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EUROPEAN PHARMACOPOEIA 8.2 Contents of Supplement 8.2 CONTENTS OF SUPPLEMENT 8.2 A vertical line in the margin indicates where part of a text has been revised or corrected. A horizontal line in the margin indicates where part of a text has been deleted. However, these indications, which are not necessarily exhaustive, are given for information and do not form an official part of the texts. Editorial changes are not indicated. Individual copies of texts will not be supplied. Subscribers to the current version (printed or electronic) of the European Pharmacopoeia have access to an archive version of all previous editions of the European Pharmacopoeia. NEW TEXTS The texts below appear for the first time in the European Pharmacopoeia. They will be implemented on 1 July 2014 at the latest. GENERAL CHAPTERS 5.22. Names of herbal drugs used in traditional Chinese medicine MONOGRAPHS Vaccines for human use Diphtheria, tetanus and pertussis (acellular, component) vaccine (adsorbed, reduced antigen(s) content) (2764) Homoeopathic preparations Magnesium phosphoricum for homoeopathic preparations (2505) Monographs Brimonidine tartrate (2760) Chlormadinone acetate (2702) Esomeprazole magnesium dihydrate (2787) Human coagulation factor IX (rDNA) concentrated solution (2522) Quetiapine fumarate (2541) Valaciclovir hydrochloride, hydrated (2751) Vardenafil hydrochloride trihydrate (2782) REVISED TEXTS The texts below have been technically revised since their last publication. They will be implemented on 1 July 2014. GENERAL CHAPTERS 1. General notices 2.2.32. Loss on drying 2.4.27. Heavy metals in herbal drugs and herbal drug preparations 2.5.12. Water: semi-micro determination 2.6.21. Nucleic acid amplification techniques 2.7.4. Assay of human coagulation factor VIII 2.7.22. Assay of human coagulation factor XI 2.8.13. Pesticide residues 4. Reagents (new, revised, corrected) MONOGRAPHS General monographs Allergen products (1063) Vaccines for human use Rabies vaccine for human use prepared in cell cultures (0216) Herbal drugs and herbal drug preparations Coriander (1304) Coriander oil (1820) Eucalyptus leaf (1320) Long pepper (2453) Restharrow root (1879) Safflower flower (2386) Sage leaf, three-lobed (1561) Thyme (0865) Turpentine oil (1627) Valerian dry hydroalcoholic extract (1898) Wild thyme (1891) Yarrow (1382) Homoeopathic preparations Allium sativum for homoeopathic preparations (2023) Anacardium for homoeopathic preparations (2094) Apis for homoeopathic preparations (2024) Arsenicum album for homoeopathic preparations (1599) Aurum chloratum natronatum for homoeopathic preparations (2141) Barium chloratum for homoeopathic preparations (2142) Cadmium sulfuricum for homoeopathic preparations (2143) Calcium iodatum for homoeopathic preparations (2144) Cocculus for homoeopathic preparations (2486) Crocus for homoeopathic preparations (1624) Cuprum aceticum for homoeopathic preparations (2146) Cuprum metallicum for homoeopathic preparations (1610) Ferrum metallicum for homoeopathic preparations (2026) Kalium bichromicum for homoeopathic preparations (2501) Urtica dioica for homoeopathic preparations (2030) Monographs Alanine (0752) Amikacin (1289) Amikacin sulfate (1290) Arginine (0806) Arginine hydrochloride (0805) Cholesterol (0993) Cilastatin sodium (1408) xxvii

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Page 1: ep 8.2

EUROPEAN PHARMACOPOEIA 8.2 Contents of Supplement 8.2

CONTENTSOF SUPPLEMENT 8.2A vertical line in the margin indicates where part of a text has been revised or corrected. A horizontal line in the margin indicateswhere part of a text has been deleted. However, these indications, which are not necessarily exhaustive, are given for informationand do not form an official part of the texts. Editorial changes are not indicated.Individual copies of texts will not be supplied.Subscribers to the current version (printed or electronic) of the European Pharmacopoeia have access to an archive version of allprevious editions of the European Pharmacopoeia.

NEW TEXTS

The texts below appear for the first time in the European Pharmacopoeia. They will be implemented on 1 July 2014 at the latest.

GENERAL CHAPTERS5.22. Names of herbal drugs used in traditional Chinese

medicine

MONOGRAPHSVaccines for human useDiphtheria, tetanus and pertussis (acellular, component)vaccine (adsorbed, reduced antigen(s) content) (2764)Homoeopathic preparationsMagnesium phosphoricum for homoeopathic preparations(2505)

MonographsBrimonidine tartrate (2760)Chlormadinone acetate (2702)Esomeprazole magnesium dihydrate (2787)Human coagulation factor IX (rDNA) concentrated solution(2522)Quetiapine fumarate (2541)Valaciclovir hydrochloride, hydrated (2751)Vardenafil hydrochloride trihydrate (2782)

REVISED TEXTS

The texts below have been technically revised since their last publication. They will be implemented on 1 July 2014.

GENERAL CHAPTERS1. General notices2.2.32. Loss on drying2.4.27. Heavy metals in herbal drugs and herbal drug

preparations2.5.12. Water: semi-micro determination2.6.21. Nucleic acid amplification techniques2.7.4. Assay of human coagulation factor VIII2.7.22. Assay of human coagulation factor XI2.8.13. Pesticide residues4. Reagents (new, revised, corrected)

MONOGRAPHSGeneral monographsAllergen products (1063)Vaccines for human useRabies vaccine for human use prepared in cell cultures (0216)Herbal drugs and herbal drug preparationsCoriander (1304)Coriander oil (1820)Eucalyptus leaf (1320)Long pepper (2453)Restharrow root (1879)Safflower flower (2386)Sage leaf, three-lobed (1561)Thyme (0865)Turpentine oil (1627)

Valerian dry hydroalcoholic extract (1898)Wild thyme (1891)Yarrow (1382)Homoeopathic preparationsAllium sativum for homoeopathic preparations (2023)Anacardium for homoeopathic preparations (2094)Apis for homoeopathic preparations (2024)Arsenicum album for homoeopathic preparations (1599)Aurum chloratum natronatum for homoeopathic preparations(2141)Barium chloratum for homoeopathic preparations (2142)Cadmium sulfuricum for homoeopathic preparations (2143)Calcium iodatum for homoeopathic preparations (2144)Cocculus for homoeopathic preparations (2486)Crocus for homoeopathic preparations (1624)Cuprum aceticum for homoeopathic preparations (2146)Cuprum metallicum for homoeopathic preparations (1610)Ferrum metallicum for homoeopathic preparations (2026)Kalium bichromicum for homoeopathic preparations (2501)Urtica dioica for homoeopathic preparations (2030)MonographsAlanine (0752)Amikacin (1289)Amikacin sulfate (1290)Arginine (0806)Arginine hydrochloride (0805)Cholesterol (0993)Cilastatin sodium (1408)

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Page 2: ep 8.2

Contents of Supplement 8.2 EUROPEAN PHARMACOPOEIA 8.2

Cyanocobalamin (0547)Diclofenac potassium (1508)Diclofenac sodium (1002)Esomeprazole magnesium trihydrate (2372)Fenticonazole nitrate (1211)Fibrin sealant kit (0903)Fulvestrant (2443)Histidine (0911)Histidine hydrochloride monohydrate (0910)Human plasma (pooled and treated for virus inactivation)(1646)Indometacin (0092)Interferon gamma-1b concentrated solution (1440)

Levocabastine hydrochloride (1484)Linseed oil, virgin (1908)Macrogol stearate (1234)Magnesium gluconate (2161)Manganese gluconate (2162)Neostigmine bromide (0046)Neostigmine metilsulfate (0626)Pancreas powder (0350)Phenylalanine (0782)Rifamycin sodium (0432)Selegiline hydrochloride (1260)Tyrosine (1161)Zidovudine (1059)

CORRECTED TEXTS

The texts below have been corrected and are republished in their entirety. These corrections are to be taken into account fromthe publication date of Supplement 8.2 (1 January 2014).

MONOGRAPHSRadiopharmaceutical preparations and starting materialsfor radiopharmaceutical preparationsFludeoxyglucose (18F) injection (1325)

MonographsDutasteride (2641)Hydroxypropylbetadex (1804)Magaldrate (1539)Mannitol (0559)

TEXTS WHOSE TITLE HAS CHANGED

The titles of the following texts have been changed in Supplement 8.2.

GENERAL CHAPTERS2.4.27. Heavy metals in herbal drugs and herbal drug

preparations (previously Heavy metals in herbal drugsand fatty oils)

MONOGRAPHSHerbal drugs and herbal drug preparationsTurpentine oil (1627) (previously Turpentine oil, Pinuspinaster type)Homoeopathic preparationsAllium sativum for homoeopathic preparations (2023)(previously Garlic for homoeopathic preparations)Anacardium for homoeopathic preparations (2094) (previouslyOriental cashew for homoeopathic preparations)Apis for homoeopathic preparations (2024) (previously Honeybee for homoeopathic preparations)Arsenicum album for homoeopathic preparations (1599)(previously Arsenious trioxide for homoeopathic preparations)Aurum chloratum natronatum for homoeopathic preparations(2141) (previously Sodium tetrachloroaurate dihydrate forhomoeopathic preparations)Barium chloratum for homoeopathic preparations (2142)(previously Barium chloride dihydrate for homoeopathicpreparations)

Cadmium sulfuricum for homoeopathic preparations (2143)(previously Cadmium sulfate hydrate for homoeopathicpreparations)Calcium iodatum for homoeopathic preparations (2144)(previously Calcium iodide tetrahydrate for homoeopathicpreparations)Cocculus for homoeopathic preparations (2486) (previouslyAnamirta cocculus for homoeopathic preparations)Crocus for homoeopathic preparations (1624) (previouslySaffron for homoeopathic preparations)Cuprum aceticum for homoeopathic preparations (2146)(previously Copper acetate monohydrate for homoeopathicpreparations)Cuprum metallicum for homoeopathic preparations (1610)(previously Copper for homoeopathic preparations)Ferrum metallicum for homoeopathic preparations (2026)(previously Iron for homoeopathic preparations)Kalium bichromicum for homoeopathic preparations(2501) (previously Potassium dichromate for homoeopathicpreparations)Urtica dioica for homoeopathic preparations (2030)(previously Common stinging nettle for homoeopathicpreparations)

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