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BP2015英国药典索引
全英文版本,来源网络仅供参考!
顺便介绍下现在最新药典的版本:
◇ 欧洲药典8为欧洲药典最新版本;
◇ 2013年7月出版;
◇ 2014年1月生效。
欧洲药典第8版包括两个基本卷,于2013年7月出版发行,以后在每次欧洲药典委员会全会做出决定后,通过非累积增补本更新,每年出3个增补本。第8版累计共有8个非累积增补本(8.1~8.8)。
各增补版的出版日期及执行的日期。
最初的两卷包括第7版完整的内容,以及欧洲药典委员会在2012年12月全会上通过或修订的内容,共收载了2224个个论,345个含插图或色谱图的总论,以及2500种试剂的说明。变化的内容(插入或删除的内容)在页边标注出
自2014年1月起,在欧洲药典成员国,包括欧盟国家,将执行第8版并取代第7版。第7版至12月31日都是有效的。欧洲药典有英文版与法文版,英语与法语是欧洲委员会的官方语言。欧洲药典有印刷版、USB闪存版和在线版。其西班牙文版正在翻译之中,将来包括在在线版中,不再另收取费用。
欧洲药典: 一部药品与药用物质的标准
欧洲药典是欧洲药品质量控制的标准。已有多项法律文件使欧洲药典成为法定标准:
2009年经36个欧洲国家和欧盟批准的编撰欧洲药典协议;
关于人用或兽用药品的欧盟指令2001/82/EC、2001/83/EC(修正案)和2003/63/EC,维持了欧洲药典对在欧洲上市药品的强制执行性。这些标准规定了药品、生产用原材料与合成用中间体成份的定性、定量和所用的检验项目。所有药品、药用物质生产企业在欧洲销售或使用其产品时,都必须遵循欧洲药典标准。
欧洲药典的内容具有法律约束力,由行政管理或司法部门强制要求符合欧洲药典。成员国的国家当局必须采用欧洲药典,必要时可替代相同物质国家标准中的个论。
欧洲药典的内容包括活性物质、辅料、化学、动物、人或植物来源的药用物质或制品、顺势疗法制剂和顺势疗法原料、抗生素,以及制剂和容器等。
欧洲药典还适用于生物制品、血液和血浆制品、疫苗和放射药品。
欧洲药典8.6内容变更
NEW TEXTS The texts below appear for the first time in the European Pharmacopoeia. They will be implemented on 1 January 2016 at the latest. MONOGRAPHS Radiopharmaceutical preparations and starting materials for radiopharmaceutical preparations Copper tetramibi tetrafluoroborate for radiopharmaceutical
preparations (2547)
Herbal drugs and herbal drug preparations
Anemarrhena asphodeloides rhizome (2661)
Hamamelis bark (2532)
Indigo plant leaf (2727)
Homoeopathic preparations
Belladonna for homoeopathic preparations (2489)
Petroleum rectificatum for homoeopathic preparations (2683)
Staphysagria for homoeopathic preparations (2289) Monographs
Exemestane (2766)
Nicorandil (2332)
Pirfenidone (2856)
Sodium selenite (2740)
Solifenacin succinate (2779)
Somatropin solution for injection (2370) REVISED TEXTS The texts below have been technically revised since their last publication. They will be implemented on 1 January 2016. 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 of ionic concentration using ion-selective electrodes
2.4.29. Composition of fatty acids in oils rich in omega-3 acids
2.5.5. Peroxide value
2.5.32. Water: micro determination
2.9.3. Dissolution test for solid dosage forms
2.9.40. Uniformity of dosage units
4. Reagents (new, revised, corrected)
5.2.4. Cell cultures for the production of veterinary vaccines
5.8. Pharmacopoeial harmonisation
5.22. Names of herbal drugs used in traditional Chinese medicine MONOGRAPHS Vaccines for veterinary use Brucellosis vaccine (live) (Brucella melitensis Rev. 1 strain) for
veterinary use (0793)
Radiopharmaceutical preparations and starting materials
for radiopharmaceutical preparations
Pentetate sodium calcium for radiopharmaceutical
preparations (2353)
Technetium (99mTc) medronate injection (0641)
Herbal drugs and herbal drug preparations
Benzoin, Siam (2158)
Bilberry fruit, dried (1588)
Bilberry fruit, fresh (1602)
Centella (1498)
Fresh bilberry fruit dry extract, refined and standardised (2394)
Ginseng (1523)
Java tea (1229)
Homoeopathic preparations
Methods of preparation of homoeopathic stocks and potentisation (2371)
Monographs
Aluminium phosphate, hydrated (1598)
Amidotrizoic acid dihydrate (0873)
Amiloride hydrochloride dihydrate (0651)
Amlodipine besilate (1491)
Anticoagulant and preservative solutions for 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 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 8.6 (1 July 2015), unless otherwise indicated.
GENERAL CHAPTERS
2.4.22. Composition of fatty acids by gas chromatography
2.5.1. Acid value
2.7.14. Assay of hepatitis A vaccine
2.8.13. Pesticide residues
5.7. Table of physical characteristics of radionuclides mentioned in the European Pharmacopoiea
MONOGRAPHS
Radiopharmaceutical preparations and starting 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 The texts below have undergone pharmacopoeial harmonisation (see chapter 5.8. Pharmacopoeial harmonisation).
GENERAL CHAPTERS
2.2.34. Thermal analysis
2.9.3. Dissolution test for solid dosage forms
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 The titles of the following texts have been changed in Supplement 8.6.
GENERAL CHAPTERS
2.2.4. Approximate pH of solutions (previously Relationship between reaction of solution, approximate pH and colour of certain indicators)
MONOGRAPHS
Monographs
Amiloride hydrochloride dihydrate (0651) (previously Amiloride hydrochloride)
DELETED TEXTS The following texts are deleted as of 1 January 2016.
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.
MONOGRAPHS
Monographs
Liquorice ethanolic liquid extract, standardised (1536)
2016年最新版本美国药典 -USP39
美国药典39 USP39 NF34◇ 美国药典最新版本;
◇ 2015年12月出版;
◇ 2016年5月1日生效;
New and Revised Content in USP 39 – NF 34(2016)Revised General InformationGeneral Notices to USP–NF
Description and Solubility
Reagents Introduction
USP and NF Excipients, Listed By CategoryNew & Revised General Chapters<129> Analytical Procedures for Recombinant Therapeutic Monoclonal Antibodies
<162> Diphtheria Antitoxin Potency Testing for Human Immune Globulins
<411> Folic Acid Assay
<503> Acetic Acid in Peptides
<503.1> Trifluoroacetic Acid (TFA) in Peptides
<580> Vitamin C Assay
<661> Containers—Plastics
<661.1> Plastic Materials of Construction
<661.2> Plastic Packaging Systems for Pharmaceutical Use
<670> Containers—Auxiliary Components
<711> Dissolution
<730> Plasma Spectrochemistry
<751> Metal Particles in Ophthalmic Ointments
<771> Ophthalmic Products—Quality Tests
<790> Visible Particulates in Injections
<855> Nephelometry, Turbidimetry, and Visual Comparison
<914> Viscosity-Pressure Driven Methods
<1059> Excipient Performance
<1251> Weighing on an Analytical Balance
<1661> Evaluation of Plastic Packaging Systems and Their Materials of Construction with Respect to Their User Safety Impact
<1730> Plasma Spectrochemistry—Theory and Practice
<1735> X-Ray Fluorescence Spectrometry —Theory and Practice
<1771> Ophthalmic Products—Performance Tests
<2040> Disintegration and Dissolution of Dietary SupplementsNew & Revised Monographs2-Pyrrolidone
5-Hydroxy-L-Tryptophan
Abiraterone Acetate
Abiraterone Acetate Tablets
Aminolevulinic Acid Hydrochloride
Antazoline Phosphate
Aprepitant
Aprepitant Capsules
Aripiprazole Tablets
Aripiprazole Orally Disintegrating Tablets
Ascorbic Acid Tablets
Astragalus Root
Astragalus Root Dry Extract
Astragalus Root Powder
Atropine Sulfate Ophthalmic Ointment
Bacitracin
Bacitracin Ophthalmic Ointment
Bacitracin Zinc
Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment
Benzocaine Lozenges
Benzocaine Otic Solution
Benzocaine and Menthol Topical Aerosol
Benzyl Ether
Bland Lubricating Ophthalmic Ointment
Borage Seed Oil
Bromelain
Budesonide
Butylated Hydroxyanisole
Calcipotriene
Calcipotriene Ointment
Calcium Gluconate
Calcium Citrate
Calcium Sulfate Dihydrate
Candesartan Cilexetil and Hydrochlorothiazide Tablets
Chenodeoxycholic Acid
Chloramphenicol Ophthalmic Ointment
Chloramphenicol And Polymyxin B Sulfate Ophthalmic Ointment
3-Chloropropane-1,2-Diol
Chlortetracycline Hydrochloride Ophthalmic Ointment
Cholesterol
Chondroitin Sulfate Sodium, Shark
Ciprofloxacin Ophthalmic Ointment
Clotrimazole Vaginal Inserts PF
Clotrimazole Lozenges
Clotrimazole Topical Solution
Cloxacillin Sodium
Cupric Nitrate Hydrate
Cyclobenzaprine Hydrochloride Extended-Release Capsules
Dalteparin Sodium
Desmosterol
Dexamethasone Sodium Phosphate Ophthalmic Ointment
Diclofenac Potassium Tablets
Diclofenac Sodium Delayed-Release Tablets
Diclofenac Sodium Extended-Release Tablets
Dicloxacillin Sodium
Diphenhydramine and Phenylephrine Hydrochlorides Tablets
Diphenhydramine Hydrochloride Capsules
Diphenhydramine Hydrochloride Injection
Diphenhydramine Hydrochloride Oral Solution
0.1 M Edetate Disodium VS
0.05 M Edetate Disodium VS
Enalapril Maleate Tablets
Entecavir
Entecavir Tablets
Ephedrine Sulfate Injection
Epitetracycline Hydrochloride
Erythromycin Ophthalmic Ointment
Eszopiclone
Eszopiclone Tablets
Ethylparaben Sodium
Evening Primrose Oil
Flax Seed Oil
Fluconazole Injection
Fluconazole in Sodium Chloride Injection
Fluorescein Sodium
Fluticasone Propionate and Salmeterol Inhalation Aerosol
Fluticasone Propionate and Salmeterol Inhalation Powder
Formic Acid, 98 Percent
Gentamicin and Prednisolone Acetate Ophthalmic Ointment
Gentamicin Sulfate Ophthalmic Ointment
Pharmaceutical Glaze
Glyceryl Monocaprylate
Glyceryl Monocaprylocaprate
Halcinonide
Halcinonide Cream
Halcinonide Ointment
Hydrocortisone Acetate Ophthalmic Ointment
Idoxuridine Ophthalmic Ointment
Iodixanol
Iohexol
Ketorolac Tromethamine Injection
Ketorolac Tromethamine Tablets
Lathosterol
Lidocaine Hydrochloride
Lithocholic Acid
Loratadine Tablets
Meloxicam
Memantine Hydrochloride
Mesalamine
Methocarbamol Injection
1-Monodecanoyl-Rac-Glycerol
1-Monooctanoyl-Rac-Glycerol
Montelukast Sodium Oral Granules
Montelukast Sodium Tablets
Montelukast Sodium Chewable Tablets
Mycophenolate Sodium
Mycophenolic Acid Delayed-Release Tablets
Neomycin Sulfate Ophthalmic Ointment
Neomycin Sulfate and Dexamethasone Sodium Phosphate Ophthalmic Ointment
Neomycin and Polymyxin B Sulfates Ophthalmic Ointment
Neomycin and Polymyxin B Sulfates and Bacitracin Ophthalmic Ointment
Neomycin and Polymyxin B Sulfates, Bacitracin, and Hydrocortisone Acetate Ophthalmic Ointment
Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment
Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone Ophthalmic Ointment
Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone Acetate Ophthalmic Ointment
Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment
Orphenadrine Citrate Injection
Orphenadrine Citrate Extended-Release Tablets
Oxacillin Sodium
Oxytetracycline Hydrochloride and Polymyxin B Sulfate Ophthalmic Ointment
Paliperidone
Pancuronium Bromide Injection
Phenylephrine Hydrochloride Tablets
Poly (Tetrafluoroethylene)
Polyoxyethylene 10 Lauryl Ether
Polysorbate 80
Potassium Arsenite, Tenth-Normal (0.1 N)
Potassium Permanganate, Tenth-Normal (0.1 N)
Pregnenolone Isobutyrate
Propoxyphene Hydrochloride
Propoxyphene Hydrochloride Capsules
Propoxyphene Hydrochloride and Acetaminophen Tablets
Propoxyphene Hydrochloride, Aspirin, and Caffeine Capsules
Propoxyphene Napsylate
Propoxyphene Napsylate Oral Suspension
Propoxyphene Napsylate Tablets
Propoxyphene Napsylate and Acetaminophen Tablets
Propoxyphene Napsylate and Aspirin Tablets
Pyridostigmine Bromide Tablets
Saccharin Sodium
Salicylamide
Sesame Oil
Silver Nitrate, Tenth-Normal (0.1 N)
Simvastatin Tablets
Sitagliptin Phosphate
Sitagliptin Tablets
Sodium Ammonium Phosphate Tetrahydrate
Sodium Chloride Ophthalmic Ointment
Sodium Lauryl Sulfate
Sodium Salicylate
Sodium Salicylate Tablets
Sodium Stearyl Fumarate
Stearic Acid
Sulfacetamide Sodium Ophthalmic Ointment
Sulfacetamide Sodium and Prednisolone Acetate Ophthalmic Ointment
Sodium Thiosulfate, Tenth-Normal (0.1 N)
Teriparatide
Tetracycline
Tetracycline Hydrochloride
Tetracycline Hydrochloride Capsules
Tetracycline Hydrochloride Ophthalmic Ointment
Thorium Nitrate
Thyroid
Thyroid Tablets
Tobramycin Ophthalmic Ointment
Tobramycin and Dexamethasone Ophthalmic Ointment
Tolcapone
Tolcapone Tablets
Trihexyphenidyl Hydrochloride
Valine
Oil- and Water-Soluble Vitamins Capsules
Oil- and Water-Soluble Vitamins with Minerals Capsules
Oil- and Water-Soluble Vitamins with Minerals Oral Solution
Oil- and Water-Soluble Vitamins with Minerals Tablets
Oil- and Water-Soluble Vitamins Oral Solution
Oil- and Water-Soluble Vitamins Tablets
Water-Soluble Vitamins Capsules
Water-Soluble Vitamins with Minerals Capsules
Water-Soluble Vitamins with Minerals Tablets
Water-Soluble Vitamins Tablets
Zaleplon
New and Revised OtherL8
L10
L11
L20
L65
L78
L88
L92
L93
L94
美国药典39 USP39新增和修订内容:下载后面附件哈
英国药典简介
《英国药典》是英国药品委员会(British Pharmacopoeia Commission)的正式出版物,是英国制药标准的重要来源。英国药典不仅为读者提供了药用和成药配方标准以及公式配药标准,而且也向读者展示了许多明确分类并可参照的欧洲药典专著。
英国药典出版周期:
英国药典出版周期不定,最新的版本为2016版。英国药典2016版共6卷。
英国药典官方网站:http://www.pharmacopoeia.co.uk/
英国药典2016 BP2016◇ 该版本为英国药典最新版本;
◇ 2015年8月出版;
◇ 2016年1月生效;
◇ 印刷版共包含6卷;
◇ 包含欧洲药典8.0-8.5的所有内容;
◇ 新增37个英国药典专论;
◇ 修正专论142个;
◇ 英国药典2016版目录索引[PDF文件370KB]
◇ 兽药版索引[PDF格式,52KB];
◇ ISBN 9780113230006;
美国食品化学法典8 Food Chemicals Codex FCC8最新版本:FCC8
2012年3月出版,2012年6月1日生效。
《食品化学法典》(FCC) 是国际公认的标准各论,用于验证食品成分的纯度及特性。 自 1966 年公布以来,FCC 通过极为严格和透明的科学流程制定、审查了多项标准,并一直敦促食品、食品成分、食品添加剂和加工助剂制造商遵循这些标准。 2006 年,美国药典 (USP) 从美国医学研究院 (Institute of Medicine) 收购了 FCC,力争为后续修订工作和标准的更新提供全力支持。 FCC第六版已于 2008年2月出版。
USP 计划两年出版一次 FCC,在正文发布期间将公布相关的增补内容
美国食品化学法典 FCC 的适用对象 FCC 是从事以下工作者的重要参考材料食品生产食品化学和成分食品质量控制食品监管事务 美国食品化学法典 FCC 的作用 可方便快速地查阅 1100 多种食品级成分的各论标准;包含检验与测试程序的逐步操作指导;节省订定协议和标准操作程序 (SOP) 的时间和花费;帮助遵守监管要求;FCC8 索引文件,PDF格式,24页,9.67MB
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