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Back Pharmeuropa 35.1 just released

EDQM Strasbourg, France 03/01/2023

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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 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

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