Deletion of the test for heavy metals for the 9th Edition
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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.
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SUBSTANCES FOR HOMOEOPATHIC PREPARATIONS ˳ÊÆÁÆ·¨Ò©ÓÃÎïÖÊ
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 Ò©ÓÃÎïÖÊ
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-¦Á-Tocopheryl hydrogen succinate (1258)
RRR-¦Á-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)
New reagents published in the European Pharmacopoeia
EP9Àï·¢²¼µÄÐÂÊÔ¼Á
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.
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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.
ÿ¸öÊÔ¼Á¶¼ÓÐÒ»¸öΨһµÄ7λË÷ÒýºÅ£¬ÔÚÊÔ¼ÁÃû³ÆµÄºóÃæÓÃбÌå¸ø³ö¡£´Ë±àºÅÔÚºóÐøÕ½ÚÐÞ¶©Öв»»á¸Ä±ä£¬ÓÃÓÚEDQMʶ±ð£¬EPÓû§Ò²»á·¢ÏÖËüºÜÓÐÓõģ¬ÀýÈçÔÚÊÔ¼Á¿â´æ¹ÜÀíÖС£
Reagents published in 9.0
Chapter 4.1.1. (Reagents)
Geniposide. 1196800.
4¡ä-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¡¢EPµÚ9°æÄÚÈÝ
IV. CONTENTS OF THE 9th EDITION
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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.
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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.
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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.
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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.
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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.
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For the 9th Edition, the following decisions and systematic modifications to the texts of the European Pharmacopoeia have been made.
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¨C Appearance and granulometry have been deleted from the descriptions of silica gels for chromatography in general chapter 4. Reagents.
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Individual copies of texts published in this edition will not be supplied.
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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.
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A list of new reagents published during the course of this edition is available under ¡®Useful information¡¯ in Pharmeuropa Online.
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NEW TEXTS ÐÂÎı¾
The following texts appear for the first time in the European Pharmacopoeia. They will be implemented on 1 January 2017 at the latest.
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GENERAL CHAPTERS ͨÂÛ
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 ¸÷ÂÛ
Vaccines for veterinary use ÊÞÓÃÒßÃç
Infectious bovine rhinotracheitis vaccine (inactivated) (2674)
Herbal drugs and herbal drug preparations ²ÝÒ©ºÍ²ÝÒ©ÖÆÆ·
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 ˳ÊÆÁÆ·¨Ò©Îï
Magnesium fluoratum for homoeopathic preparations (2676)
Monographs ¸÷ÂÛ
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)
Herbal drugs and herbal drug preparations ²ÝÒ©ºÍ²ÝÒ©ÖÆÆ·
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 ˳ÊÆÁÆ·¨Ò©Îï
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 ¸÷ÂÛ
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-¦Á-Tocopheryl hydrogen succinate (1258)
RRR-¦Á-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 ¸üÕý¹ýµÄÎı¾
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).
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GENERAL CHAPTERS ͨÔò
2.2.27. Thin-layer chromatography
MONOGRAPHS ¸÷ÂÛ
Radiopharmaceutical preparations and starting materials for radiopharmaceutical preparations
·ÅÉäÐÔÒ©ÎïÖƼÁ¼°ÆäÆðʼÎïÁÏ
Iobenguane sulfate for radiopharmaceutical preparations (2351)
Homoeopathic preparations ˳ÊÆÁÆ·¨Ò©Îï
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 ¸÷ÂÛ
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 ͳһºóµÄÎı¾
The following texts have undergone pharmacopoeial harmonisation for the 9th Edition (see chapter 5.8. Pharmacopoeial harmonisation).
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MONOGRAPHS ¸÷ÂÛ
Monographs ¸÷ÂÛ
Carmellose (2360)
Cellulose, microcrystalline (0316)
Cellulose, powdered (0315)
Croscarmellose sodium (0985)
Povidone (0685)
TEXTS WHOSE TITLE HAS CHANGED Îı¾±êÌâ¾¹ý±ä¸ü
The titles of the following texts have been changed for the 9th Edition.
MONOGRAPHS ¸÷ÂÛ
Monographs ¸÷ÂÛ
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)
À´Ô´;Julia
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