European Pharmacopoeia 11th Edition (11.2)

The European Pharmacopoeia (Ph. Eur.) Supplement 11.2 is now available.

This volume is included in the 2023 subscription (11.0, 11.1 and 11.2) to the 11th Edition of the Ph. Eur. Subscriptions for electronic versions are already available.

The 11th edition of the European Pharmacopoeia (EP), main volume and supplements, is legally binding and details the qualitative and quantitative composition of medicines, the tests to be carried out on medicines, the raw materials used in the production of medicines and on the intermediates of synthesis.

The EP is a single reference work for the quality control of medicines in Europe. All producers of medicines or substances for pharmaceutical use must apply the quality standards of the European Pharmacopoeia for the marketing and use of these products in Europe.

Key features:

• Applicable in 39 European countries and used in over 120 worldwide.
• Delivers crucial information earlier than any other Pharmacopoeia.
• Provides new and revised text
• Available in print and electronic versions, with direct access to complementary information (EDQM Knowledge Database).

EUROPEAN PHARMACOPOEIA (PH. EUR.) 11TH EDITION 2024

• The European Pharmacopoeia is a unique reference work for the control of medicines in the States signatory to the Convention on their preparation and quality.
• Official published standards provide a legal and scientific basis for quality control during the development, production and marketing processes.
• They concern the qualitative and quantitative composition and tests to be carried out on medicines, the raw materials used in the production of medicines and synthesis intermediates. All producers of medicines and/or substances for pharmaceutical use must therefore apply these quality standards to market their products in states that are signatories to the Convention.
• The European Pharmacopoeia is widely used internationally. As globalization and the expansion of international trade present an increasing need to develop global quality standards for medicines, the Commission works closely with all users of the Pharmacopoeia around the world.

THE 11th EDITION IN SUMMARY

1. New edition, official in 39 European countries from January 1, 2023 and applied in more than 130 countries worldwide ;
2. Continuously updated and modernized to meet users' needs;
3. The 11th Edition (including Supplement 11.3) of the European Pharmacopoeia contains:2485 monographs (including pharmaceutical forms);
4. 388 general texts (including general monographs and analysis methods);
5. Over 2890 reagent descriptions .

CONTENTS OF SUPPLEMENT 11.2 

• Lists of the monographs and general chapters that, for supplement 11.2, are new, revised or corrected or have had their titles changed, are given below. As of the 11th Edition, all revised, corrected or deleted parts of a text published in the online version of the European Pharmacopoeia are indicated by change marks in the form of triangles. 
• For reasons of readability, these triangles are not shown in the print version. Corrected texts are to be taken into account as soon as possible and not later than the end of the month following the month of publication of the edition or supplement. 
• New and revised texts are to be taken into account not later than the implementation date. A QR code is included at the start of each text, providing a link to further information on the text (stored in the Knowledge database) for smartphones and tablets with a camera and a compatible app. Individual copies of texts published in this edition will not be supplied. 
• Subscribers to the current version (print or online) of the European Pharmacopoeia have access to an online archive version of all obsolete editions and supplements of the European Pharmacopoeia in PDF format. 

MONOGRAPHS

Herbal drugs and herbal drug preparations Pumpkin seed (2941) 

Monographs Mirabegron (3132) 

Propylene glycol monocaprylate (2799) 

Saxagliptin monohydrate (3136) 

GENERAL CHAPTERS 

4. Reagents 

MONOGRAPHS 

• General monographs Monoclonal antibodies for human use (2031) 
• Vaccines for veterinary use Clostridium botulinum vaccine for veterinary use (0360) 
• Herbal drugs and herbal drug preparations Goldenrod (1892) 
• Goldenrod, European (1893) 
• Serratula coronata herb (2754) 
• Monographs Ascorbic acid (0253) 
• Bupivacaine hydrochloride (0541) 
• Calcium acetate (2128) 
• Calcium ascorbate dihydrate (1182) 
• Calcium chloride dihydrate (0015) 
• Calcium chloride hexahydrate (0707) 
• Calcium pantothenate (0470) 
• Clindamycin phosphate (0996) 
• Clodronate disodium tetrahydrate (1777) 
• Cyclophosphamide monohydrate (0711) 
• Ether (0650) 
• Flunarizine dihydrochloride (1722) 
• Heparins, low-molecular-mass (0828) 
• Lysine acetate (2114) 
• Miconazole nitrate (0513) 
• Oxytocin (0780) 
• Pemetrexed disodium heptahydrate (2637) 
• Pemetrexed disodium 2.5-hydrate (3046) 
• Polysorbate 20 (0426) 
• Polysorbate 40 (1914) 
• Polysorbate 60 (0427) 
• Polysorbate 80 (0428) 
• Prednisone (0354) 
• Promazine hydrochloride (1365) 
• Propylthiouracil (0525) 
• Riboflavin sodium phosphate hydrate (0786) 
• Salmeterol xinafoate (1765) 
• Sodium ascorbate (1791) 
• Sodium starch glycolate (type A) (0983) 
• Sodium starch glycolate (type B) (0984) 
• Somatropin (0951) 
• Somatropin concentrated solution (0950) 
• Somatropin injection (2370) 
• Somatropin powder for injection (0952) 
• Starch, hydroxypropyl (2165) 
• Starch, hydroxypropyl, pregelatinised (2645) 
• Thiopental sodium and sodium carbonate (0212) 
• Titanium dioxide (0150) 
• Yohimbine hydrochloride (2172)

CORRECTED TEXTS 

The following texts have been corrected for Supplement 11.2 and specify ‘corrected 11.2’ above the title.

MONOGRAPHS 

Herbal drugs and herbal drug preparations Arnica flower (1391) 

Monographs Deferiprone (2236) 

Stearic acid (1474) 

Triethyl citrate (1479)