11. Carrier proteins for the production of conjugated polysaccharide vaccines for human use
Reference number: PA/PH/Exp. 15/T (22) 10 ANP
Text number: 50211
Direct link

 
15

 9

Allergen products
Reference number: PA/PH/Exp. ALG/T (22) 5 ANP
Text number: 1063
Direct link

 
ALG

 10

Aluminium phosphate gel
Reference number: PA/PH/Exp. 9/T (22) 41 ANP
Text number: 2166
Direct link

 
9

 11

Aluminium phosphate hydrate
Reference number: PA/PH/Exp. 9/T (22) 40 ANP
Text number: 1598
Direct link

 
9

 12

Amikacin sulfate
Reference number: PA/PH/Exp. 7/T (22) 23 ANP
Text number: 1290
Direct link

 
7

 13

Anti-T lymphocyte immunoglobulin for human use, animal
Reference number: PA/PH/Exp. 6B/T (22) 19 ANP
Text number: 1928
Direct link

 
6B

 14

Anticoagulant and preservative solutions for human blood
Reference number: PA/PH/Exp. 6B/T (22) 8 ANP
Text number: 0209
Direct link

 
6B

 15

Atorvastatin calcium
Reference number: PA/PH/Exp. 10A/T (22) 77 ANP
Text number: 2191
Direct link

 
10A

 16

Black cohosh
Reference number: PA/PH/Exp. 13B/T (22) 42 ANP
Text number: 2069
Direct link

 
13B

 17

Butylhydroxyanisole
Reference number: PA/PH/Exp. 10A/T (18) 193 ANP
Text number: 0880
Direct link

 
10A

 18

Butylhydroxytoluene
Reference number: PA/PH/Exp. 10A/T (18) 192 ANP
Text number: 0581
Direct link

 
10A

 19

Calcium glycerophosphate
Reference number: PA/PH/Exp. 9/T (22) 39 ANP
Text number: 0980
Direct link

 
9

 20

Calcium levulinate dihydrate
Reference number: PA/PH/Exp. 10D/T (22) 22 ANP
Text number: 1296
Direct link

 
10D

 21

Chloramphenicol sodium succinate
Reference number: PA/PH/Exp. 7/T (22) 22 ANP
Text number: 0709
Direct link

 
7

 22

Chloroquine phosphate
Reference number: PA/PH/Exp. 11/T (22) 35 ANP
Text number: 0544
Direct link

 
11

 23

Colchicine
Reference number: PA/PH/Exp. 11/T (22) 48 ANP
Text number: 0758
Direct link

 
11

 24

Colistimethate sodium
Reference number: PA/PH/Exp. 7/T (22) 27 ANP
Text number: 0319
Direct link

 
7

 25

Dicloxacillin sodium monohydrate
Reference number: PA/PH/Exp. 7/T (22) 28 ANP
Text number: 0663
Direct link

 
7

 26

Diphtheria, tetanus, pertussis (acellular, component) and haemophilus type b conjugate vaccine (adsorbed)
Reference number: PA/PH/Exp. 15/T (22) 19 ANP
Text number: 1932
Direct link

 
15

 27

Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and haemophilus type b conjugate vaccine (adsorbed)
Reference number: PA/PH/Exp. 15/T (22) 15 ANP
Text number: 2067
Direct link

 
15

 28

Diphtheria, tetanus, pertussis (acellular, component), poliomyelitis (inactivated) and haemophilus type b conjugate vaccine (adsorbed)
Reference number: PA/PH/Exp. 15/T (22) 20 ANP
Text number: 2065
Direct link

 
15

 29

Etravirine
Reference number: PA/PH/Exp. P4/T (21) 32 ANP
Text number: 3121
Direct link

 
P4

 30

Flucloxacillin sodium monohydrate
Reference number: PA/PH/Exp. 7/T (22) 21 ANP
Text number: 0668
Direct link

 
7

 31

Glucose
Reference number: PA/PH/Exp. CRB/T (22) 33 ANP
Text number: 0177
Direct link

 
CRB

 32

Glucose monohydrate
Reference number: PA/PH/Exp. CRB/T (22) 34 ANP
Text number: 0178
Direct link

 
CRB

 33

Haemodialysis, solutions for
Reference number: PA/PH/Exp. DIA/T (21) 3 ANP
Text number: 0128
Direct link

 
DIA

 34

Haemofiltration and haemodiafiltration, solutions for
Reference number: PA/PH/Exp. DIA/T (21) 4 ANP
Text number: 0861
Direct link

 
DIA

 35

Haemophilus type b and meningococcal group C conjugate vaccine
Reference number: PA/PH/Exp. 15/T (22) 22 ANP
Text number: 2622
Direct link

 
15

 36

Haemophilus type b conjugate vaccine
Reference number: PA/PH/Exp. 15/T (22) 12 ANP
Text number: 1219
Direct link

 
15

 37

Hepatitis B vaccine (rDNA)
Reference number: PA/PH/Exp. 15/T (22) 11 ANP
Text number: 1056
Direct link

 
15

 38

Human albumin solution
Reference number: PA/PH/Exp. 6B/T (22) 9 ANP
Text number: 0255
Direct link

 
6B

 39

Human antithrombin III concentrate
Reference number: PA/PH/Exp. 6B/T (22) 13 ANP
Text number: 0878
Direct link

 
6B

 40

Human C1-esterase inhibitor
Reference number: PA/PH/Exp. 6B/T (22) 23 ANP
Text number: 2818
Direct link

 
6B

 41

Human coagulation factor XI
Reference number: PA/PH/Exp. 6B/T (22) 17 ANP
Text number: 1644
Direct link

 
6B

 42

Human coagulation factor IX
Reference number: PA/PH/Exp. 6B/T (22) 15 ANP
Text number: 1223
Direct link

 
6B

 43

Human coagulation factor VII
Reference number: PA/PH/Exp. 6B/T (22) 16 ANP
Text number: 1224
Direct link

 
6B

 44

Human coagulation factor VIII
Reference number: PA/PH/Exp. 6B/T (22) 10 ANP
Text number: 0275
Direct link

 
6B

 45

Human fibrinogen
Reference number: PA/PH/Exp. 6B/T (22) 7 ANP
Text number: 0024
Direct link

 
6B

 46

Human normal immunoglobulin for intramuscular administration
Reference number: PA/PH/Exp. 6B/T (22) 11 ANP
Text number: 0338
Direct link

 
6B

 47

Human normal immunoglobulin for intravenous administration
Reference number: PA/PH/Exp. 6B/T (22) 14 ANP
Text number: 0918
Direct link

 
6B

 48

Human normal immunoglobulin for subcutaneous administration
Reference number: PA/PH/Exp. 6B/T (22) 22 ANP
Text number: 2788
Direct link

 
6B

 49

Human plasma (pooled and treated for virus inactivation)
Reference number: PA/PH/Exp. 6B/T (22) 18 ANP
Text number: 1646
Direct link

 
6B

 50

Human prothrombin complex
Reference number: PA/PH/Exp. 6B/T (22) 12 ANP
Text number: 0554
Direct link

 
6B

 51

Human von Willebrand factor
Reference number: PA/PH/Exp. 6B/T (22) 20 ANP
Text number: 2298
Direct link

 
6B

 52

Human α-1-proteinase inhibitor
Reference number: PA/PH/Exp. 6B/T (22) 21 ANP
Text number: 2387
Direct link

 
6B

 53

Immunosera for human use, animal
Reference number: PA/PH/Exp. 15/T (22) 8 ANP
Text number: 0084
Direct link

 
15

 54

Intravesical preparations
Reference number: PA/PH/Exp. 12/T (22) 8 ANP
Text number: 2811
Direct link

 
12

 55

Kanamycin acid sulfate
Reference number: PA/PH/Exp. 7/T (22) 25 ANP
Text number: 0033
Direct link

 
7

 56

Kanamycin monosulfate monohydrate
Reference number: PA/PH/Exp. 7/T (22) 24 ANP
Text number: 0032
Direct link

 
7

 57

Meningococcal group A, C, W135 and Y conjugate vaccine
Reference number: PA/PH/Exp. 15/T (22) 23 ANP
Text number: 3066
Direct link

 
15

 58

Meningococcal group C conjugate vaccine
Reference number: PA/PH/Exp. 15/T (22) 21 ANP
Text number: 2112
Direct link

 
15

 59

Meningococcal polysaccharide vaccine
Reference number: PA/PH/Exp. 15/T (22) 17 ANP
Text number: 0250
Direct link

 
15

 60

Parenteral preparations
Reference number: PA/PH/Exp. 12/T (22) 7 ANP
Text number: 0520
Direct link

 
12

 61

Pefloxacin mesilate dihydrate
Reference number: PA/PH/Exp. 10A/T (22) 44 ANP
Text number: 1460
Direct link

 
10A

 62

Peritoneal dialysis, solutions for
Reference number: PA/PH/Exp. DIA/T (21) 5 ANP
Text number: 0862
Direct link

 
DIA

 63

Pneumococcal polysaccharide conjugate vaccine (adsorbed)
Reference number: PA/PH/Exp. 15/T (22) 16 ANP
Text number: 2150
Direct link

 
15

 64

Pneumococcal polysaccharide vaccine
Reference number: PA/PH/Exp. 15/T (22) 18 ANP
Text number: 0966
Direct link

 
15

 65

Polymyxin B sulfate
Reference number: PA/PH/Exp. 7/T (22) 26 ANP
Text number: 0203
Direct link

 
7

 66

Preparations for irrigation
Reference number: PA/PH/Exp. 12/T (22) 9 ANP
Text number: 1116
Direct link

 
12

 67

Rabies vaccine for human use prepared in cell cultures
Reference number: PA/PH/Exp. 15/T (22) 14 ANP
Text number: 0216
Direct link

 
15

 68

Radiopharmaceutical preparations
Reference number: PA/PH/Exp. 14/T (22) 27 ANP
Text number: 0125
Direct link

 
14

 69

Rosemary leaf
Reference number: PA/PH/Exp. 13A/T (15) 22 ANP R2
Text number: 1560
Direct link

 
13A

70 

Salmonella Enteritidis vaccine (live, oral) for chickens
Reference number: PA/PH/Exp. 15V/T (22) 25 ANP
Text number: 2520
Direct link

 
15V

 71

Salmonella Typhimurium vaccine (live, oral) for chickens
Reference number: PA/PH/Exp. 15V/T (22) 24 ANP
Text number: 2521
Direct link

 
15V

 72

Sesame Seed
Reference number: PA/PH/Exp. 13B/T (19) 39 ANP
Text number: 2979
Direct link

 
13B

 73

Sodium citrate dihydrate
Reference number: PA/PH/Exp. 9/T (22) 30 ANP
Text number: 0412
Direct link

 
9

 74

Sodium selenite
Reference number: PA/PH/Exp. 9/T (22) 42 ANP
Text number: 2740
Direct link

 
9

 75

Solutions for organ preservation
Reference number: PA/PH/Exp. 12/T (22) 10 ANP
Text number: 1264
Direct link

 
12

 76

Substances for pharmaceutical use
Reference number: PA/PH/Exp. BET/T (21) 6 ANP
Text number: 2034
Direct link

 
PCM

 77

Sugar spheres
Reference number: PA/PH/Exp. CRB/T (22) 50 ANP
Text number: 1570
Direct link

 
CRB

 78

Technetium (99mTc) human albumin injection
Reference number: PA/PH/Exp. 14/T (22) 28 ANP
Text number: 0640
Direct link

 
14

 79

Tick-borne encephalitis vaccine (inactivated)
Reference number: PA/PH/Exp. 15/T (22) 13 ANP
Text number: 1375
Direct link

 
15

 80

Vaccines for human use
Reference number: PA/PH/Exp. 15/T (22) 7 ANP
Text number: 0153
Direct link

 
15