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EP第9版最新内容整合

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1、EP第9版删除重金属项目  

Deletion of the test for heavy metals for the 9th Edition

EP9版删除重金属项目

As a first step of the Ph. Eur. strategy of implementation of the ICH Q3D guideline for elemental impurities and according to the decision taken at the 151st session of the European Pharmacopoeia Commission (March 2015), the test for heavy metals (2.4.8 and equivalent) will be deleted from all individual monographs on substances for pharmaceutical use (except substances for veterinary use only). Impacted monographs are listed in the table below. These deletions will be implemented for the 9th Edition and will therefore come into force on 1 January 2017.

作为EP实施ICH Q3D元素杂质指南策略的第一步,根据第151次EP委员会会议(2015年3月)的决议,重金属检测项目(2.4.8和等同者)将从所有药用物质各论(除仅供兽用者外)中删除。受影响的各论列在下表中。删除将自EP第9版开始实施,因此自2017年1月1日开始生效。

SUBSTANCES FOR HOMOEOPATHIC PREPARATIONS 顺势疗法药用物质

Ammonium carbonicum for homoeopathic preparations (2916)

Aurum chloratum natronatum for homoeopathic preparations (2141)

Barium chloratum for homoeopathic preparations (2142)

Calcium iodatum for homoeopathic preparations (2144)

Magnesium phosphoricum for homoeopathic preparations (2505)

SUBSTANCES FOR PHARMACEUTICAL USE 药用物质

Abacavir sulfate (2589)

Acamprosate calcium (1585)

Acarbose (2089)

Acebutolol hydrochloride (0871)

Aceclofenac (1281)

Acemetacin (1686)

Acesulfame potassium (1282)

Acetazolamide (0454)

Acetic acid, glacial (0590)

Acetylcholine chloride (1485)

Acetylcysteine (0967)

Acetylsalicylic acid (0309)

N-Acetyltryptophan (1383)

N-Acetyltyrosine (1384)

Acitretin (1385)

Adapalene (2445)

Adenine (0800)

Adipic acid (1586)

Alanine (0752)

Alfadex (1487)

Alginic acid (0591)

Allopurinol (0576)

Almagate (2010)

Alprenolol hydrochloride (0876)

Alum (0006)

Aluminium chloride hexahydrate (0971)

Aluminium hydroxide, hydrated, for adsorption (1664)

Aluminium oxide, hydrated (0311)

Aluminium phosphate gel (2166)

Aluminium phosphate, hydrated (1598)

Aluminium sulfate (0165)

Alverine citrate (2156)

Amantadine hydrochloride (0463)

Ambroxol hydrochloride (1489)

Amidotrizoic acid dihydrate (0873)

4-Aminobenzoic acid (1687)

Aminocaproic acid (0874)

Aminoglutethimide (1291)

Amiodarone hydrochloride (0803)

Amisulpride (1490)

Amitriptyline hydrochloride (0464)

Ammonia solution, concentrated (0877)

Ammonio methacrylate copolymer (type A) (2081)

Ammonio methacrylate copolymer (type B) (2082)

Ammonium bromide (1389)

Ammonium chloride (0007)

Ammonium glycyrrhizate (1772)

Ammonium hydrogen carbonate (1390)

Amoxicillin sodium (0577)

Ampicillin sodium (0578)

Antazoline hydrochloride (0972)

Arginine (0806)

Arginine aspartate (2096)

Arginine hydrochloride (0805)

Articaine hydrochloride (1688)

Ascorbic acid (0253)

Ascorbyl palmitate (0807)

Asparagine monohydrate (2086)

Aspartame (0973)

Aspartic acid (0797)

Atomoxetine hydrochloride (2640)

Atorvastatin calcium trihydrate (2191)

Azithromycin (1649)

Barium sulfate (0010)

Basic butylated methacrylate copolymer (1975)

Benazepril hydrochloride (2388)

Benserazide hydrochloride (1173)

Bentonite (0467)

Benzbromarone (1393)

Benzoic acid (0066)

Betacarotene (1069)

Betadex (1070)

Betahistine mesilate (1071)

Betaxolol hydrochloride (1072)

Bezafibrate (1394)

Bicalutamide (2196)

Biotin (1073)

Biperiden hydrochloride (1074)

Borax (0013)

Boric acid (0001)

Brompheniramine maleate (0977)

Buflomedil hydrochloride (1398)

Bupivacaine hydrochloride (0541)

Butylhydroxyanisole (0880)

Caffeine (0267)

Caffeine monohydrate (0268)

Calcium acetate (2128)

Calcium ascorbate (1182)

Calcium carbonate (0014)

Calcium chloride dihydrate (0015)

Calcium chloride hexahydrate (0707)

Calcium dobesilate monohydrate (1183)

Calcium folinate (0978)

Calcium glucoheptonate (1399)

Calcium gluconate (0172)

Calcium gluconate, anhydrous (2364)

Calcium gluconate for injection (0979)

Calcium glycerophosphate (0980)

Calcium hydrogen phosphate (0981)

Calcium hydrogen phosphate dihydrate (0116)

Calcium hydroxide (1078)

Calcium lactate (2118)

Calcium lactate monohydrate (2117)

Calcium lactate pentahydrate (0468)

Calcium lactate trihydrate (0469)

Calcium levofolinate pentahydrate (1606)

Calcium levulinate dihydrate (1296)

Calcium pantothenate (0470)

Calcium phosphate (1052)

Calcium sulfate dihydrate (0982)

Caprylic acid (1401)

Caprylocaproyl macrogolglycerides (1184)

Captopril (1079)

Carbachol (1971)

Carbamazepine (0543)

Carbasalate calcium (1185)

Carbidopa (0755)

Carbocisteine (0885)

Carbomers (1299)

Carisoprodol (1689)

Carmellose (2360)

Carmellose calcium (0886)

Carmellose sodium (0472)

Carmellose sodium, low-substituted (1186)

Carvedilol (1745)

Cefaclor (0986)

Cefamandole nafate (1402)

Cefoperazone sodium (1404)

Cefprozil monohydrate (2342)

Ceftazidime pentahydrate (1405)

Celecoxib (2591)

Cellulose acetate (0887)

Cellulose acetate butyrate (1406)

Cellulose acetate phthalate (0314)

Cellulose, microcrystalline (0316)

Cellulose, powdered (0315)

Cetostearyl isononanoate (1085)

Chenodeoxycholic acid (1189)

Chitosan hydrochloride (1774)

Chloral hydrate (0265)

Chloroquine phosphate (0544)

Chloroquine sulfate (0545)

Chlorphenamine maleate (0386)

Chlorpromazine hydrochloride (0475)

Chlorpropamide (1087)

Chlorprothixene hydrochloride (0815)

Chlortetracycline hydrochloride (0173)

Cholesterol for parenteral use (2397)

Chondroitin sulfate sodium (2064)

Ciclesonide (2703)

Ciclopirox (1407)

Ciclopirox olamine (1302)

Ciclosporin (0994)

Cilastatin sodium (1408)

Cimetidine (0756)

Cimetidine hydrochloride (1500)

Cinchocaine hydrochloride (1088)

Cinnarizine (0816)

Ciprofloxacin (1089)

Ciprofloxacin hydrochloride (0888)

Citalopram hydrobromide (2288)

Citalopram hydrochloride (2203)

Citric acid (0455)

Citric acid monohydrate (0456)

Clarithromycin (1651)

Clebopride malate (1303)

Clodronate disodium tetrahydrate (1777)

Clofazimine (2054)

Clomipramine hydrochloride (0889)

Clopamide (1747)

Clopidogrel hydrogen sulfate (2531)

Clozapine (1191)

Colestyramine (1775)

Copovidone (0891)

Croscarmellose sodium (0985)

Crospovidone (0892)

Cyclophosphamide (0711)

Cysteine hydrochloride monohydrate (0895)

Cystine (0998)

Deferoxamine mesilate (0896)

Demeclocycline hydrochloride (0176)

Deptropine citrate (1308)

Desipramine hydrochloride (0481)

Desloratadine (2570)

Dexchlorpheniramine maleate (1196)

Dexpanthenol (0761)

Dextran 1 for injection (1506)

Dextran 40 for injection (0999)

Dextran 60 for injection (1000)

Dextran 70 for injection (1001)

Dextranomer (2238)

Dextrin (1507)

Diazepam (0022)

Diclofenac potassium (1508)

Diclofenac sodium (1002)

Didanosine (2200)

Diethylcarbamazine citrate (0271)

Diltiazem hydrochloride (1004)

Dimethylacetamide (1667)

Dimeticone (0138)

Diosmin (1611)

Dipotassium phosphate (1003)

Diprophylline (0486)

Dirithromycin (1313)

Disodium edetate (0232)

Disodium phosphate dihydrate (0602)

Disodium phosphate dodecahydrate (0118)

Disodium phosphate (1509)

Disopyramide (1006)

Disopyramide phosphate (1005)

Disulfiram (0603)

Dobutamine hydrochloride (1200)

Docetaxel (2593)

Docetaxel trihydrate (2449)

Docusate sodium (1418)

Dodecyl gallate (2078)

Domperidone (1009)

Domperidone maleate (1008)

Dopamine hydrochloride (0664)

Dopexamine dihydrochloride (1748)

Dosulepin hydrochloride (1314)

Doxapram hydrochloride (1201)

Doxepin hydrochloride (1096)

Doxycycline hyclate (0272)

Doxycycline monohydrate (0820)

Droperidol (1010)

Duloxetine hydrochloride (2594)

Edetic acid (1612)

Enalapril maleate (1420)

Enalaprilat dihydrate (1749)

Enoxolone (1511)

Entacapone (2574)

Epinastine hydrochloride (2411)

Esketamine hydrochloride (1742)

Etacrynic acid (0457)

Etamsylate (1204)

Ethacridine lactate monohydrate (1591)

Ethambutol hydrochloride (0553)

Ethionamide (0141)

Ethosuximide (0764)

Ethylcellulose (0822)

Ethylenediamine (0716)

Etidronate disodium (1778)

Etilefrine hydrochloride (1205)

Etodolac (1422)

Etofenamate (1513)

Etoposide (0823)

Famotidine (1012)

Fenbufen (1209)

Fenofibrate (1322)

Ferric chloride hexahydrate (1515)

Ferrous gluconate (0493)

Fexofenadine hydrochloride (2280)

Flavoxate hydrochloride (1692)

Flecainide acetate (1324)

Fluconazole (2287)

Flucytosine (0766)

Fludarabine phosphate (1781)

Flumequine (1517)

Fluorouracil (0611)

Fluoxetine hydrochloride (1104)

Flupentixol dihydrochloride (1693)

Fluphenazine decanoate (1014)

Fluphenazine dihydrochloride (0904)

Fluphenazine enantate (1015)

Flurbiprofen (1519)

Flutamide (1423)

Flutrimazole (1424)

Fluvastatin sodium (2333)

Fluvoxamine maleate (1977)

Foscarnet sodium hexahydrate (1520)

Fosfomycin calcium (1328)

Fosfomycin sodium (1329)

Fosfomycin trometamol (1425)

Fosinopril sodium (1751)

Fulvestrant (2443)

Furosemide (0391)

Gabapentin (2173)

Galantamine hydrobromide (2366)

Ganciclovir (1752)

Gemcitabine hydrochloride (2306)

Gemfibrozil (1694)

Glibenclamide (0718)

Gliclazide (1524)

Glucosamine hydrochloride (2446)

Glucosamine sulfate potassium chloride (2708)

Glucosamine sulfate sodium chloride (2447)

Glucose, liquid (1330)

Glucose, liquid, spray-dried (1525)

Glutamic acid (0750)

Glutathione (1670)

Glycerol (0496)

Glycerol (85 per cent) (0497)

Glycerol formal (1671)

Glycine (0614)

Guaifenesin (0615)

Guanethidine monosulfate (0027)

Halofantrine hydrochloride (1979)

Hard fat (0462)

Heparin calcium (0332)

Heparin sodium (0333)

Heparins, low-molecular-mass (0828)

Heptaminol hydrochloride (1980)

Hexetidine (1221)

Histidine (0911)

Histidine hydrochloride monohydrate (0910)

Hydralazine hydrochloride (0829)

Hydrochloric acid, concentrated (0002)

Hydrochloric acid, dilute (0003)

Hydroxycarbamide (1616)

Hydroxyethylcellulose (0336)

Hydroxypropylbetadex (1804)

Hydroxypropylcellulose (0337)

Hydroxyzine hydrochloride (0916)

Hymecromone (1786)

Hypromellose (0348)

Hypromellose phthalate (0347)

Ibuprofen (0721)

Ifosfamide (1529)

Imipramine hydrochloride (0029)

Indapamide (1108)

Indinavir sulfate (2214)

Indometacin (0092)

Iodixanol (2215)

Iohexol (1114)

Iopamidol (1115)

Iopromide (1753)

Iotrolan (1754)

Ioxaglic acid (2009)

Irbesartan (2465)

Isoleucine (0770)

Isoniazid (0146)

Isotretinoin (1019)

Isoxsuprine hydrochloride (1119)

Ivermectin (1336)

Josamycin (1983)

Kaolin, heavy (0503)

Ketamine hydrochloride (1020)

Ketoconazole (0921)

Ketoprofen (0922)

Ketorolac trometamol (1755)

Labetalol hydrochloride (0923)

Lactic acid (0458)

Lactic acid, (S)- (1771)

Lactobionic acid (1647)

Lactose (1061)

Lactose monohydrate (0187)

Lamivudine (2217)

Lamotrigine (1756)

Lauroyl macrogolglycerides (1231)

Leflunomide (2330)

Leucine (0771)

Levamisole hydrochloride (0726)

Levetiracetam (2535)

Levocarnitine (1339)

Levodopa (0038)

Lidocaine hydrochloride (0227)

Lincomycin hydrochloride (0583)

Linoleoyl macrogolglycerides (1232)

Lithium carbonate (0228)

Lithium citrate (0621)

Lopinavir (2615)

Losartan potassium (2232)

Lovastatin (1538)

Lysine acetate (2114)

Lysine hydrochloride (0930)

Macrogol 20 glycerol monostearate (2044)

Macrogol stearate (1234)

Macrogolglycerol hydroxystearate (1083)

Macrogolglycerol ricinoleate (1082)

Macrogols (1444)

Magaldrate (1539)

Magnesium acetate tetrahydrate (2035)

Magnesium aspartate dihydrate (1445)

Magnesium carbonate, heavy (0043)

Magnesium carbonate, light (0042)

Magnesium chloride 4.5 - hydrate (1341)

Magnesium chloride hexahydrate (0402)

Magnesium citrate (2339)

Magnesium citrate dodecahydrate (2401)

Magnesium citrate nonahydrate (2402)

Magnesium gluconate (2161)

Magnesium glycerophosphate (1446)

Magnesium hydroxide (0039)

Magnesium lactate dihydrate (2160)

Magnesium oxide, heavy (0041)

Magnesium oxide, light (0040)

Magnesium peroxide (1540)

Magnesium pidolate (1619)

Magnesium sulfate heptahydrate (0044)

Magnesium trisilicate (0403)

Maleic acid (0365)

Malic acid (2080)

Maltodextrin (1542)

Manganese gluconate (2162)

Manganese glycerophosphate, hydrated (2163)

Manganese sulfate monohydrate (1543)

Mannitol (0559)

Mefloquine hydrochloride (1241)

Meglumine (2055)

Meloxicam (2373)

Mepivacaine hydrochloride (1242)

Meprobamate (0407)

Mepyramine maleate (0278)

Meropenem trihydrate (2234)

Mesalazine (1699)

Mesna (1674)

Metamizole sodium monohydrate (1346)

Metformin hydrochloride (0931)

Methenamine (1545)

Methionine (1027)

dl-Methionine (0624)

Methotrexate (0560)

Methylcellulose (0345)

Methyldopa (0045)

Methylene chloride (0932)

Methylhydroxyethylcellulose (0346)

Methylphenidate hydrochloride (2235)

N-Methylpyrrolidone (1675)

Metoclopramide (1348)

Metoclopramide hydrochloride (0674)

Metolazone (1757)

Metoprolol succinate (1448)

Metoprolol tartrate (1028)

Metrifonate (1133)

Metronidazole (0675)

Metronidazole benzoate (0934)

Mexiletine hydrochloride (1029)

Minocycline hydrochloride dihydrate (1030)

Minoxidil (0937)

Modafinil (2307)

Molsidomine (1701)

Montelukast sodium (2583)

Mycophenolate mofetil (1700)

Nabumetone (1350)

Nadolol (1789)

Naftidrofuryl hydrogen oxalate (1594)

Nalidixic acid (0701)

Naproxen (0731)

Naproxen sodium (1702)

Nateglinide (2575)

Neohesperidin-dihydrochalcone (1547)

Nevirapine (2255)

Nevirapine hemihydrate (2479)

Nicotinamide (0047)

Nicotinic acid (0459)

Niflumic acid (2115)

Nifuroxazide (1999)

Nikethamide (0233)

Nilutamide (2256)

Nimesulide (1548)

Nitric acid (1549)

Nizatidine (1453)

Nonoxinol 9 (1454)

Norfloxacin (1248)

Nortriptyline hydrochloride (0941)

Nystatin (0517)

Octoxinol 10 (1553)

Octyldodecanol (1136)

Octyl gallate (2057)

Ofloxacin (1455)

Olanzapine (2258)

Oleoyl macrogolglycerides (1249)

Olmesartan medoxomil (2600)

Olsalazine sodium (1457)

Omeprazole sodium (1032)

Orciprenaline sulfate (1033)

Orphenadrine citrate (1759)

Orphenadrine hydrochloride (1760)

Oxolinic acid (1353)

Oxybuprocaine hydrochloride (1251)

Oxybutynin hydrochloride (1354)

Oxytetracycline dihydrate (0199)

Oxytetracycline hydrochloride (0198)

Paclitaxel (1794)

Pamidronate disodium pentahydrate (1779)

Pantoprazole sodium sesquihydrate (2296)

Paracetamol (0049)

Paroxetine hydrochloride (2283)

Paroxetine hydrochloride hemihydrate (2018)

Pefloxacin mesilate dihydrate (1460)

Pemetrexed disodium heptahydrate (2637)

Penbutolol sulfate (1461)

Penicillamine (0566)

Pentamidine diisetionate (1137)

Pentobarbital sodium (0419)

Pentoxifylline (0851)

Phenazone (0421)

Pheniramine maleate (1357)

Phenolphthalein (1584)

Phenylalanine (0782)

Phenylbutazone (0422)

Phenylpropanolamine hydrochloride (0683)

Phenytoin (1253)

Phenytoin sodium (0521)

Phloroglucinol (2301)

Phloroglucinol dihydrate (2302)

Phosphoric acid, concentrated (0004)

Phosphoric acid, dilute (0005)

Phthalylsulfathiazole (0352)

Picotamide monohydrate (1358)

Pindolol (0634)

Pioglitazone hydrochloride (2601)

Pipemidic acid trihydrate (1743)

Piperacillin (1169)

Piperacillin sodium (1168)

Piperazine adipate (0423)

Piperazine citrate (0424)

Piperazine hydrate (0425)

Piracetam (1733)

Piretanide (1556)

Piroxicam (0944)

Pivmecillinam hydrochloride (1359)

Poly(vinyl acetate) (1962)

Poly(vinyl alcohol) (1961)

Polyacrylate dispersion 30 per cent (0733)

Polysorbate 20 (0426)

Polysorbate 40 (1914)

Polysorbate 60 (0427)

Polysorbate 80 (0428)

Potassium acetate (1139)

Potassium bromide (0184)

Potassium carbonate (1557)

Potassium chloride (0185)

Potassium citrate (0400)

Potassium dihydrogen phosphate (0920)

Potassium hydrogen aspartate hemihydrate (2076)

Potassium hydrogen carbonate (1141)

Potassium hydrogen tartrate (1984)

Potassium hydroxide (0840)

Potassium iodide (0186)

Potassium metabisulfite (2075)

Potassium nitrate (1465)

Potassium perchlorate (1987)

Potassium sodium tartrate tetrahydrate (1986)

Potassium sorbate (0618)

Potassium sulfate (1622)

Povidone (0685)

Pramipexole dihydrochloride monohydrate (2416)

Pravastatin sodium (2059)

Prazepam (1466)

Praziquantel (0855)

Prilocaine (1362)

Prilocaine hydrochloride (1363)

Primidone (0584)

Probenecid (0243)

Procainamide hydrochloride (0567)

Procaine hydrochloride (0050)

Proline (0785)

Promethazine hydrochloride (0524)

Propacetamol hydrochloride (1366)

Propafenone hydrochloride (2103)

Propranolol hydrochloride (0568)

Propyl gallate (1039)

Propylene glycol (0430)

Propylthiouracil (0525)

Propyphenazone (0636)

Protamine sulfate (0569)

Proxyphylline (0526)

Pyrantel embonate (1680)

Pyrazinamide (0859)

Pyridostigmine bromide (1255)

Pyridoxine hydrochloride (0245)

Pyrrolidone (2180)

Quetiapine fumarate (2541)

Quinapril hydrochloride (1763)

Raloxifene hydrochloride (2375)

Ranitidine hydrochloride (0946)

Ribavirin (2109)

Riboflavin sodium phosphate (0786)

Rifampicin (0052)

Rifamycin sodium (0432)

Rifaximin (2362)

Risedronate sodium 2.5-hydrate (2572)

Ritonavir (2136)

Rivastigmine (2629)

Rivastigmine hydrogen tartrate (2630)

Rizatriptan benzoate (2585)

Rocuronium bromide (1764)

Ropivacaine hydrochloride monohydrate (2335)

Roxithromycin (1146)

Saccharin (0947)

Saccharin sodium (0787)

Salicylic acid (0366)

Saquinavir mesilate (2267)

Selegiline hydrochloride (1260)

Serine (0788)

Sertraline hydrochloride (1705)

Shellac (1149)

Sildenafil citrate (2270)

Silica, colloidal anhydrous (0434)

Silica, colloidal hydrated (0738)

Silica, dental type (1562)

Silica, hydrophobic colloidal (2208)

Simeticone (1470)

Simvastatin (1563)

Sodium acetate trihydrate (0411)

Sodium alendronate trihydrate (1564)

Sodium alginate (0625)

Sodium amidotrizoate (1150)

Sodium aminosalicylate dihydrate (1993)

Sodium ascorbate (1791)

Sodium benzoate (0123)

Sodium bromide (0190)

Sodium calcium edetate (0231)

Sodium caprylate (1471)

Sodium carbonate decahydrate (0191)

Sodium carbonate monohydrate (0192)

Sodium carbonate (0773)

Sodium chloride (0193)

Sodium citrate (0412)

Sodium cromoglicate (0562)

Sodium cyclamate (0774)

Sodium dihydrogen phosphate dihydrate (0194)

Sodium ethyl parahydroxybenzoate (2134)

Sodium glycerophosphate, hydrated (1995)

Sodium hyaluronate (1472)

Sodium hydrogen carbonate (0195)

Sodium hydroxide (0677)

Sodium iodide (0196)

Sodium lactate solution (1151)

Sodium (S)-lactate solution (2033)

Sodium metabisulfite (0849)

Sodium methyl parahydroxybenzoate (1262)

Sodium molybdate dihydrate (1565)

Sodium nitrite (1996)

Sodium perborate, hydrated (1997)

Sodium phenylbutyrate (2183)

Sodium polystyrene sulfonate (1909)

Sodium propionate (2041)

Sodium propyl parahydroxybenzoate (1263)

Sodium salicylate (0413)

Sodium starch glycolate (type A) (0983)

Sodium starch glycolate (type B) (0984)

Sodium starch glycolate (type C) (1566)

Sodium sulfate (0099)

Sodium sulfate decahydrate (0100)

Sodium sulfite (0775)

Sodium sulfite heptahydrate (0776)

Sodium thiosulfate (0414)

Sodium valproate (0678)

Sorbic acid (0592)

Sorbitan laurate (1040)

Sorbitan oleate (1041)

Sorbitan palmitate (1042)

Sorbitan sesquioleate (1916)

Sorbitan stearate (1043)

Sorbitan trioleate (1044)

Sotalol hydrochloride (2004)

Spiramycin (0293)

Stannous chloride dihydrate (1266)

Starches, hydroxyethyl (1785)

Stearoyl macrogolglycerides (1268)

? Pharmeuropa | Useful information | June 2016 15

Sucralfate (1796)

Sucralose (2368)

Sugar spheres (1570)

Sulbactam sodium (2209)

Sulfacetamide sodium (0107)

Sulfadiazine (0294)

Sulfadimethoxine (2741)

Sulfadimidine (0295)

Sulfadoxine (0740)

Sulfafurazole (0741)

Sulfaguanidine (1476)

Sulfamerazine (0358)

Sulfamethizole (0637)

Sulfamethoxazole (0108)

Sulfanilamide (1571)

Sulfasalazine (0863)

Sulfathiazole (0742)

Sulfinpyrazone (0790)

Sulfuric acid (1572)

Sulindac (0864)

Sulpiride (1045)

Sultamicillin (2211)

Sultamicillin tosilate dihydrate (2212)

Suxibuzone (1574)

Tamsulosin hydrochloride (2131)

Tartaric acid (0460)

Teicoplanin (2358)

Tenoxicam (1156)

Terazosin hydrochloride dihydrate (2021)

Tetracaine hydrochloride (0057)

Tetracycline (0211)

Tetracycline hydrochloride (0210)

Theobromine (0298)

Theophylline (0299)

Theophylline monohydrate (0302)

Theophylline-ethylenediamine (0300)

Theophylline-ethylenediamine hydrate (0301)

Thiamazole (1706)

Thiamine hydrochloride (0303)

Thiamine nitrate (0531)

Thiamphenicol (0109)

Thioridazine (2005)

Thioridazine hydrochloride (0586)

Threonine (1049)

Tiabendazole (0866)

Tiapride hydrochloride (1575)

Tiaprofenic acid (1157)

Ticlopidine hydrochloride (1050)

16 ? Pharmeuropa | Useful information | June 2016

Tilidine hydrochloride hemihydrate (1767)

Tinidazole (1051)

Tiotropium bromide monohydrate (2420)

Titanium dioxide (0150)

Tizanidine hydrochloride (2578)

dl-α-Tocopheryl hydrogen succinate (1258)

RRR-α-Tocopheryl hydrogen succinate (1259)

Tolbutamide (0304)

Torasemide (2132)

Tramadol hydrochloride (1681)

Tranexamic acid (0875)

Trapidil (1576)

Trehalose dihydrate (2297)

Tretinoin (0693)

Tribenoside (1740)

Tributyl acetylcitrate (1770)

Triethyl citrate (1479)

Triflusal (1377)

Triglycerides, medium-chain (0868)

Trimebutine maleate (2182)

Trimethadione (0440)

Trimethoprim (0060)

Trimipramine maleate (0534)

Tri-n-butyl phosphate (1682)

Trolamine (1577)

Trometamol (1053)

Troxerutin (2133)

Tryptophan (1272)

Tyrosine (1161)

Urea (0743)

Ursodeoxycholic acid (1275)

Valaciclovir hydrochloride (1768)

Valaciclovir hydrochloride, hydrated (2751)

Valine (0796)

Valproic acid (1378)

Valsartan (2423)

Vancomycin hydrochloride (1058)

Venlafaxine hydrochloride (2119)

Verapamil hydrochloride (0573)

Vigabatrin (2305)

Voriconazole (2576)

Wool fat, hydrogenated (0969)

Xylose (1278)

Zidovudine (1059)

Zinc gluconate (2164)

Ziprasidone hydrochloride monohydrate (2421)

Zopiclone (1060)

Zuclopenthixol decanoate (1707)



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 楼主| 毛毛 发表于 2016-7-13 12:27:17 | 只看该作者
2、EP9里发布的新试剂  

New reagents published in the European Pharmacopoeia

EP9里发布的新试剂

The reagents below have been added, during the course of the 9th Edition, to the list of reagents published in chapter 4 of the European Pharmacopoeia.

以下试剂在EP第9版里增加到了第4章试剂清单里。

Each reagent has a unique 7-digit reference code which is given in italics after the name of the reagent. This number, which will remain unchanged for a given reagent during subsequent revisions of the chapter, is used for identification purposes by the EDQM, and users of the European Pharmacopoeia may also find it useful, for example in the management of reagent stocks.

每个试剂都有一个唯一的7位索引号,在试剂名称的后面用斜体给出。此编号在后续章节修订中不会改变,用于EDQM识别,EP用户也会发现它很有用的,例如在试剂库存管理中。

Reagents published in 9.0

Chapter 4.1.1. (Reagents)

Geniposide. 1196800.

4′-Hydroxyacetophenone. 1196900.

Ibuprofen. 1197000.

Isorhynchophylline. 1197100.

Kaempferol. 1197200.

Macrogol 4000. 1198000.

Paeoniflorin. 1197300.

Paeonol. 1197400.

Polydatin. 1197500.

Potassium sulfate. 1033100.

Rhein. 1197700.

Rhynchophylline. 1197800.

Silica gel for chromatography, octadecylsilyl, with extended pH range, endcapped.1196700.

Silica gel for chromatography, phenylsilyl, end-capped, base-deactivated.1197900.

Sodium benzenesulfonate. 1196600.

Sodium 1-propanesulfonate. 1197600.

Trometamol. 1094200.

Chapter 4.1.3. (Buffer solutions)

Phosphate buffer solution pH 7.0 R7. 4015700.

3、EP第9版内容

IV. CONTENTS OF THE 9th EDITION

EP第9版内容

The 9th Edition consists of new texts as well as all current texts from the 8th Edition, some of which have been revised or corrected.

第9版包括新的内容,以及所有从第8版更新后的所有现行内容,有一些经过了修订,有些是更正过了。

Lists of the monographs and general chapters that, for the 9th Edition, are new, revised or corrected, have undergone pharmacopoeial harmonisation or have had their titles changed, are given below.

以下列出了在第9版中新增、修订、更正、药典统一后、题目变更的各论和通论。

The version date (for example 01/2017 for a text that is new or revised for the 9th Edition), completed by ‘corrected X.X’ if a corrected version of the text has subsequently been published in Supplement X.X, and the reference number (4 digits for monographs and 5 digits for general chapters) are specified above the title of each monograph and general chapter. The version date, completed by ‘corrected X.X’ if appropriate, makes it possible to identify the successive versions of texts in different editions.

版本日期(例如在第9版中新增的和修订后的为01/2017),如果是在之后的增补X.X中有更正的则显示为“corrected X.X”,索引号(各论为4位,通论为5位)在每个各论和通论中给出。适当时,版本日期有“corrected X.X”字样,就可以辨别出不同版本药典中后续各论版本。

Since the 7th Edition, if a text has not been revised for a new edition, the version date published in the previous edition is retained in order to improve traceability. The volume in which the version was first published is stated in the Knowledge database on the EDQM website.

自第7版起,如果正文内容在新版EP里经过了修订,则之前版本EP里公布的各论版本日期还会保留,以便提高追溯性。首次发布的版本在EDQM官网知识数据库里有声明。

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 only and do not form an official part of the texts. Editorial changes are not indicated.

在页边有一条垂直的线标识的文字部分是经过修订或更正的。在页中的横线则表示这部分文字已被删除。但是这些标记并不一定能标识全部的更新内容,只是供参考,而并不成为文本内容的正式部分。编辑性变更不显示。

Lines in the margin that were present in revised or corrected texts in the previous edition are deleted with each new edition.

在前版本中显示的修订或更正文件的在空白处的标识线将在每次发布新版时删除。

From the 9th Edition, corrections that are indicated by the note ‘corrected X.X’ under the version date are to be taken into account as soon as possible and not later than the end of the month following the month of publication of the volume.

自第9版起,采用版本日期下面的注解“corrected X.X”来显示更正应尽快考虑,不能迟于该增补卷发布的当月底。

From the 9th Edition, a barcode is included at the start of each text, providing a link to further information on the text (e.g. the Knowledge database) for smartphones and tablets with a camera and a barcode reader app.

自第9版起,每份文本的开关有一个条码,给具备相机和条码读取APP的手机提供文件里更多信息的链接(例如,知识数据库)。

For the 9th Edition, the following decisions and systematic modifications to the texts of the European Pharmacopoeia have been made.

对于第9版EP,做出了以下决定和系统性文本修订:

–      Tests for heavy metals have been deleted from the monographs concerned (see under ‘Useful information’ in Pharmeuropa Online).

–      重金属测试从相关各论中删除(参见药典在线帮助信息)

–      ‘Anhydrous’ has been deleted from the title of the monographs concerned (see under ‘Useful information’ in Pharmeuropa Online).

–      “无水”从相关各论中删除(参见药典在线帮助信息)

–      Appearance and granulometry have been deleted from the descriptions of silica gels for chromatography in general chapter 4. Reagents.

–      外观和粒度测试从通则第4章.试剂里色谱用硅胶描述中删除

–      The introduction of the ‘Functionality-related characteristics’ section has been updated according to the Style Guide 2014 in the monographs concerned.

–      将“功能相关特性”部分的介绍根据相关各论里类型指南2014进行了更新

–      All impurities in monographs are now represented individually with complete graphic formulae, where possible.

–      只要可能,各论里的所有杂质现在用图来表示

Individual copies of texts published in this edition will not be supplied.

在本版本EP中公布的单个文件拷贝将不再单独提供。

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.

订购当前EP版本(印刷本或电子)者可以进入所有之前的EP版的在线存档版本。

A list of new reagents published during the course of this edition is available under ‘Useful information’ in Pharmeuropa Online.

在此版本中公布的新试剂清单在药典在线帮助信息下可以找到。

NEW TEXTS 新文本

The following texts appear for the first time in the European Pharmacopoeia. They will be implemented on 1 January 2017 at the latest.

以下文本为EP中首次出现,它们最迟将于201711日生效。

GENERAL CHAPTERS 通论

2.7.35. Immunonephelometry for vaccine component assay

2.8.25. High-performance thin-layer chromatography of herbal drugs and herbal drug preparations

5.2.12. Raw materials of biological origin for the production of cell-based and gene therapy medicinal products

5.2.13. Healthy chicken flocks for the production of inactivated vaccines for veterinary use

MONOGRAPHS 各论

Vaccines for veterinary use 兽用疫苗

Infectious bovine rhinotracheitis vaccine (inactivated) (2674)

Herbal drugs and herbal drug preparations 草药和草药制品

Akebia stem (2472)

Cape jasmine fruit (2565)

Codonopsis root (2714)

Horse-chestnut (1830)

Horse-chestnut dry extract, standardised (1829)

Paeony root, red (2425)

Paeony root, white (2424)

Polygonum cuspidatum rhizome and root (2724)

Polygonum orientale fruit (2726)

Uncaria stem with hooks (2729)

Zanthoxylum bungeanum pericarp (2656)

Homoeopathic preparations 顺势疗法药物

Magnesium fluoratum for homoeopathic preparations (2676)

Monographs 各论

Animal epithelia and outgrowths for allergen products (2621)

Aprepitant (2757)

Clopidogrel besilate (2790)

Clopidogrel hydrochloride (2791)

Escitalopram (2758)

Hydroxychloroquine sulfate (2849)

Hymenoptera venoms for allergen products (2623)

Irinotecan hydrochloride trihydrate (2675)

Mites for allergen products (2625)

Moulds for allergen products (2626)

Pollens for allergen products (2627)

Tacalcitol monohydrate (2272)

Temozolomide (2780)

Teriparatide (2829)

REVISED TEXTS 修订后的文本
The following texts have been technically revised since their last publication. They will be implemented on 1 January 2017.
以下文本自其上次公布后经过了技术性修订,将于201711日起实施。
GENERAL CHAPTERS 通则
2.4.24. Identification and control of residual solvents
2.5.28. Water in gases
2.9.6. Uniformity of content of single-dose preparations
4. Reagents
5.2.3. Cell substrates for the production of vaccines for human use
5.8. Pharmacopoeial harmonisation
MONOGRAPHS 各论
General monographs 通论
Allergen products (1063)
Vaccines for human use (0153)
Vaccines for veterinary use (0062)
Dosage forms 制剂剂型
Powders for cutaneous application (1166)
Tampons, medicated (1155)
Vaccines for veterinary use 兽用疫苗
Aujeszky’s disease vaccine (inactivated) for pigs (0744)
Avian infectious bronchitis vaccine (inactivated) (0959)
Avian infectious bursal disease vaccine (inactivated) (0960)
Avian paramyxovirus 3 vaccine (inactivated) for turkeys (1392)
Bovine leptospirosis vaccine (inactivated) (1939)
Bovine viral diarrhoea vaccine (inactivated) (1952)
Calf coronavirus diarrhoea vaccine (inactivated) (1953)
Calf rotavirus diarrhoea vaccine (inactivated) 1954)
Canine adenovirus vaccine (inactivated) (1298)
Canine leptospirosis vaccine (inactivated) (0447)
Canine parvovirosis vaccine (inactivated) (0795)
Egg drop syndrome ’76 vaccine (inactivated) (1202)
Equine herpesvirus vaccine (inactivated) (1613)
Equine influenza vaccine (inactivated) (0249)
Feline calicivirosis vaccine (inactivated) (1101)
Feline chlamydiosis vaccine (inactivated) (2324)
Feline infectious enteritis (feline panleucopenia) vaccine (inactivated) (0794)
Feline leukaemia vaccine (inactivated) (1321)
Feline viral rhinotracheitis vaccine (inactivated) (1207)
Foot-and-mouth disease (ruminants) vaccine (inactivated) (0063)
Fowl cholera vaccine (inactivated) (1945)
Furunculosis vaccine (inactivated, oil-adjuvanted, injectable) for salmonids (1521)
Infectious chicken anaemia vaccine (live) (2038)
Mannheimia vaccine (inactivated) for cattle (1944)
Mannheimia vaccine (inactivated) for sheep (1946)
Mycoplasma gallisepticum vaccine (inactivated) (1942)
Neonatal piglet colibacillosis vaccine (inactivated) (0962)
Neonatal ruminant colibacillosis vaccine (inactivated) (0961)
Newcastle disease vaccine (inactivated) (0870)
Pasteurella vaccine (inactivated) for sheep (2072)
Porcine enzootic pneumonia vaccine (inactivated) (2448)
Porcine influenza vaccine (inactivated) (0963)
Porcine parvovirosis vaccine (inactivated) (0965)
Rabbit haemorrhagic disease vaccine (inactivated) (2325)
Rabies vaccine (inactivated) for veterinary use (0451)
Salmonella Enteritidis vaccine (inactivated) for chickens (1947)
Salmonella Typhimurium vaccine (inactivated) for chickens (2361)
Swine erysipelas vaccine (inactivated) (0064)
Vibriosis (cold-water) vaccine (inactivated) for salmonids (1580)
Vibriosis vaccine (inactivated) for salmonids (1581)
Yersiniosis vaccine (inactivated) for salmonids (1950)

Herbal drugs and herbal drug preparations 草药和草药制品

Aloes, Cape (0258)

Birch leaf (1174)

Butcher’s broom (1847)

Cascara dry extract, standardised (1844)

Chamomile flower, Roman (0380)

Common selfheal fruit-spike (2439)

Mastic (1876)

St. John’s wort (1438)

St. John’s wort dry extract, quantified (1874)

Homoeopathic preparations 顺势疗法药物

Homoeopathic preparations (1038)

Methods of preparation of homoeopathic stocks and potentisation (2371)

Mother tinctures for homoeopathic preparations (2029)

Pillules for homoeopathic preparations (2153)

Agaricus phalloides for homoeopathic preparations (2290)

Ammonium carbonicum for homoeopathic preparations (2916)

Aurum chloratum natronatum for homoeopathic preparations (2141)

Barium chloratum for homoeopathic preparations (2142)

Calcium iodatum for homoeopathic preparations (2144)

Ignatia for homoeopathic preparations (2513)

Magnesium phosphoricum for homoeopathic preparations (2505)

Nux-vomica for homoeopathic preparations (2514)

Monographs 各论

Abacavir sulfate (2589)

Acamprosate calcium (1585)

Acarbose (2089)

Acebutolol hydrochloride (0871)

Aceclofenac (1281)

Acemetacin (1686)

Acesulfame potassium (1282)

Acetazolamide (0454)

Acetic acid, glacial (0590)

Acetylcholine chloride (1485)

Acetylcysteine (0967)

Acetylsalicylic acid (0309)

N-Acetyltryptophan (1383)

N-Acetyltyrosine (1384)

Acitretin (1385)

Adapalene (2445)

Adenine (0800)

Adipic acid (1586)

Alanine (0752)

Alfadex (1487)

Alginic acid (0591)

Allopurinol (0576)

Almagate (2010)

Alprenolol hydrochloride (0876)

Alum (0006)

Aluminium chloride hexahydrate (0971)

Aluminium hydroxide, hydrated, for adsorption (1664)

Aluminium oxide, hydrated (0311)

Aluminium phosphate gel (2166)

Aluminium phosphate, hydrated (1598)

Aluminium sulfate (0165)

Alverine citrate (2156)

Amantadine hydrochloride (0463)

Ambroxol hydrochloride (1489)

Amidotrizoic acid dihydrate (0873)

4-Aminobenzoic acid (1687)

Aminocaproic acid (0874)

Aminoglutethimide (1291)

Amiodarone hydrochloride (0803)

Amisulpride (1490)

Amitriptyline hydrochloride (0464)

Ammonia solution, concentrated (0877)

Ammonio methacrylate copolymer (type A) (2081)

Ammonio methacrylate copolymer (type B) (2082)

Ammonium bromide (1389)

Ammonium chloride (0007)

Ammonium glycyrrhizate (1772)

Ammonium hydrogen carbonate (1390)

Amoxicillin sodium (0577)

Ampicillin (0167)

Ampicillin sodium (0578)

Antazoline hydrochloride (0972)

Arginine (0806)

Arginine aspartate (2096)

Arginine hydrochloride (0805)

Articaine hydrochloride (1688)

Ascorbic acid (0253)

Ascorbyl palmitate (0807)

Asparagine monohydrate (2086)

Aspartame (0973)

Aspartic acid (0797)

Atomoxetine hydrochloride (2640)

Atorvastatin calcium trihydrate (2191)

Azithromycin (1649)

Barium sulfate (0010)

Basic butylated methacrylate copolymer (1975)

Beclometasone dipropionate (0654)

Benazepril hydrochloride (2388)

Benserazide hydrochloride (1173)

Bentonite (0467)

Benzbromarone (1393)

Benzoic acid (0066)

Betacarotene (1069)

Betadex (1070)

Betahistine mesilate (1071)

Betaxolol hydrochloride (1072)

Bezafibrate (1394)

Bicalutamide (2196)

Biotin (1073)

Biperiden hydrochloride (1074)

Borax (0013)

Boric acid (0001)

Brompheniramine maleate (0977)

Buflomedil hydrochloride (1398)

Bupivacaine hydrochloride (0541)

Butylhydroxyanisole (0880)

Caffeine (0267)

Caffeine monohydrate (0268)

Calcipotriol (2011)

Calcium acetate (2128)

Calcium ascorbate (1182)

Calcium carbonate (0014)

Calcium chloride dihydrate (0015)

Calcium chloride hexahydrate (0707)

Calcium dobesilate monohydrate (1183)

Calcium folinate (0978)

Calcium glucoheptonate (1399)

Calcium gluconate (0172)

Calcium gluconate, anhydrous (2364)

Calcium gluconate for injection (0979)

Calcium glycerophosphate (0980)

Calcium hydrogen phosphate (0981)

Calcium hydrogen phosphate dihydrate (0116)

Calcium hydroxide (1078)

Calcium lactate (2118)

Calcium lactate monohydrate (2117)

Calcium lactate pentahydrate (0468)

Calcium lactate trihydrate (0469)

Calciumlevofolinate pentahydrate (1606)

Calcium levulinate dihydrate (1296)

Calcium pantothenate (0470)

Calcium phosphate (1052)

Calcium sulfate dihydrate (0982)

Caprylic acid (1401)

Caprylocaproyl macrogolglycerides (1184)

Captopril (1079)

Carbachol (1971)

Carbamazepine (0543)

Carbasalate calcium (1185)

Carbidopa (0755)

Carbocisteine (0885)

Carbomers (1299)

Carisoprodol (1689)

Carmellose (2360)

Carmellose calcium (0886)

Carmellose sodium (0472)

Carmellose sodium, low-substituted (1186)

Carvedilol (1745)

Cefaclor (0986)

Cefamandole nafate (1402)

Cefoperazone sodium (1404)

Cefprozil monohydrate (2342)

Ceftazidime pentahydrate (1405)

Celecoxib (2591)

Cellulose acetate (0887)

Cellulose acetate butyrate (1406)

Cellulose acetate phthalate (0314)

Cellulose, microcrystalline (0316)

Cellulose, powdered (0315)

Cetostearyl isononanoate (1085)

Chenodeoxycholic acid (1189)

Chitosan hydrochloride (1774)

Chloral hydrate (0265)

Chlorobutanol (0382)

Chloroquine phosphate (0544)

Chloroquine sulfate (0545)

Chlorphenamine maleate (0386)

Chlorpromazine hydrochloride (0475)

Chlorpropamide (1087)

Chlorprothixene hydrochloride (0815)

Chlortetracycline hydrochloride (0173)

Cholecalciferol concentrate (powder form) (0574)

Cholecalciferol concentrate (water-dispersible form) (0598)

Cholesterol for parenteral use (2397)

Chondroitin sulfate sodium (2064)

Ciclesonide (2703)

Ciclopirox (1407)

Ciclopirox olamine (1302)

Ciclosporin (0994)

Cilastatin sodium (1408)

Cimetidine (0756)

Cimetidine hydrochloride (1500)

Cinchocaine hydrochloride (1088)

Cinnarizine (0816)

Ciprofloxacin (1089)

Ciprofloxacin hydrochloride (0888)

Citalopram hydrobromide (2288)

Citalopram hydrochloride (2203)

Citric acid (0455)

Citric acid monohydrate (0456)

Clarithromycin (1651)

Clebopride malate (1303)

Clodronate disodium tetrahydrate (1777)

Clofazimine (2054)

Clomipramine hydrochloride (0889)

Clopamide (1747)

Clopidogrel hydrogen sulfate (2531)

Clozapine (1191)

Colestyramine (1775)

Copovidone (0891)

Copper sulfate (0893)

Croscarmellose sodium (0985)

Crospovidone (0892)

Cyclophosphamide (0711)

Cysteine hydrochloride monohydrate (0895)

Cystine (0998)

Deferoxamine mesilate (0896)

Demeclocycline hydrochloride (0176)

Deptropine citrate (1308)

Desipramine hydrochloride (0481)

Desloratadine (2570)

Dexamethasone acetate (0548)

Dexchlorpheniramine maleate (1196)

Dexpanthenol (0761)

Dextran 1 for injection (1506)

Dextran 40 for injection (0999)

Dextran 60 for injection (1000)

Dextran 70 for injection (1001)

Dextranomer (2238)

Dextrin (1507)

Diazepam (0022)

Diclofenac potassium (1508)

Diclofenac sodium (1002)

Didanosine (2200)

Diethylcarbamazine citrate (0271)

Diltiazem hydrochloride (1004)

Dimethyl sulfoxide (0763)

Dimethylacetamide (1667)

Dimeticone (0138)

Diosmin (1611)

Dipotassium phosphate (1003)

Diprophylline (0486)

Dirithromycin (1313)

Disodium edetate (0232)

Disodium phosphate (1509)

Disodium phosphate dihydrate (0602)

Disodium phosphate dodecahydrate (0118)

Disopyramide (1006)

Disopyramide phosphate (1005)

Disulfiram (0603)

Dobutamine hydrochloride (1200)

Docetaxel (2593)

Docetaxel trihydrate (2449)

Docusate sodium (1418)

Dodecyl gallate (2078)

Domperidone (1009)

Domperidone maleate (1008)

Dopamine hydrochloride (0664)

Dopexamine dihydrochloride (1748)

Dosulepin hydrochloride (1314)

Doxapram hydrochloride (1201)

Doxepin hydrochloride (1096)

Doxycycline hyclate (0272)

Doxycycline monohydrate (0820)

Droperidol (1010)

Duloxetine hydrochloride (2594)

Dutasteride (2641)

Edetic acid (1612)

Enalapril maleate (1420)

Enalaprilat dihydrate (1749)

Enoxolone (1511)

Entacapone (2574)

Ephedrine (0488)

Epinastine hydrochloride (2411)

Ergocalciferol (0082)

Ergotamine tartrate (0224)

Erythromycin (0179)

Erythromycin estolate (0552)

Erythromycin ethylsuccinate (0274)

Erythromycin lactobionate (1098)

Erythromycin stearate (0490)

Esketamine hydrochloride (1742)

Etacrynic acid (0457)

Etamsylate (1204)

Ethacridine lactate monohydrate (1591)

Ethambutol hydrochloride (0553)

Ethionamide (0141)

Ethosuximide (0764)

Ethylcellulose (0822)

Ethylenediamine (0716)

Etidronate disodium (1778)

Etilefrine hydrochloride (1205)

Etodolac (1422)

Etofenamate (1513)

Etoposide (0823)

Famotidine (1012)

Fenbufen (1209)

Fenofibrate (1322)

Ferric chloride hexahydrate (1515)

Ferrous gluconate (0493)

Fexofenadine hydrochloride (2280)

Flavoxate hydrochloride (1692)

Flecainide acetate (1324)

Fluconazole (2287)

Flucytosine (0766)

Fludarabine phosphate (1781)

Flumequine (1517)

Fluorouracil (0611)

Fluoxetine hydrochloride (1104)

Flupentixol dihydrochloride (1693)

Fluphenazine decanoate (1014)

Fluphenazine dihydrochloride (0904)

Fluphenazine enantate (1015)

Flurbiprofen (1519)

Flutamide (1423)

Flutrimazole (1424)

Fluvastatin sodium (2333)

Fluvoxamine maleate (1977)

Foscarnet sodium hexahydrate (1520)

Fosfomycin calcium (1328)

Fosfomycin sodium (1329)

Fosfomycin trometamol (1425)

Fosinopril sodium (1751)

Fulvestrant (2443)

Furosemide (0391)

Gabapentin (2173)

Galantamine hydrobromide (2366)

Ganciclovir (1752)

Gemcitabine hydrochloride (2306)

Gemfibrozil (1694)

Glibenclamide (0718)

Gliclazide (1524)

Glucosamine hydrochloride (2446)

Glucosamine sulfate potassium chloride (2708)

Glucosamine sulfate sodium chloride (2447)

Glucose (0177)

Glucose, liquid (1330)

Glucose, liquid, spray-dried (1525)

Glutamic acid (0750)

Glutathione (1670)

Glycerol (0496)

Glycerol (85 per cent) (0497)

Glycerol formal (1671)

Glycerol monolinoleate (1429)

Glycerol mono-oleate (1430)

Glycerol monostearate 40-55 (0495)

Glycine (0614)

Guaifenesin (0615)

Guanethidine monosulfate (0027)

Halofantrine hydrochloride (1979)

Heparin calcium (0332)

Heparin sodium (0333)

Heparins, low-molecular-mass (0828)

Heptaminol hydrochloride (1980)

Hexetidine (1221)

Histidine (0911)

Histidine hydrochloride monohydrate (0910)

Hydralazine hydrochloride (0829)

Hydrochloric acid, concentrated (0002)

Hydrochloric acid, dilute (0003)

Hydroxycarbamide (1616)

Hydroxyethylcellulose (0336)

Hydroxypropylbetadex (1804)

Hydroxypropylcellulose (0337)

Hydroxyzine hydrochloride (0916)

Hymecromone (1786)

Hypromellose (0348)

Hypromellose phthalate (0347)

Ibuprofen (0721)

Ifosfamide (1529)

Imipramine hydrochloride (0029)

Indapamide (1108)

Indinavir sulfate (2214)

Indometacin (0092)

Iodixanol (2215)

Iohexol (1114)

Iopamidol (1115)

Iopromide (1753)

Iotrolan (1754)

Ioxaglic acid (2009)

Irbesartan (2465)

Isoleucine (0770)

Isoniazid (0146)

Isotretinoin (1019)

Isoxsuprine hydrochloride (1119)

Ivermectin (1336)

Josamycin (1983)

Kaolin, heavy (0503)

Ketamine hydrochloride (1020)

Ketoconazole (0921)

Ketoprofen (0922)

Ketorolac trometamol (1755)

Labetalol hydrochloride (0923)

Lactic acid (0458)

(S)-Lactic acid (1771)

Lactobionic acid (1647)

Lactose (1061)

Lactose monohydrate (0187)

Lamivudine (2217)

Lamotrigine (1756)

Lauroyl macrogolglycerides (1231)

Leflunomide (2330)

Leucine (0771)

Levamisole hydrochloride (0726)

Levetiracetam (2535)

Levocarnitine (1339)

Levodopa (0038)

Lidocaine hydrochloride (0227)

Lincomycin hydrochloride (0583)

Linoleoyl macrogolglycerides (1232)

Lithium carbonate (0228)

Lithium citrate (0621)

Lopinavir (2615)

Losartan potassium (2232)

Lovastatin (1538)

Lufenuron for veterinary use (2177)

Lysine acetate (2114)

Lysine hydrochloride (0930)

Macrogol 20 glycerol monostearate (2044)

Macrogol stearate (1234)

Macrogolglycerol hydroxystearate (1083)

Macrogolglycerol ricinoleate (1082)

Macrogols (1444)

Magaldrate (1539)

Magnesium acetate tetrahydrate (2035)

Magnesium aspartate dihydrate (1445)

Magnesium carbonate, heavy (0043)

Magnesium carbonate, light (0042)

Magnesium chloride 4.5-hydrate (1341)

Magnesium chloride hexahydrate (0402)

Magnesium citrate (2339)

Magnesium citrate dodecahydrate (2401)

Magnesium citrate nonahydrate (2402)

Magnesium gluconate (2161)

Magnesium glycerophosphate (1446)

Magnesium hydroxide (0039)

Magnesium lactate dihydrate (2160)

Magnesium oxide, heavy (0041)

Magnesium oxide, light (0040)

Magnesium peroxide (1540)

Magnesium pidolate (1619)

Magnesium sulfate heptahydrate (0044)

Magnesium trisilicate (0403)

Maleic acid (0365)

Malic acid (2080)

Maltodextrin (1542)

Manganese gluconate (2162)

Manganese glycerophosphate, hydrated (2163)

Manganese sulfate monohydrate (1543)

Mannitol (0559)

Mefloquine hydrochloride (1241)

Meglumine (2055)

Meloxicam (2373)

Mepivacaine hydrochloride (1242)

Meprobamate (0407)

Mepyramine maleate (0278)

Meropenem trihydrate (2234)

Mesalazine (1699)

Mesna (1674)

Metamizole sodium monohydrate (1346)

Metformin hydrochloride (0931)

Methenamine (1545)

Methionine (1027)

DL-Methionine (0624)

Methotrexate (0560)

Methylcellulose (0345)


Methyldopa (0045)

Methylene chloride (0932)

Methylhydroxyethylcellulose (0346)

Methylphenidate hydrochloride (2235)

N-Methylpyrrolidone (1675)

Metoclopramide (1348)

Metoclopramide hydrochloride (0674)

Metolazone (1757)

Metoprolol succinate (1448)

Metoprolol tartrate (1028)

Metrifonate (1133)

Metronidazole (0675)

Metronidazole benzoate (0934)

Mexiletine hydrochloride (1029)

Minocycline hydrochloride dihydrate (1030)

Minoxidil (0937)

Modafinil (2307)

Molsidomine (1701)

Montelukast sodium (2583)

Mycophenolate mofetil (1700)

Nabumetone (1350)

Nadolol (1789)

Naftidrofuryl hydrogen oxalate (1594)

Nalidixic acid (0701)

Naproxen (0731)

Naproxen sodium (1702)

Nateglinide (2575)

Neohesperidin-dihydrochalcone (1547)

Nevirapine (2255)

Nevirapine hemihydrate (2479)

Niclosamide (0679)

Nicotinamide (0047)

Nicotinic acid (0459)

Niflumic acid (2115)

Nifuroxazide (1999)

Nikethamide (0233)

Nilutamide (2256)

Nimesulide (1548)

Nitric acid (1549)

Nizatidine (1453)

Nonoxinol 9 (1454)

Norethisterone acetate (0850)

Norfloxacin (1248)

Nortriptyline hydrochloride (0941)

Nystatin (0517)

Octoxinol 10 (1553)

Octyl gallate (2057)

Octyldodecanol (1136)

Ofloxacin (1455)

Olanzapine (2258)

Oleoyl macrogolglycerides (1249)

Olmesartan medoxomil (2600)

Olsalazine sodium (1457)

Omeprazole sodium (1032)

Orciprenaline sulfate (1033)

Orphenadrine citrate (1759)

Orphenadrine hydrochloride (1760)

Oxolinic acid (1353)

Oxybuprocaine hydrochloride (1251)

Oxybutynin hydrochloride (1354)

Oxytetracycline dihydrate (0199)

Oxytetracycline hydrochloride (0198)

Paclitaxel (1794)

Pamidronate disodium pentahydrate (1779)

Pantoprazole sodium sesquihydrate (2296)

Paracetamol (0049)

Paroxetine hydrochloride (2283)

Paroxetine hydrochloride hemihydrate (2018)

Pefloxacin mesilate dihydrate (1460)

Pemetrexed disodium heptahydrate (2637)

Penbutolol sulfate (1461)

Penicillamine (0566)

Pentamidine diisetionate (1137)

Pentobarbital sodium (0419)

Pentoxifylline (0851)

Phenazone (0421)

Pheniramine maleate (1357)

Phenolphthalein (1584)

Phenylalanine (0782)

Phenylbutazone (0422)

Phenylpropanolamine hydrochloride (0683)

Phenytoin (1253)

Phenytoin sodium (0521)

Phloroglucinol (2301)

Phloroglucinol dihydrate (2302)

Phosphoric acid, concentrated (0004)

Phosphoric acid, dilute (0005)

Phthalylsulfathiazole (0352)

Picotamide monohydrate (1358)

Pindolol (0634)

Pioglitazone hydrochloride (2601)

Pipemidic acid trihydrate (1743)

Piperacillin (1169)

Piperacillin sodium (1168)

Piperazine adipate (0423)

Piperazine citrate (0424)

Piperazine hydrate (0425)

Piracetam (1733)

Piretanide (1556)

Piroxicam (0944)

Pivmecillinam hydrochloride (1359)

Polyacrylate dispersion 30 per cent (0733)

Polysorbate 20 (0426)

Polysorbate 40 (1914)

Polysorbate 60 (0427)

Polysorbate 80 (0428)

Poly(vinyl acetate) (1962)

Poly(vinyl alcohol) (1961)

Potassium acetate (1139)

Potassium bromide (0184)

Potassium carbonate (1557)

Potassium chloride (0185)

Potassium citrate (0400)

Potassium dihydrogen phosphate (0920)

Potassium hydrogen aspartate hemihydrate (2076)

Potassium hydrogen carbonate (1141)

Potassium hydrogen tartrate (1984)

Potassium hydroxide (0840)

Potassium iodide (0186)

Potassium metabisulfite (2075)

Potassium nitrate (1465)

Potassium perchlorate (1987)

Potassium sodium tartrate tetrahydrate (1986)

Potassium sorbate (0618)

Potassium sulfate (1622)

Povidone (0685)

Pramipexole dihydrochloride monohydrate (2416)

Pravastatin sodium (2059)

Prazepam (1466)

Praziquantel (0855)

Prilocaine (1362)

Prilocaine hydrochloride (1363)

Primidone (0584)

Probenecid (0243)

Procainamide hydrochloride (0567)

Procaine hydrochloride (0050)

Proline (0785)

Promethazine hydrochloride (0524)

Propacetamol hydrochloride (1366)

Propafenone hydrochloride (2103)

Propranolol hydrochloride (0568)

Propyl gallate (1039)

Propylene glycol (0430)

Propylene glycol monolaurate (1915)

Propylthiouracil (0525)

Propyphenazone (0636)

Protamine sulfate (0569)

Proxyphylline (0526)

Pyrantel embonate (1680)

Pyrazinamide (0859)

Pyridostigmine bromide (1255)

Pyridoxine hydrochloride (0245)

Pyrrolidone (2180)

Quetiapine fumarate (2541)

Quinapril hydrochloride (1763)

Raloxifene hydrochloride (2375)

Ranitidine hydrochloride (0946)

Ribavirin (2109)

Riboflavin sodium phosphate (0786)

Rifampicin (0052)

Rifamycin sodium (0432)

Rifaximin (2362)

Risedronate sodium 2.5-hydrate (2572)

Ritonavir (2136)

Rivastigmine (2629)

Rivastigmine hydrogen tartrate (2630)

Rizatriptan benzoate (2585)

Rocuronium bromide (1764)

Ropivacaine hydrochloride monohydrate (2335)

Rosuvastatin calcium (2631)

Roxithromycin (1146)

Saccharin (0947)

Saccharin sodium (0787)

Salicylic acid (0366)

Saquinavir mesilate (2267)

Selegiline hydrochloride (1260)

Serine (0788)

Sertraline hydrochloride (1705)

Shellac (1149)

Sildenafil citrate (2270)

Silica, colloidal anhydrous (0434)

Silica, colloidal hydrated (0738)

Silica, dental type (1562)

Silica, hydrophobic colloidal (2208)

Simeticone (1470)

Simvastatin (1563)

Sodium acetate trihydrate (0411)

Sodium alendronate trihydrate (1564)

Sodium alginate (0625)

Sodium amidotrizoate (1150)

Sodium aminosalicylate dihydrate (1993)

Sodium ascorbate (1791)

Sodium benzoate (0123)

Sodium bromide (0190)

Sodium calcium edetate (0231)

Sodium caprylate (1471)

Sodium carbonate (0773)

Sodium carbonate decahydrate (0191)

Sodium carbonate monohydrate (0192)

Sodium chloride (0193)

Sodium citrate (0412)

Sodium cromoglicate (0562)

Sodium cyclamate (0774)

Sodium dihydrogen phosphate dihydrate (0194)

Sodium ethyl parahydroxybenzoate (2134)

Sodium glycerophosphate, hydrated (1995)

Sodium hyaluronate (1472)

Sodium hydrogen carbonate (0195)

Sodium hydroxide (0677)

Sodium iodide (0196)

Sodium lactate solution (1151)

Sodium (S)-lactate solution (2033)

Sodium metabisulfite (0849)

Sodium methyl parahydroxybenzoate (1262)

Sodium molybdate dihydrate (1565)

Sodium nitrite (1996)

Sodium perborate, hydrated (1997)

Sodium phenylbutyrate (2183)

Sodium polystyrene sulfonate (1909)

Sodium propionate (2041)

Sodium propyl parahydroxybenzoate (1263)

Sodium salicylate (0413)

Sodium starch glycolate (type A) (0983)

Sodium starch glycolate (type B) (0984)

Sodium starch glycolate (type C) (1566)

Sodium sulfate, anhydrous (0099)

Sodium sulfate decahydrate (0100)

Sodium sulfite (0775)

Sodium sulfite heptahydrate (0776)

Sodium thiosulfate (0414)

Sodium valproate (0678)

Sorbic acid (0592)

Sorbitan laurate (1040)

Sorbitan oleate (1041)

Sorbitan palmitate (1042)

Sorbitan sesquioleate (1916)

Sorbitan stearate (1043)

Sorbitan trioleate (1044)

Sotalol hydrochloride (2004)

Spiramycin (0293)

Stannous chloride dihydrate (1266)

Starches, hydroxyethyl (1785)

Stearoyl macrogolglycerides (1268)

Sucralfate (1796)

Sucralose (2368)

Sucrose monopalmitate (2319)

Sucrose stearate (2318)

Sugar spheres (1570)

Sulbactam sodium (2209)

Sulfacetamide sodium (0107)

Sulfadiazine (0294)

Sulfadimethoxine (2741)

Sulfadimidine (0295)

Sulfadoxine (0740)

Sulfafurazole (0741)

Sulfaguanidine (1476)

Sulfamerazine (0358)

Sulfamethizole (0637)

Sulfamethoxazole (0108)

Sulfanilamide (1571)

Sulfasalazine (0863)

Sulfathiazole (0742)

Sulfinpyrazone (0790)

Sulfuric acid (1572)

Sulindac (0864)

Sulpiride (1045)

Sultamicillin (2211)

Sultamicillin tosilate dihydrate (2212)

Sumatriptan succinate (1573)

Suxibuzone (1574)

Tamsulosin hydrochloride (2131)

Tartaric acid (0460)

Teicoplanin (2358)

Tenoxicam (1156)

Terazosin hydrochloride dihydrate (2021)

Tetracaine hydrochloride (0057)

Tetracycline (0211)

Tetracycline hydrochloride (0210)

Theobromine (0298)

Theophylline (0299)

Theophylline monohydrate (0302)

Theophylline-ethylenediamine (0300)

Theophylline-ethylenediamine hydrate (0301)

Thiamazole (1706)

Thiamine hydrochloride (0303)

Thiamine nitrate (0531)

Thiamphenicol (0109)

Thioridazine (2005)

Thioridazine hydrochloride (0586)

Threonine (1049)

Tiabendazole (0866)

Tiapride hydrochloride (1575)

Tiaprofenic acid (1157)

Ticlopidine hydrochloride (1050)

Tilidine hydrochloride hemihydrate (1767)

Timolol maleate (0572)

Tinidazole (1051)

Tiotropium bromide monohydrate (2420)

Titanium dioxide (0150)

Tizanidine hydrochloride (2578)

DL-α-Tocopheryl hydrogen succinate (1258)

RRR-α-Tocopheryl hydrogen succinate (1259)

Tolbutamide (0304)

Torasemide (2132)

Tramadol hydrochloride (1681)

Tranexamic acid (0875)

Trapidil (1576)

Trehalose dihydrate (2297)

Tretinoin (0693)

Triamcinolone hexacetonide (0867)

Tribenoside (1740)

Tributyl acetylcitrate (1770)

Tri-n-butyl phosphate (1682)

Triethyl citrate (1479)

Triflusal (1377)

Triglycerides, medium-chain (0868)

Trimebutine maleate (2182)

Trimethadione (0440)

Trimethoprim (0060)

Trimipramine maleate (0534)

Trolamine (1577)

Trometamol (1053)

Troxerutin (2133)

Tryptophan (1272)

Tyrosine (1161)

Urea (0743)

Ursodeoxycholic acid (1275)

Valaciclovir hydrochloride (1768)

Valaciclovir hydrochloride, hydrated (2751)

Valine (0796)

Valproic acid (1378)

Valsartan (2423)

Vancomycin hydrochloride (1058)

Venlafaxine hydrochloride (2119)

Verapamil hydrochloride (0573)

Vigabatrin (2305)

Voriconazole (2576)

Wool fat, hydrogenated (0969)

Xylose (1278)

Zidovudine (1059)

Zinc gluconate (2164)

Ziprasidone hydrochloride monohydrate (2421)

Zopiclone (1060)

Zuclopenthixol decanoate (1707)

CORRECTED TEXTS 更正过的文本

The following texts have been corrected for the 9th Edition and specify ‘corrected 9.0’ above the title. These corrections are to be taken into account as soon as possible and not later than 31 August 2016 (the end of the month following the month of publication of the 9th Edition).

以下文本经过了更正,在标题上标明“corrected 9.0 ”。这些更正应尽快考虑,不得迟于2016831日(第9版发布的当月月底)。

GENERAL CHAPTERS 通则

2.2.27. Thin-layer chromatography

MONOGRAPHS 各论

Radiopharmaceutical preparations and starting materials for radiopharmaceutical preparations

放射性药物制剂及其起始物料

Iobenguane sulfate for radiopharmaceutical preparations (2351)

Homoeopathic preparations 顺势疗法药物

Hedera helix for homoeopathic preparations (2092)

Hydrastis canadensis for homoeopathic preparations (2500)

Hyoscyamus for homoeopathic preparations (2091)

Hypericum for homoeopathic preparations (2028)

Sulfur for homoeopathic preparations (2515)

Monographs 各论

Acacia, spray-dried (0308)

Amorolfine hydrochloride (2756)

Calcium stearate (0882)

Guar (1218)

Guar galactomannan (0908)

Isoflurane (1673)

Mirtazapine (2338)

Poly(vinyl acetate) dispersion 30 per cent (2152)

Selamectin for veterinary use (2268)

Sodium stearyl fumarate (1567)

Starch, pregelatinised (1267)

Stearic acid (1474)

Xanthan gum (1277)

Zinc chloride (0110)

HARMONISED TEXTS 统一后的文本

The following texts have undergone pharmacopoeial harmonisation for the 9th Edition (see chapter 5.8. Pharmacopoeial harmonisation).

以下文本经过了第9版本EP的药典统一。(参见5.8药典统一)

MONOGRAPHS 各论

Monographs 各论

Carmellose (2360)

Cellulose, microcrystalline (0316)

Cellulose, powdered (0315)

Croscarmellose sodium (0985)

Povidone (0685)

TEXTS WHOSE TITLE HAS CHANGED 文本标题经过变更

The titles of the following texts have been changed for the 9th Edition.

MONOGRAPHS 各论

Monographs 各论

Ampicillin (0167) (previously Ampicillin, anhydrous)

Beclometasone dipropionate (0654) (previously Beclometasone dipropionate, anhydrous)

Calcipotriol (2011) (previously Calcipotriol, anhydrous)

Calcium acetate (2128) (previously Calcium acetate, anhydrous)

Calcium hydrogen phosphate (0981) (previously Calcium hydrogen phosphate, anhydrous)

Calcium lactate (2118) (previously Calcium lactate, anhydrous)

Chlorobutanol (0382) (previously Chlorobutanol, anhydrous)

Citric acid (0455) (previously Citric acid, anhydrous)

Copper sulfate (0893) (previously Copper sulfate, anhydrous)

Disodium phosphate (1509) (previously Disodium phosphate, anhydrous)

Docetaxel (2593) (previously Docetaxel, anhydrous)

Ephedrine (0488) (previously Ephedrine, anhydrous)

Glucose (0177) (previously Glucose, anhydrous)

Lactose (1061) (previously Lactose, anhydrous)

Lufenuron for veterinary use (2177) (previously Lufenuron (anhydrous) for veterinary use)

Magnesium citrate (2339) (previously Magnesium citrate, anhydrous)

Nevirapine (2255) (previously Nevirapine, anhydrous)

Niclosamide (0679) (previously Niclosamide, anhydrous)

Paroxetine hydrochloride (2283) (previously Paroxetine hydrochloride, anhydrous)

Phloroglucinol (2301) (previously Phloroglucinol, anhydrous)

Sodium carbonate (0773) (previously Sodium carbonate,anhydrous)

Sodium sulfite (0775) (previously Sodium sulfite, anhydrous)

Theophylline-ethylenediamine (0300) (previously Theophylline-ethylenediamine, anhydrous)

Torasemide (2132) (previously Torasemide, anhydrous)

Valaciclovir hydrochloride (1768) (previously Valaciclovir hydrochloride, anhydrous)

来源;Julia



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