EP8.6增补内容

EP8.6增补内容  

2015-05-20

   

CONTENTS OF SUPPLEMENT 8.6

EP8.6增补内容

A vertical line in the margin indicateswhere part of a text has been revised or corrected. A horizontal line in themargin indicates where part of a text has been deleted. However, theseindications, which are not necessarily exhaustive, are given for informationand do not form an official part of the texts. Editorial changes are notindicated.

Individual copies of texts will not besupplied.

Subscribers to the current version(printed or electronic) of the European Pharmacopoeia have access to an archiveversion of all previous editions of the European Pharmacopoeia.

NEW TEXTS 新增内容

The texts below appear for the firsttime in the European Pharmacopoeia. They will be implemented on 1 January 2016 at the latest.

以下内容为首次出现在欧洲药典的内容，最迟于2016年1月1日实施。

MONOGRAPHS

Radiopharmaceutical preparations andstarting materials for radiopharmaceutical preparations

Copper tetramibi tetrafluoroborate forradiopharmaceutical preparations (2547)

Herbal drugs and herbal drugpreparations

Anemarrhena asphodeloides rhizome (2661)

Hamamelis bark (2532)

Indigo plant leaf (2727)

Homoeopathic preparations

Belladonna for homoeopathic preparations(2489)

Petroleum rectificatum for homoeopathicpreparations (2683)

Staphysagria for homoeopathicpreparations (2289)

Monographs

Exemestane (2766)

Nicorandil (2332)

Pirfenidone (2856)

Sodium selenite (2740)

Solifenacin succinate (2779)

Somatropin solution for injection (2370)

REVISED TEXTS 修订内容

The texts below have been technicallyrevised since their last publication. They will be implemented on 1 January 2016.

以下内容自上次公布来进行了技术修订，将于2016年1月1日实施。

GENERAL CHAPTERS

2.2.4. Approximate pH of solutions

2.2.19. Amperometric titration

2.2.20. Potentiometric titration

2.2.34. Thermal analysis

2.2.36. Potentiometric determination ofionic concentration using ion-selective electrodes

2.4.29. Composition of fatty acids inoils rich in omega-3 acids

2.5.5. Peroxide value

2.5.32. Water: micro determination

2.9.3. Dissolution test for solid dosageforms

2.9.40. Uniformity of dosage units

4. Reagents (new, revised, corrected)

5.2.4. Cell cultures for the productionof veterinary vaccines

5.8. Pharmacopoeial harmonisation

5.22. Names of herbal drugs used intraditional Chinese medicine

MONOGRAPHS

Vaccines for veterinary use

Brucellosis vaccine (live) (Brucellamelitensis Rev. 1 strain) for veterinary use (0793)

Radiopharmaceutical preparations andstarting materials for radiopharmaceutical preparations

Pentetate sodium calcium forradiopharmaceutical preparations (2353)

Technetium (99mTc) medronate injection(0641)

Herbal drugs and herbal drugpreparations

Benzoin, Siam (2158)

Bilberry fruit, dried (1588)

Bilberry fruit, fresh (1602)

Centella (1498)

Fresh bilberry fruit dry extract,refined and standardized (2394)

Ginseng (1523)

Java tea (1229)

Homoeopathic preparations

Methods of preparation of homoeopathicstocks and potentisation (2371)

Monographs

Aluminium phosphate, hydrated (1598)

Amidotrizoic acid dihydrate (0873)

Amiloride hydrochloride dihydrate (0651)

Amlodipine besilate (1491)

Anticoagulant and preservative solutionsfor human blood (0209)

Aprotinin (0580)

Aprotinin concentrated solution (0579)

Bromhexine hydrochloride (0706)

Buserelin (1077)

Carbomers (1299)

Carnauba wax (0597)

Chymotrypsin (0476)

Crospovidone (0892)

Demeclocycline hydrochloride (0176)

Dihydralazine sulfate, hydrated (1310)

Diphenhydramine hydrochloride (0023)

Dithranol (1007)

Doxapram hydrochloride (1201)

Filgrastim concentrated solution (2206)

Fluticasone propionate (1750)

Fructose (0188)

Fulvestrant (2443)

Galactose (1215)

Glimepiride (2223)

Glucose, anhydrous (0177)

Glucose monohydrate (0178)

Hexylresorcinol (1437)

Human coagulation factor IX (rDNA)concentrated solution (2522)

Hypromellose (0348)

Iopanoic acid (0700)

Ioxaglic acid (2009)

Isoleucine (0770)

Lactose, anhydrous (1061)

Lactose monohydrate (0187)

Leucine (0771)

Lysine hydrochloride (0930)

Methionine (1027)

Methylcellulose (0345)

Methylprednisolone acetate (0933)

Methylprednisolone hydrogen succinate(1131)

Methylthioninium chloride (1132)

Naftidrofuryl hydrogen oxalate (1594)

Nicotinamide (0047)

Orphenadrine citrate (1759)

Orphenadrine hydrochloride (1760)

Oxeladin hydrogen citrate (1761)

Oxolinic acid (1353)

Pancreas powder (0350)

Phenazone (0421)

Phentolamine mesilate (1138)

Polysorbate 80 (0428)

Potassium hydroxide (0840)

Povidone, iodinated (1142)

Propylene glycol dicaprylocaprate (2122)

Quinidine sulfate (0017)

Quinine hydrochloride (0018)

Quinine sulfate (0019)

Risedronate sodium 2.5-hydrate (2572)

Rivastigmine hydrogen tartrate (2630)

Sodium amidotrizoate (1150)

Sodium hydroxide (0677)

Sodium nitroprusside (0565)

Sodium selenite pentahydrate (1677)

Spirapril hydrochloride monohydrate(1766)

Sucrose (0204)

Sugar spheres (1570)

Sulfacetamide sodium (0107)

Theophylline-ethylenediamine hydrate(0301)

Thiamine hydrochloride (0303)

Thiamine nitrate (0531)

Thiamphenicol (0109)

Tribenoside (1740)

Trypsin (0694)

CORRECTED TEXTS 更正内容

The texts below have been corrected andare republished in their entirety. These corrections are to be taken intoaccount from the publication date of Supplement 8.6 (1 July 2015),unless otherwise indicated.

以下内容进行了更正，其更正内容将自增补8.6公布开始日实施（2015年7月1日），另有说明者除外。

GENERAL CHAPTERS

2.4.22. Composition of fatty acids bygas chromatography

2.5.1. Acid value

2.7.14. Assay of hepatitis A vaccine

2.8.13. Pesticide residues

5.7. Table of physical characteristicsof radionuclides mentioned in the European Pharmacopoiea

MONOGRAPHS

Radiopharmaceutical preparations andstarting materials for radiopharmaceutical preparations

Gallium (68Ga) edotreotide injection(2482)

Monographs

Cimetidine (0756)

Cimetidine hydrochloride (1500)

Flucytosine (0766)

Goserelin (1636)

Human antithrombin III concentrate(0878)(1)

Insulin, bovine (1637)

Insulin, human (0838)

Insulin, porcine (1638)

Insulin preparations, injectable (0854)

Isomalt (1531)

Miconazole nitrate (0513)

Nitric acid (1549)

Oxaliplatin (2017)

Polyoxypropylene stearyl ether (2602)

HARMONISED TEXTS 协调一致性内容

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

以下内容已经通过了药典协调一致性评估（参见第5.8章药典协调）。

GENERAL CHAPTERS

2.2.34. Thermal analysis

2.9.3. Dissolution test for solid dosageforms

2.9.40. Uniformity of dosage units

MONOGRAPHS

Monographs

Crospovidone (0892)

Glucose, anhydrous (0177)

Glucose monohydrate (0178)

Hypromellose (0348)

Methylcellulose (0345)

Polysorbate 80 (0428)

TEXTS WHOSE TITLE HAS CHANGED 标题变更的内容

The titles of the following texts havebeen changed in Supplement 8.6.

以下内容的标题自8.6增补开始变更。

GENERAL CHAPTERS

2.2.4. Approximate pH of solutions (previously Relationship betweenreaction of solution, approximate pH and colour of certain indicators)

MONOGRAPHS

Monographs

Amiloride hydrochloride dihydrate (0651) (previously Amiloride hydrochloride)

DELETED TEXTS 删除内容

The following texts are deleted as of 1 January 2016.

以下内容自2016年开始删除。

MONOGRAPHS

Immunosera for veterinary use

Clostridium novyi alpha antitoxin forveterinary use (0339)

Clostridium perfringens beta antitoxinfor veterinary use (0340)

Clostridium perfringens epsilonantitoxin for veterinary use (0341)

The following text is deleted as of 1 April 2015.

以下内容自2015年4月1日开始删除。

MONOGRAPHS

Monographs

Liquorice ethanolic liquid extract,standardised (1536)

http://zhuyujiao1972.blog.163.com/blog/static/98694727201542024238216/

看看！！！！！！！