EUROPEAN PHARMACOPOEIA 9.0 Contents of the 9th Edition IV. CONTENTS OF THE 9th EDITION The 9th Edition consists of new texts as well as all current Lines in the margin that were present in revised or corrected texts from the 8th Edition, some of which have been revised texts in the previous edition are deleted with each new edition. or corrected. From the 9th Edition, corrections that are indicated by the note Lists of the monographs and general chapters that, for the ‘corrected X.X’ under the version date are to be taken into 9th Edition, are new, revised or corrected, have undergone accountassoonaspossibleandnotlaterthantheendofthe pharmacopoeial harmonisation or have had their titles month following the month of publication of the volume. th changed, are given below. From the 9 Edition, a barcode is included at the start of each text, providing a link to further information on the text The version date (for example 01/2017 for a text that is new or (e.g. the Knowledge database) for smartphones and tablets revised for the 9th Edition), completed by ‘corrected X.X’ if a withacameraandabarcodereaderapp. corrected version of the text has subsequently been published For the 9th Edition, the following decisions and systematic in Supplement X.X, and the reference number (4 digits for modifications to the texts of the European Pharmacopoeia monographs and 5 digits for general chapters) are specified have been made. abovethetitleofeachmonographandgeneralchapter.The – Tests for heavy metals have been deleted from the version date, completed by ‘corrected X.X’ if appropriate, monographs concerned (see under ‘Useful information’ in makes it possible to identify the successive versions of texts in Pharmeuropa Online). different editions. – ‘Anhydrous’ has been deleted from the title of the Since the 7th Edition,ifatexthasnotbeenrevisedforanew monographs concerned (see under ‘Useful information’ in edition, the version date published in the previous edition is Pharmeuropa Online). retained in order to improve traceability. The volume in which – Appearance and granulometry have been deleted from the the version was first published is stated in the Knowledge descriptions of silica gels for chromatography in general database on the EDQM website. chapter 4. Reagents. A vertical line in the margin indicates where part of a text has – The introduction of the ‘Functionality-related been revised or corrected. A horizontal line in the margin characteristics’ section has been updated according to the indicates where part of a text has been deleted. However, these Style Guide 2014 in the monographs concerned. indications, which are not necessarily exhaustive, are given for – All impurities in monographs are now represented informationonlyanddonotformanofficialpartofthetexts. individually with complete graphic formulae, where Editorialchangesarenotindicated. possible. Individual copies of texts published in this edition will not be supplied. Subscribers to the current version (printed or electronic) of the European Pharmacopoeia have access to an online archive version of all previous editions of the European Pharmacopoeia. A list of new reagents published during the course of this edition is available under ‘Useful information’ in Pharmeuropa Online. NEW TEXTS The following texts appear for the first time in the European Pharmacopoeia. They will be implemented on 1 January 2017 at the latest. GENERAL CHAPTERS Codonopsis root (2714) 2.7.35. Immunonephelometry for vaccine component assay Horse-chestnut (1830) 2.8.25. High-performance thin-layer chromatography of Horse-chestnut dry extract, standardised (1829) herbal drugs and herbal drug preparations Paeony root, red (2425) 5.2.12. Raw materials of biological origin for the production Paeony root, white (2424) of cell-based and gene therapy medicinal products Polygonumcuspidatumrhizomeandroot(2724) 5.2.13. Healthy chicken flocks for the production of Polygonum orientale fruit (2726) inactivated vaccines for veterinary use Uncaria stem with hooks (2729) MONOGRAPHS Zanthoxylum bungeanum pericarp (2656) Vaccines for veterinary use Homoeopathic preparations Infectious bovine rhinotracheitis vaccine (inactivated) (2674) Magnesiumfluoratumforhomoeopathicpreparations(2676) Herbal drugs and herbal drug preparations Monographs Akebia stem (2472) Animal epithelia and outgrowths for allergen products (2621) Cape jasmine fruit (2565) Aprepitant (2757) xxi Contents of the 9th Edition EUROPEAN PHARMACOPOEIA 9.0 Clopidogrel besilate (2790) Moulds for allergen products (2626) Clopidogrel hydrochloride (2791) Pollens for allergen products (2627) Escitalopram (2758) Tacalcitol monohydrate (2272) Hydroxychloroquine sulfate (2849) Hymenoptera venoms for allergen products (2623) Temozolomide (2780) Irinotecan hydrochloride trihydrate (2675) Teriparatide (2829) Mites for allergen products (2625) REVISED TEXTS Thefollowingtextshavebeentechnicallyrevisedsincetheir last publication. They will be implemented on 1 January 2017. GENERAL CHAPTERS Mycoplasma gallisepticum vaccine (inactivated) (1942) 2.4.24. Identification and control of residual solvents Neonatal piglet colibacillosis vaccine (inactivated) (0962) 2.5.28. Water in gases Neonatal ruminant colibacillosis vaccine (inactivated) (0961) Newcastle disease vaccine (inactivated) (0870) 2.9.6. Uniformity of content of single-dose preparations Pasteurella vaccine (inactivated) for sheep (2072) 4. Reagents Porcine enzootic pneumonia vaccine (inactivated) (2448) 5.2.3. Cell substrates for the production of vaccines for Porcine influenza vaccine (inactivated) (0963) human use Porcine parvovirosis vaccine (inactivated) (0965) 5.8. Pharmacopoeial harmonisation Rabbit haemorrhagic disease vaccine (inactivated) (2325) Rabies vaccine (inactivated) for veterinary use (0451) MONOGRAPHS Salmonella Enteritidis vaccine (inactivated) for chickens General monographs (1947) Allergen products (1063) Salmonella Typhimurium vaccine (inactivated) for chickens Vaccines for human use (0153) (2361) Vaccines for veterinary use (0062) Swine erysipelas vaccine (inactivated) (0064) Dosage forms Vibriosis (cold-water) vaccine (inactivated) for salmonids (1580) Powders for cutaneous application (1166) Vibriosis vaccine (inactivated) for salmonids (1581) Tampons, medicated (1155) Vaccines for veterinary use Yersiniosis vaccine (inactivated) for salmonids (1950) Herbal drugs and herbal drug preparations Aujeszky’s disease vaccine (inactivated) for pigs (0744) Aloes, Cape (0258) Avian infectious bronchitis vaccine (inactivated) (0959) Birch leaf (1174) Avian infectious bursal disease vaccine (inactivated) (0960) Butcher’s broom (1847) Avian paramyxovirus 3 vaccine (inactivated) for turkeys (1392) Cascara dry extract, standardised (1844) Bovine leptospirosis vaccine (inactivated) (1939) Chamomile flower, Roman (0380) Bovine viral diarrhoea vaccine (inactivated) (1952) Common selfheal fruit-spike (2439) Calf coronavirus diarrhoea vaccine (inactivated) (1953) Mastic (1876) Calf rotavirus diarrhoea vaccine (inactivated) 1954) St. John’s wort (1438) Canine adenovirus vaccine (inactivated) (1298) St. John’s wort dry extract, quantified (1874) Canine leptospirosis vaccine (inactivated) (0447) Homoeopathic preparations Canine parvovirosis vaccine (inactivated) (0795) Homoeopathic preparations (1038) Eggdropsyndrome’76vaccine(inactivated)(1202) Methods of preparation of homoeopathic stocks and Equine herpesvirus vaccine (inactivated) (1613) potentisation (2371) Equine influenza vaccine (inactivated) (0249) Mother tinctures for homoeopathic preparations (2029) Feline calicivirosis vaccine (inactivated) (1101) Pillules for homoeopathic preparations (2153) Feline chlamydiosis vaccine (inactivated) (2324) Agaricus phalloides for homoeopathic preparations (2290) Feline infectious enteritis (feline panleucopenia) vaccine Ammonium carbonicum for homoeopathic preparations (inactivated) (0794) (2916) Feline leukaemia vaccine (inactivated) (1321) Aurum chloratum natronatum for homoeopathic preparations Feline viral rhinotracheitis vaccine (inactivated) (1207) (2141) Foot-and-mouth disease (ruminants) vaccine (inactivated) Barium chloratum for homoeopathic preparations (2142) (0063) Calcium iodatum for homoeopathic preparations (2144) Fowl cholera vaccine (inactivated) (1945) Ignatia for homoeopathic preparations (2513) Furunculosis vaccine (inactivated, oil-adjuvanted, injectable) Magnesium phosphoricum for homoeopathic preparations for salmonids (1521) (2505) Infectious chicken anaemia vaccine (live) (2038) Nux-vomica for homoeopathic preparations (2514) Mannheimia vaccine (inactivated) for cattle (1944) Monographs Mannheimia vaccine (inactivated) for sheep (1946) Abacavir sulfate (2589) xxii EUROPEAN PHARMACOPOEIA 9.0 Contents of the 9th Edition Acamprosate calcium (1585) Atorvastatin calcium trihydrate (2191) Acarbose (2089) Azithromycin (1649) Acebutolol hydrochloride (0871) Barium sulfate (0010) Aceclofenac (1281) Basic butylated methacrylate copolymer (1975) Acemetacin (1686) Beclometasone dipropionate (0654) Acesulfame potassium (1282) Benazepril hydrochloride (2388) Acetazolamide (0454) Benserazide hydrochloride (1173) Acetic acid, glacial (0590) Bentonite (0467) Acetylcholine chloride (1485) Benzbromarone (1393) Acetylcysteine (0967) Benzoic acid (0066) Acetylsalicylic acid (0309) Betacarotene (1069) N-Acetyltryptophan (1383) Betadex (1070) N-Acetyltyrosine (1384) Betahistine mesilate (1071) Acitretin (1385) Betaxolol hydrochloride (1072) Adapalene (2445) Bezafibrate (1394) Adenine (0800) Bicalutamide (2196) Adipic acid