Back Pharmeuropa 31.4 just released

EDQM Strasbourg, France 11/10/2019
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All new texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation.

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 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. Thus changes to general texts might 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 53 drafts published in Pharmeuropa 31.4 are:

Drafts published in Pharmeuropa 31.4 (end of commenting period: 30.12.2019) 

 

  1. 2.4.20. Determination of elemental impurities

Reference number: PA/PH/Exp. HM/T (17) 9 ANP

Text number: 20420

  1. 2.4.33. Tetrabutylammonium in radiopharmaceutical preparations

Reference number: PA/PH/Exp. 14/T (18) 12 ANP

Text number: 20433

  1. 2.7.36. Assay of Bet v 1 allergen

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

Text number: 20736

  1. 2.9.27. Uniformity of delivered doses from multidose containers

Reference number: PA/PH/Exp. 12/T (16) 46 ANP

Text number: 20927

  1. 2.9.34. Bulk density of powders

Reference number: PA/PH/Exp. POW/T (16) 5 ANP

Text number: 20934

  1. 2.9.36. Powder flow

Reference number: PA/PH/Exp. POW/T (16) 7 ANP

Text number: 20936

  1. 2.9.53. Particulate contamination: sub-visible particles in non-injectable liquid preparations

Reference number: PA/PH/Exp. 12/T (17) 19 ANP

Text number: 20953

  1. 3.2.2. Plastic containers and closures for pharmaceutical use

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

Text number: 30202

  1. 5.18. Methods of pretreatment for preparing traditional Chinese drugs: general information

Reference number: PA/PH/Exp. TCM/T (09) 80 ANP

Text number: 51800

  1. Alfacalcidol

Reference number: PA/PH/Exp. VIT/T (19) 38 ANP

Text number: 1286

  1. Betamethasone sodium phosphate

Reference number: PA/PH/Exp. SIT/T (19) 25 ANP

Text number: 0810

  1. Bisacodyl

Reference number: PA/PH/Exp. 11/T (19) 48 ANP

Text number: 0595

  1. Calcium acetate

Reference number: PA/PH/Exp. 9/T (19) 29 ANP

Text number: 2128

  1. Calcium stearate

Reference number: PA/PH/Exp. 9/T (19) 30 ANP

Text number: 0882

  1. Cellulose, microcrystalline

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

Text number: 0316

  1. Cellulose, powdered

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

Text number: 0315

  1. Chaenomeles fruit

Reference number: PA/PH/Exp. TCM/T (11) 32 ANP

Text number: 2713

  1. Clotrimazole

Reference number: PA/PH/Exp. 10A/T (18) 178 ANP

Text number: 0757

  1. Copper sulfate

Reference number: PA/PH/Exp. 9/T (19) 33 ANP

Text number: 0893

  1. Croscarmellose sodium

Reference number: PA/PH/Exp. CEL/T (17) 13 ANP

Text number: 0985

  1. Cyclophosphamide monohydrate

Reference number: PA/PH/Exp. 11/T (08) 52 ANP

Text number: 0711

  1. Dacarbazine

Reference number: PA/PH/Exp. 10A/T (18) 5 ANP

Text number: 1691

  1. Dexamethasone sodium phosphate

Reference number: PA/PH/Exp. SIT/T (19) 26 ANP

Text number: 0549

  1. Ear preparations

Reference number: PA/PH/Exp. 12/T (17) 20 ANP

Text number: 0652

  1. Erythropoietin concentrated solution

Reference number: PA/PH/Exp. 6/T (19) 9 ANP

Text number: 1316

  1. Eucalyptus oil

Reference number: PA/PH/Exp. 13A/T (19) 35 ANP

Text number: 0390

  1. Eye preparations

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

Text number: 1163

  1. Ferrous fumarate

Reference number: PA/PH/Exp. 9/T (19) 35 ANP

Text number: 0902

  1. Ferrous gluconate

Reference number: PA/PH/Exp. 9/T (19) 34 ANP

Text number: 0493

  1. Ferrous sulfate heptahydrate

Reference number: PA/PH/Exp. 9/T (19) 32 ANP

Text number: 0083

  1. Gallium (68Ga) edotreotide injection

Reference number: PA/PH/Exp. 14/T (18) 19 ANP

Text number: 2482

  1. Gliclazide

Reference number: PA/PH/Exp. 10A/T (19) 121 ANP

Text number: 1524

  1. Glipizide

Reference number: PA/PH/Exp. SIT/T (19) 23 ANP

Text number: 0906

  1. Liquid preparations for cutaneous application

Reference number: PA/PH/Exp. 12/T (16) 33 ANP

Text number: 0927

  1. Magnesium aluminometasilicate

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

Text number: 2854

  1. Magnesium carbonate, heavy

Reference number: PA/PH/Exp. 9/T (19) 31 ANP

Text number: 0043

  1. Methylaminolevulinate hydrochloride

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

Text number: 3073

  1. Narrow-leaved coneflower root

Reference number: PA/PH/EXP. 13A/T (19) 39 ANP

Text number: 1821

  1. Olive leaf

Reference number: PA/PH/Exp. 13B/T (19) 51 ANP

Text number: 1878

  1. Orientvine stem

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

Text number: 2450

  1. Oxybutynin hydrochloride

Reference number: PA/PH/Exp. 10D/T (19) 33 ANP

Text number: 1354

  1. PSMA-1007 (18F) injection

Reference number: PA/PH/Exp. 14/T (18) 33 ANP

Text number: 3116

  1. Pale coneflower root

Reference number: PA/PH/Exp. 13A/T (19) 40 ANP

Text number: 1822

  1. Prednisolone sodium phosphate

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

Text number: 0735

  1. Purple coneflower herb

Reference number: PA/PH/Exp. 13A/T (19) 41 ANP

Text number: 1823

  1. Purple coneflower root

Reference number: PA/PH/Exp. 13A/T (19) 42 ANP

Text number: 1824

  1. Teriflunomide

Reference number: PA/PH/Exp. P4/T (16) 35 ANP

Text number: 3036

  1. Ticagrelor tablets

Reference number: PA/PH/Exp. P4/T (18) 30 ANP

Text number: 3097

  1. Titanium dioxide

Reference number: PA/PH/Exp. 9/T (19) 27 ANP

Text number: 0150

  1. Vaccines for human use

Reference number: PA/PH/Exp. 15/T (19) 47 ANP

Text number: 0153

  1. Valganciclovir hydrochloride

Reference number: PA/PH/Exp. 10C/T (18) 34 ANP

Text number: 2930

  1. Zidovudine

Reference number: PA/PH/Exp. 10C/T (19) 35 ANP

Text number: 1059

  1. Zinc stearate

Reference number: PA/PH/Exp. 9/T (19) 28 ANP

Text number: 0306