EP8.7增补内容EP8.7增补内容

EP8.7增补内容

CONTENTS OF SUPPLEMENT 8.7

EP8.7增补内容

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

新增内容

The texts below appear for the first time in the European Pharmacopoeia. They will be implemented on 1 April 2016 at the latest.

以下内容首次出现在欧洲药典中。最迟实施日期为2016年4月1日。

GENERAL CHAPTERS

2.5.41. Methyl, ethyl and isopropyl benzenesulfonate in active substances

2.7.34. Assay of human C1-esterase inhibitor

5.19. Extemporaneous preparation of radiopharmaceuticals

5.21. Chemometric methods applied to analytical data 分析数据中应用的化学计量法

MONOGRAPHS

Vaccines for human use

Haemophilus type b and meningococcal group C conjugate vaccine (2622)

Radiopharmaceutical preparations and starting materials for radiopharmaceutical preparations

Technetium (99mTc) oxidronate injection (2376)

Herbal drugs and herbal drug preparations

Aucklandia root (1797)

Homoeopathic preparations

Acidum picrinicum for homoeopathic preparations (2695)

Histaminum for homoeopathic preparations (2671)

Monographs

Cisatracurium besilate (2763)	苯磺顺阿曲库胺
Dienogest (2732)	地诺孕素
Entecavir monohydrate (2815)	恩替卡韦一水合物
Gadobutrol monohydrate (2735)	钆布醇一水合物
Gefitinib (2866)	吉非替尼
Human C1-esterase inhibitor (2818)	人用C1酯酶抑制剂
Hydroxypropylcellulose, low-substituted (2083)	羟丙纤维素，低取代
Pregabalin (2777)	普瑞巴林
Rabeprazole sodium (2868)	雷贝拉唑钠<抗溃疡病药>
Rabeprazole sodium hydrate (2331)	雷贝拉唑钠水合物
Ropinirole hydrochloride (2604)	盐酸罗匹尼罗<抗震颤麻痹药>
Sitagliptin phosphate monohydrate (2778)	磷酸西格列汀一水合物
Sitagliptin tablets (2927)	西格列汀片剂
Sodium lauroylsarcosinate for external use (2542)	外用月桂酰肌氨酸钠
Thiocolchicoside crystallised from ethanol (2896)	乙醇中结晶的硫代秋水仙碱苷
Thiocolchicoside hydrate (2814)	硫代秋水仙碱苷水合物

REVISED TEXTS

修订内容

The texts below have been technically revised since their last publication. They will be implemented on 1 April 2016.

以下内容有技术性修订，实施日期为2016年4月1日。

GENERAL CHAPTERS

2.2.31. Electrophoresis 电沪

2.2.48. Raman spectroscopy 拉曼色谱

2.5.38. Methyl, ethyl and isopropyl methanesulfonate in active substances

2.6.15. Prekallikrein activator 前激肽释放酶激活剂

4. Reagents 试剂

5.8. Pharmacopoeial harmonization 药典协调

5.22. Names of herbal drugs used in traditional Chinese medicine 传统中药中所用草药名

MONOGRAPHS

Vaccines for human use

Haemophilus type b conjugate vaccine (1219)

Meningococcal group C conjugate vaccine (2112)

Meningococcal polysaccharide vaccine (0250)

Pneumococcal polysaccharide conjugate vaccine (adsorbed) (2150)

Pneumococcal polysaccharide vaccine (0966)

Typhoid polysaccharide vaccine (1160)

Herbal drugs and herbal drug preparations

Boldo leaf (1396)

Boldo leaf dry extract (1816)

Ipecacuanha liquid extract, standardised (1875)

Ipecacuanha, prepared (0093)

Ipecacuanha root (0094)

Ipecacuanha tincture, standardised (1530)

Mandarin epicarp and mesocarp (2430)

Matricaria flower (0404)

Homoeopathic preparations

Cuprum metallicum for homoeopathic preparations (1610)

Monographs

Amlodipine besilate (1491)

Atracurium besilate (1970)

Azelastine hydrochloride (1633)

Betahistine mesilate (1071)

Bromocriptine mesilate (0596)

Celecoxib (2591)

Clomipramine hydrochloride (0889)

Dibrompropamidine diisetionate (2300)

Dihydroergocristine mesilate (1416)

Dihydroergotamine mesilate (0551)

Doxycycline hyclate (0272)

Doxycycline monohydrate (0820)

Estradiol valerate (1614)

Fentanyl (1210)

Glyceryl trinitrate solution (1331)

Halothane (0393)

Hexamidine diisetionate (1436)

Human coagulation factor XI (1644)

Hydrocortisone acetate (0334)

Imatinib mesilate (2736)

Ivermectin (1336)

Meropenem trihydrate (2234)

Methylprednisolone (0561)

Methyltestosterone (0410)

Microcrystalline cellulose and carmellose sodium (2050)

Midazolam (0936)

Mitomycin (1655)

Nalidixic acid (0701)

Nimodipine (1245)

Pefloxacin mesilate dihydrate (1460)

Pentamidine diisetionate (1137)

Pergolide mesilate (1555)

Phentolamine mesilate (1138)

Pilocarpine hydrochloride (0633)

Pilocarpine nitrate (0104)

Poly(vinyl alcohol) (1961)

Ramipril (1368)

Ranitidine hydrochloride (0946)

Saccharin sodium (0787)

Saquinavir mesilate (2267)

Sevoflurane (2269)

Sodium laurilsulfate (0098)

Sorbitol (0435)

Sultamicillin tosilate dihydrate (2212)

Tamoxifen citrate (1046)

Trimipramine maleate (0534)

Ziprasidone mesilate trihydrate (2649)

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CORRECTED TEXTS

更正内容

The texts below have been corrected and are republished in their entirety. These corrections are to be taken into account from the publication date of Supplement 8.7 (1 October 2015).

以下内容进行了更正，全文重新发布。这些更正应从8.7增补公布日起考量（2015年10月1日）。

MONOGRAPHS

Herbal drugs and herbal drug preparations

Anemarrhena asphodeloides rhizome (2661)

Nettle root (2538)

Monographs

Sodium acetate trihydrate (0411)

Sodium starch glycolate (type A) (0983)

Sodium starch glycolate (type B) (0984)

HARMONISED TEXTS

协调一致的内容

The texts below have undergone pharmacopoeial harmonisation (see chapter 5.8. Pharmacopoeial harmonisation).

以下内容已经过药典协调一致化评估（参见第5.8章药典协调）。

MONOGRAPHS

Monographs

Hydroxypropylcellulose, low-substituted (2083)

Saccharin sodium (0787)

Sodium laurilsulfate (0098)

TEXTS WHOSE TITLE HAS CHANGED

标题变更的内容

The title of the following text has been changed in Supplement 8.7.

以下内容的标题在8.7增补本中进行了变更。

GENERAL CHAPTERS

2.2.48. Raman spectroscopy (previously Raman spectrometry)

DELETED TEXTS

删除内容

The following text is deleted as of 1 April 2016.

以下内容自2016年4月1日起删除。

MONOGRAPHS

Herbal drugs and herbal drug preparations

Cinnamon tincture (1819)

The following texts are deleted as of 1 January 2016.

以下内容自2016年1月1日起删除。

MONOGRAPHS

Immunosera for veterinary use

Clostridium novyi alpha antitoxin for veterinary use (0339)

Clostridium perfringens beta antitoxin for veterinary use (0340)

Clostridium perfringens epsilon antitoxin for veterinary use (0341)

The following text is deleted as of 1 April 2015.

以下内容自2015年4月1日起删除。

MONOGRAPHS

Herbal drugs and herbal drug preparations

Liquorice ethanolic liquid extract, standardised (1536)