150 9.01 Reference Standards / General Tests JP XVI Cisplatin RS 9. Reference Standards; Clobetasol Propionate RS Clofibrate RS Standard Solutions; Reagents, Clomifene Citrate RS Cortisone Acetate RS Test Solutions; Measuring Cyanocobalamin RS Instruments, Appliances, etc. Danazol RS Deferoxamine Mesilate RS Deslanoside RS Dexamethasone RS Reference Standards Diclofenamide RS Diethylcarbamazine Citrate RS Diflucortolone Valerate RS 9.01 Reference Standards Digitoxin RS Digoxin RS Reference Standards are the reference substances prepared Dihydroergotoxine Mesilate RS to a specified quality necessary with regard to their intended Dobutamine Hydrochloride RS use as prescribed in monographs of the Pharmacopoeia. Donepezil Hydrochloride RS The Japanese Pharmacopoeia Reference Standards are as Doxazosin Mesilate RS follows: Edrophonium Chloride RS (1) The reference standards which are prepared by those who Elcatonin RS have been registered to prepare them by the Minister of Enalapril Maleate RS Health, Labour and Welfare, according to the Ministerial Endotoxin RS ordinance established by the Minister separately. Epitiostanol RS Aceglutamide RS Ergocalciferol RS Acetaminophen RS Ergometrine Maleate RS Aciclovir RS Estradiol Benzoate RS Adrenaline Bitartrate RS Estriol RS Alendronate Sodium RS Ethenzamide RS Alprostadil RS Ethinylestradiol RS p-Aminobenzoyl Glutamic Acid RS Ethyl Aminobenzoate RS Amitriptyline Hydrochloride RS Ethyl Icosapentate RS Amlexanox RS Etoposide RS Amlodipine Besilate RS Fexofenadine Hydrochloride RS Anhydrous Lactose RS Fludrocortisone Acetate RS Ascorbic Acid RS Fluocinolone Acetonide RS Aspirin RS Fluocinonide RS Atorvastatin Calcium RS Fluorometholone RS Atropine Sulfate RS Fluoxymesterone RS Azathioprine RS Flutamide RS Baclofen RS Fluvoxamine Maleate RS Baicalin RS Folic Acid RS Beclometasone Dipropionate RS Furosemide RS Berberine Chloride RS Fursultiamine Hydrochloride RS Betamethasone RS Gabexate Mesilate RS Betamethasone Sodium Phosphate RS Gefarnate RS Betamethasone Valerate RS Ginsenoside Rb1 RS Bisacodyl RS Ginsenoside Rg1 RS Caffeine RS Gitoxin RS Calcitonin (Salmon) RS Glimepiride RS Calcium Folinate RS D-Glucuronolactone RS Calcium Oxalate Monohydrate RS Glycyrrhizinic Acid RS Camostat Mesilate RS Gonadorelin Acetate RS d-Camphor RS Guaifenesin RS dl-Camphor RS Heparin Sodium RS Carbidopa RS Heparin Sodium for Physical and Chemical Test RS Cellacefate RS High-molecular Mass Urokinase RS Chlordiazepoxide RS Human Chorionic Gonadotrophin RS Chlormadinone Acetate RS Human Insulin RS Chlorpheniramine Maleate RS Human Menopausal Gonadotrophin RS Cholecalciferol RS Hydrochlorothiazide RS Ciclosporin RS Hydrocortisone RS Cilostazol RS Hydrocortisone Acetate RS JP XVI General Tests / 9.01 Reference Standards 151 Hydrocortisone Sodium Phosphate RS Primidone RS Hydrocortisone Succinate RS Probenecid RS Idoxuridine RS Probucol RS Imipramine Hydrochloride RS Prochlorperazine Maleate RS Indapamide RS Progesterone RS Indomethacin RS Propiverine Hydrochloride RS Interleukin-2 RS Protamine Sulfate RS Ipriflavone RS Puerarin RS Isoflurane RS Pyridoxine Hydrochloride RS Kallidinogenase RS Rabeprazole Sodium RS Lactose RS Ranitidine Hydrochloride RS Lactulose RS Reserpine RS Lanatoside C RS Retinol Acetate RS Limaprost RS Retinol Palmitate RS Losartan Potassium RS Riboflavin RS Low-molecular Mass Heparin RS Risedronic Acid RS Loxoprofen RS Ritodrine Hydrochloride RS Lysozyme RS Roxatidine Acetate Hydrochloride RS Maltose RS Saccharated Pepsin RS Manidipine Hydrochloride RS Sarpogrelate Hydrochloride RS Mecobalamin RS Scopolamine Hydrobromide RS Melting Point Standard-Acetanilide RS Sennoside A RS Melting Point Standard-Acetophenetidine RS Sennoside B RS Melting Point Standard-Caffeine RS Serum Gonadotrophin RS Melting Point Standard-Sulfanilamide RS Sevoflurane RS Melting Point Standard-Sulfapyridine RS Simvastatin RS Melting Point Standard-Vanillin RS Spironolactone RS Menatetrenone RS Sulfadiazine Silver RS Mestranol RS Swertiamarin RS Methotrexate RS Tacrolimus RS Methoxsalen RS Teprenone RS Methyldopa RS Testosterone Propionate RS Methylergometrine Maleate RS Thiamine Chloride Hydrochloride RS Methylprednisolone Succinate RS Thiamylal RS Methyltestosterone RS Thrombin RS Metildigoxin RS Tocopherol RS Mexiletine Hydrochloride RS Tocopherol Acetate RS Mizoribine RS Tocopherol Nicotinate RS Nabumetone RS Tocopherol Succinate RS Nateglinide RS Tolazamide RS Neostigmine Methylsulfate RS Tolbutamide RS Nicotinamide RS Tolnaftate RS Nicotinic Acid RS Tosufloxacin Tosilate RS Nilvadipine RS Tranexamic Acid RS Nizatidine RS Trehalose RS Noradrenaline Bitartrate RS Triamcinolone RS Norgestrel RS Triamcinolone Acetonide RS Over-sulfated Chondroitin Sulfate RS Trichlormethiazide RS Oxytocin RS Trihexyphenidyl Hydrochloride RS Ozagrel Sodium RS Troxipide RS Paeoniflorin RS Tyrosine RS Pentobarbital RS Ubidecarenone RS Pemirolast Potassium RS Ulinastatin RS Perphenazine RS Vasopressin RS Phytonadione RS Vinblastine Sulfate RS Pioglitazone Hydrochloride RS Vincristine Sulfate RS Potassium Sucrose Octasulfate RS Warfarin Potassium RS Povidone RS Zidovudine RS Pravastatin 1,1,3,3-tetramethylbutylammonium RS Prazosin Hydrochloride RS (2) The reference standards which are prepared by National Prednisolone RS Institute of Infectious Diseases. Prednisolone Acetate RS Aclarubicin RS Prednisolone Succinate RS 152 9.01 Reference Standards / General Tests JP XVI Actinomycin D RS Diethanolammonium Fusidate RS Amikacin Sulfate RS Doxorubicin Hydrochloride RS Amoxicillin RS Doxycycline Hydrochloride RS Amphotericin B RS Enviomycin Sulfate RS Ampicillin RS Epirubicin Hydrochloride RS Arbekacin Sulfate RS Erythromycin RS Aspoxicillin RS Faropenem Sodium RS Azithromycin RS Flomoxef Triethylammonium RS Aztreonam RS Fosfomycin Phenethylammonium RS Bacampicillin Hydrochloride RS Fradiomycin Sulfate RS Bacitracin RS Gentamicin Sulfate RS Bekanamycin Sulfate RS Gramicidin RS Benzylpenicillin Potassium RS Griseofulvin RS Bleomycin A2 Hydrochloride RS Idarubicin Hydrochloride RS Carumonam Sodium RS Imipenem RS Cefaclor RS Isepamicin Sulfate RS Cefadroxil RS Josamycin RS Cefalexin RS Josamycin Propionate RS Cefalotin Sodium RS Kanamycin Monosulfate RS Cefatrizine Propylene Glycolate RS Latamoxef Ammonium RS Cefazolin RS Lenampicillin Hydrochloride RS Cefbuperazone RS Leucomycin A5 RS Cefcapene Pivoxil Hydrochloride RS Lincomycin Hydrochloride RS Cefdinir RS Lithium Clavulanate RS Cefditoren Pivoxil RS Meropenem RS Cefepime Dihydrochloride RS Micronomicin Sulfate RS Cefixime RS Midecamycin RS Cefmenoxime Hydrochloride RS Midecamycin Acetate RS Cefmetazole RS Minocycline Hydrochloride RS Cefminox Sodium RS Mitomycin C RS Cefodizime Sodium RS Mupirocin Lithium RS Cefoperazone RS Nystatin RS Cefotaxime RS Oxytetracycline Hydrochloride RS Cefotetan RS Panipenem RS Cefotiam Hexetil Hydrochloride RS Peplomycin Sulfate RS Cefotiam Hydrochloride RS Phenethicillin Potassium RS Cefozopran Hydrochloride RS Pimaricin RS Cefpiramide RS Piperacillin RS Cefpirome Sulfate RS Pirarubicin RS Cefpodoxime Proxetil RS Pivmecillinam Hydrochloride RS Cefroxadine RS Polymixin B Sulfate RS Cefsulodin Sodium RS Pyrrolnitrin RS Ceftazidime RS Ribostamycin Sulfate RS Cefteram Pivoxil Mesitylene Sulfonate RS Rifampicin RS Ceftibuten Hydrochloride RS Rokitamycin RS Ceftizoxime RS Roxithromycin RS Ceftriaxone Sodium RS Siccanin RS Cefuroxime Axetil RS Spectinomycin Hydrochloride RS Chloramphenicol RS Spiramycin Acetate II RS Chloramphenicol Palmitate RS Streptomycin Sulfate RS Chloramphenicol Succinate RS Sulbactam RS Ciclacillin RS Sulbenicillin Sodium RS Clarithromycin RS Sultamicillin Tosilate RS Clindamycin Hydrochloride RS Talampicillin Hydrochloride RS Clindamycin Phosphate RS Tazobactam RS Cloxacillin Sodium RS Teicoplanin RS Colistin Sodium Methanesulfonate RS Tetracycline Hydrochloride RS Colistin Sulfate RS Tobramycin RS Cycloserine RS Trichomycin RS Daunorubicin Hydrochloride RS Vancomycin Hydrochloride RS Demethylchlortetracycline Hydrochloride RS Zinostatin Stimalamer RS Dibekacin Sulfate RS Dicloxacillin Sodium RS JP XVI General Tests / 9.21 Standard Solutions for Volumetric Analysis 153 reagent or the specified substance (g) Standard Solutions m: Mass of the standard reagent or the specified substance taken (g) V: Volume of the prepared standard solution consumed 9.21 Standard Solutions for the titration (mL) n: Arithmetical mole number of the specified molar con- for Volumetric Analysis centration of the standard solution to be standardized (e.g. n ＝ 0.02 for 0.02 mol/L standard solution) Standard Solutions for Volumetric Analysis are the solu- tions of reagent with an accurately known concentration, b) Indirect method mainly used for the volumetric analysis. They are prepared When an appropriate standard reagent is not available, to a specified molar concentration. A 1 molar solution is a titrate a defined volume V2 (mL) of a standard solution to be solution which contains exactly 1 mole of a specified sub- standardized with the specified standard solution having a stance in each 1000 mL of the solution and is designated as 1 known factor ( f1), and calculate the factor ( f2) by applying mol/L. If necessary, these solutions are diluted to other spe- the following equation. cified molar concentrations and the diluted solutions are also V1 × f1 used as standard solutions. For example, 0.1 mol/L solution f2 ＝ V is obtained by diluting 1 mol/L solution 10 times by volume. 2 Unless otherwise directed, standard solutions for volumet- f1: Factor of the titrating