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Japanese Pharmacopoeia,日本药典标准物质

Japanese Pharmacopoeia

日本药典标准物质,JPCRS


日本药典 (JP) 是卫生局在听取药事局和食品卫生委员会 (PAFSC) 的意见后制定并出版的,以规范药品的特性和质量。日本药典由一般通告、生药总则、制剂总则、一般试验、工艺和仪器以及官方专论组成。根据药物在医疗实践中的必要性、广泛的应用和使用经验,选择进入日本药典JP 的项目必须是对医疗保健具有重要意义的项目。自 1886 年 6 月首次出版以来,日本药典JP 已定期进行多次修订。日本药典JP第 18版于 2021 年 6 月 7日生效。

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日本制药和医疗器械管理科学学会,Pharmaceutical and Medical Device Regulatory Science Society of Japan (PMRJ)生产并分发以日本药典参考标准为代表的药典标准物质,这些标准物质用于《日本药典》和其他官方纲目规定的试验,通过为保证这些试验的可靠性和客观性提供基础,这有助于确保和改善日本药品和其他产品的质量。

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日本制药和医疗器械监管科学协会(PMRJ)是一个非营利性的普通法人基金会,其目标是推进与药品和医疗器械相关的监管科学。因此,我们打算促进更好的质量,疗效和安全的医疗产品。

   Pharmaceutical and Medical Device Regulatory Science Society of Japan (PMRJ) is a non-profit general incorporated foundation with the objectives of advancing Regulatory Science related to drugs and medical devices. Thus, we intend to promote better quality, efficacy and safety of medical products.

   The main activities which we conduct to meet these objectives are as follows:

Publication of our bimonthly journal, PMDRS (Pharmaceutical and Medical Device Regulatory Science) and documents on pharmaceutical standards, such as Japanese Pharmacopoeia (JP) in English as well as in Japaneseimage.png

Production and distribution of JP Reference Standards for pharmaceuticals

Organizing educational meetings with the purpose of providing cutting-edge information on drugs and medical devices and the venue to exchange different views

Conducting technical editing of proposed draft JP texts under the guidance of the Pharmaceuticals and Medical Devices Agency (PMDA)

Maintenance and distribution of Medical Dictionary for Regulatory Activities, Japanese version (MedDRA/J), an ICH product

Providing research grants related to testing methods and specifications of pharmaceutical drugs in JP

Providing research grants related to promotion of Regulatory Science


Outline of Activities

Publications  =>more

The Japanese Pharmacopoeia 17th ed. (JP17; in English)

Japanese Pharmacopoeial Forum: A quarterly journal (JPF: in Japanese and English)

Pharmaceutical and Medical Device Regulatory Science: A bimonthly journal (mainly in Japanese) (former titles: "IYAKUHIN KENKYU" until March 2004; "Pharmaceutical Regulatory Science" from April 2004 to December 2009)

Japanese Pharmacopoeia Technical Information (JPTI; in Japanese)

The Japanese Pharmaceutical Codex 2002 (JPC2002; in Japanese)

Japanese Orange Books (Approved drug products with therapeutic equivalence evaluations; in Japanese)


Reference Standards   =>more

  The Reference Standards which are used for the tests of drugs and food additives listed in official compendia are established by MHLW (Ministry of Health, Labour and Welfare). We are a registered producer of these Reference Standards. The USP (United States Pharmacopeia) Reference Standards are also available through the Society.Contact : => here

JP Reference Standards and other reference standards

USP Reference Standards


Educational Meetings  =>more

   PMRJ holds Educational Meetings periodically to provide the following information that will enable interested parties to acquire the expertise needed in their line of work.Contact :  to PMRJ

Up-to date information on development, pharmacovigilance (PV), quality control, emerging science and technologies on drugs and medical devices

Development of JP monographs, general test methods and others (biannually)

Results of the latest meetings in ICH


JMO Activities (MedDRA Japanese Maintenance Organization)   =>more
   MedDRA was developed under the auspices of ICH, and is maintained by MSSO (Maintenance and Support Services Organization (https://www.meddra.org/)) and JMO. The responsibilities of the JMO are to maintain and to distribute MedDRA in the Japanese language (MedDRA/J) synchronized with English version, and to promote the standardized utilization in Japan.

Others

Providing research grants related to testing methods and specifications of pharmaceutical drugs in JP

Providing research grants related to promotion of Regulatory Science

日本药典标准物质目录

Pharmaceutical and Medical Device Regulatory Science Society of Japan (PMRJ) Rev. August 16, 2022

PMRJ Reference Standards Catalog

1. Japanese Pharmacopoeia Reference Standards

1005000021 Acetaminophen RS 300 mg ≤25°C A 

1169000021 Acetanilide for Apparatus Suitability RS 200 mg ≤25°C A 

1170000021 Acetophenetidine for Apparatus Suitability RS 200 mg ≤25°C A 

1001500021 Aciclovir RS 100 mg ≤25°C A 

1006000021 Adrenaline Bitartrate for Purity RS 50 mg ≤8°C AU 

1011500021 Alendronate Sodium RS 150 mg ≤25°C A 

1011000021 Alprostadil RS 10 mg ≤5°C R 

1114000021 p-Aminobenzoyl Glutamic Acid for Purity RS 500 mg ≤25°C A 

1008000021 Amitriptyline Hydrochloride RS 100 mg ≤25°C AU 

1012000021 Amlexanox RS 300 mg ≤8°C A 

1010000021 Amlodipine Besilate RS 150 mg ≤25°C A 

7000110021 Ampicillin RS 100 mg −20 – −30°C F 

1106000021 Anhydrous Lactose for Identification RS 50 mg ≤25°C A 

1002000021 Ascorbic Acid RS 1 g ≤25°C A 

1003000021 Aspirin RS 300 mg ≤25°C A 

1005800021 Atorvastatin Calcium RS 150 mg ≤8°C A 

1007000021 Atropine Sulfate RS 250 mg ≤25°C AU 

1034700021 Auranofin RS 100 mg ≤8°C AU 

1001000021 Azathioprine RS 600 mg ≤25°C A 

7000020021 Azithromycin RS 100 mg −20 – −30°C F 

1112000021 Baclofen RS 800 mg ≤8°C AU 

1111000021 Baicalin RS 30 mg ≤8°C A 

1145000021 Beclometasone Dipropionate RS 100 mg ≤25°C A 

1151000021 Berberine Chloride RS 30 mg ≤25°C A 

1146000021 Betamethasone RS 100 mg ≤25°C A 

1148000021 Betamethasone Sodium Phosphate RS 100 mg ≤8°C A 

1147000021 Betamethasone Valerate RS 100 mg ≤25°C A 

1114900021 Bicalutamide RS 100 mg ≤8°C AU 

1115000021 Bisacodyl RS 100 mg ≤25°C A 

1143300021 Bromfenac Sodium RS 150 mg ≤8°C AU 

1114200021 Butyl Parahydroxybenzoate RS 200 mg ≤8°C A 

1036500021 Cabergoline RS 100 mg −20 – −30°C F 

1035000021 Caffeine RS 300 mg ≤25°C AU 

1171000021 Caffeine for Apparatus Suitability RS 200 mg ≤25°C AU 

1039500021 Calcitonin Salmon RS See leaflet ≤−20°C F 

1154000021 Calcium Folinate RS 250 mg ≤25°C A 

1069000021 Calcium Oxalate Monohydrate

for Calibration of Apparatus RS

100 mg ≤25°C A 

1114600021 Calcium Pantothenate RS 1.1 g ≤8°C A 

1037000021 Camostat Mesilate RS 200 mg ≤25°C A 

1042000021 d-Camphor RS 300 mg ≤25°C AU 

1043000021 dl-Camphor RS 300 mg ≤25°C AU 

1040000021 Carbidopa RS 200 mg ≤25°C A 

1040500021 Carboplatin RS 100 mg ≤8°C AU 

1039800021 L-Carnosine RS 100 mg ≤8°C A 

7000390021 Cefazolin RS 100 mg −20 – −30°C F 

7000440021 Cefepime Dihydrochloride RS 100 mg −20 – −30°C F 

7000630021 Cefmetazole RS 100 mg −20 – −30°C F 

Pharmaceutical and Medical Device Regulatory Science Society of Japan (PMRJ) Rev. August 16, 2022


7000460021 Cefotiam Hydrochloride RS 100 mg −20 – −30°C F 

7000590021 Ceftriaxone Sodium RS 100 mg −20 – −30°C F 

1076700021 Celecoxib RS 320 mg ≤8°C AU 

1076000021 Cellacefate for Identification RS 50 mg ≤25°C A 

1076500021 Microcrystalline Cellulose

for Identification RS

50 mg ≤8°C A 

1075300021 Cetotiamine Hydrochloride RS 150 mg ≤8°C A 

1052000021 Chlordiazepoxide RS 500 mg ≤25°C N/A 

1054000021 Chlormadinone Acetate RS 100 mg ≤25°C A 

1053000021 Chlorpheniramine Maleate RS 400 mg ≤25°C AU 

1059000021 Cholecalciferol RS 100 mg ≤8°C RU 

1063000021 Ciclosporin RS 100 mg ≤25°C A 

1070600021 Cilnidipine RS 200 mg ≤8°C A 

1071000021 Cilostazol RS 450 mg ≤25°C A 

1068520021 Ciprofloxacin RS 250 mg ≤8°C A 

1066000021 Cisplatin RS 150 mg ≤8°C AU 

1066600021 Citicoline RS 150 mg ≤8°C A 

7000220021 Clarithromycin RS 100 mg −20 – −30°C F 

1050000021 Clobetasol Propionate RS 50 mg ≤25°C A 

1049000021 Clofibrate RS 800 mg ≤25°C A 

1051000021 Clomifene Citrate RS 200 mg ≤25°C A 

1048900021 Clopidogrel Sulfate RS 200 mg ≤8°C AU 

1058000021 Cortisone Acetate RS 100 mg ≤25°C A 

1060000021 Cyanocobalamin RS 200 mg ≤8°C A 

1078600021 Danazol RS 100 mg ≤25°C A 

1086000021 Deferoxamine Mesilate RS 200 mg ≤25°C A 

1085000021 Deslanoside RS 100 mg ≤25°C AU 

1083000021 Dexamethasone RS 100 mg ≤25°C A 

1061000021 Diethylcarbamazine Citrate RS 200 mg ≤25°C AU 

1068530021 Diflorasone Diacetate RS 100 mg ≤8°C A 

1068500021 Diflucortolone Valerate RS 100 mg ≤25°C A 

1065000021 Digoxin RS 50 mg ≤25°C AU 

1068000021 Dihydroergotoxine Mesilate RS 100 mg ≤25°C A 

1091000021 Dobutamine Hydrochloride RS 300 mg ≤25°C A 

1090300021 Docetaxel RS 370 mg ≤8°C A 

1090500021 Donepezil Hydrochloride RS 450 mg ≤8°C AU 

7000700021 Doripenem RS 150 mg −20 – −30°C F 

1097800021 Dorzolamide Hydrochloride RS 80 mg ≤8°C A 

1086800021 Doxazosin Mesilate RS 200 mg ≤25°C A 

1026000021 Edrophonium Chloride RS 200 mg ≤25°C A 

1029000021 Elcatonin RS See leaflet ≤−20°C F 

1027000021 Enalapril Maleate RS 200 mg ≤25°C A 

1032000021 Endotoxin RS See leaflet ≤8°C A 

1031800021 Entacapone RS 210 mg ≤8°C A 

1031830021 Entacapone Related Substance A

for System Suitability RS

10 mg ≤8°C A 

1027800021 Epalrestat RS 280 mg ≤8°C A 

7000170021 Epirubicin Hydrochloride RS 100 mg −20 – −30°C F 

1028000021 Epitiostanol RS 100 mg ≤8°C R 

1028100021 Eplerenone RS 150 mg ≤8°C A 

1028200021 Epoetin Alfa RS 0.05 mL −80°C F 

1028250021 Epoetin Beta RS 0.25 mL −80°C F 

1030000021 Ergocalciferol RS 100 mg ≤8°C RU 

1031000021 Ergometrine Maleate RS 50 mg ≤8°C N/A 

1028700021 Eribulin Mesilate RS 50 mg −80°C FU 

1028730021 Eribulin Mesilate Related Substance C

for System Suitability RS

5 mg −80°C F 

1021000021 Estradiol Benzoate RS 50 mg ≤25°C A 

Pharmaceutical and Medical Device Regulatory Science Society of Japan (PMRJ) Rev. August 16, 2022


1022000021 Estriol RS 100 mg ≤25°C A 

1024000021 Ethenzamide RS 300 mg ≤25°C A 

1023000021 Ethinylestradiol RS 100 mg ≤25°C AU 

1009000021 Ethyl Aminobenzoate RS 250 mg ≤25°C AU 

1013000021 Ethyl Icosapentate RS 240 mg −20 – −30°C F 

1188800021 Ethyl Loflazepate RS 100 mg ≤8°C N/A 

1114100021 Ethyl Parahydroxybenzoate RS 200 mg ≤8°C A 

1025000021 Etoposide RS 100 mg ≤8°C A 

1127900021 Fenofibrate RS 200 mg ≤8°C A 

1127800021 Fexofenadine Hydrochloride RS 100 mg ≤25°C A 

1127500021 Filgrastim RS 1 mL −80°C F 

1135400021 Fludrocortisone Acetate RS 100 mg ≤8°C A 

1133000021 Fluocinolone Acetonide RS 50 mg ≤25°C A 

1132000021 Fluocinonide RS 100 mg ≤25°C AU 

1134000021 Fluorometholone RS 100 mg ≤25°C A 

1135200021 Flutamide RS 150 mg ≤8°C AU 

1135600021 Fluvoxamine Maleate RS 350 mg ≤25°C AU 

1176000021 Folic Acid RS 500 mg ≤25°C A 

7000830021 Fradiomycin Sulfate RS 200 mg −20 – −30°C F 

1141000021 Furosemide RS 200 mg ≤25°C A 

1135000021 Fursultiamine Hydrochloride RS 200 mg ≤25°C A 

1036000021 Gabexate Mesilate RS 200 mg ≤25°C A 

1034900021 Gatifloxacin RS 500 mg ≤8°C A 

1055500021 Gefarnate RS 170 mg ≤8°C A 

1055700021 Gefitinib RS 160 mg ≤8°C AU 

1045000021 Ginsenoside Rb1 RS 15 mg −20 – −30°C F 

1046000021 Ginsenoside Rg1 RS 15 mg −20 – −30°C F 

1044000021 Gitoxin for Purity RS 10 mg ≤25°C AU 

1048200021 Glimepiride RS 200 mg ≤25°C A 

1048400021 Glucagon RS See leaflet −20 – −30°C F 

1128300021 Glucose RS 1 g ≤8°C A 

1048500021 D-Glucuronolactone RS 100 mg ≤8°C A 

1048000021 Glycyrrhizic Acid RS 30 mg ≤8°C A 

1057000021 Gonadorelin Acetate RS 50 mg −20 – −30°C F 

1047000021 Guaifenesin RS 200 mg ≤25°C A 

1149000021 Heparin Sodium RS See leaflet ≤8°C A 

1149010021 Heparin Sodium for Identification RS 100 mg ≤8°C A 

1056000021 High-molecular Mass Urokinase RS See leaflet −20 – −30°C F 

1118000021 Human Chorionic Gonadotrophin RS See leaflet ≤−20°C F 

1117000021 Human Menopausal Gonadotrophin RS See leaflet ≤−20°C F 

1119000021 Hydrochlorothiazide RS 100 mg ≤25°C A 

1120000021 Hydrocortisone RS 100 mg ≤25°C A 

1122000021 Hydrocortisone Acetate RS 100 mg ≤8°C A 

1123000021 Hydrocortisone Sodium Phosphate RS 100 mg ≤8°C A 

1121000021 Hydrocortisone Succinate RS 100 mg ≤25°C A 

1115600021 Hydroxyethylcellulose for Identification RS 50 mg ≤8°C A 

1015000021 Idoxuridine RS 100 mg ≤25°C A 

1016000021 Imipramine Hydrochloride RS 200 mg ≤25°C A 

1017500021 Indapamide RS 200 mg ≤8°C A 

1019000021 Indometacin RS 350 mg ≤25°C AU 

1017010021 Insulin Aspart RS See leaflet −20 – −30°C F 

1017020021 Insulin Glargine RS See leaflet ≤−20°C F 

1116000021 Insulin Human RS 50 mg −20 – −30°C F 

1018000021 Interleukin-2 RS See leaflet −80°C F 

1015500021 Ipriflavone RS 100 mg ≤25°C A 

1014000021 Isoflurane RS 18 mL ≤8°C R 

1014300021 Isomalt RS 1.5 g ≤8°C A 

1038000021 Kallidinogenase RS See leaflet −20 – −30°C F 

Pharmaceutical and Medical Device Regulatory Science Society of Japan (PMRJ) Rev. August 16, 2022


1105000021 Lactose for Identification RS 50 mg ≤25°C A 

1177000021 Lactulose RS 1.5 g ≤25°C A 

1179100021 Lanoconazole RS 190 mg ≤8°C A 

1179600021 Lansoprazole RS 200 mg ≤8°C A 

1186200021 Lenograstim RS 1 mL −80°C F 

1183100021 Leuprorelin Acetate RS 300 mg −20 – −30°C F 

1183000021 Limaprost RS 10 mg −20 – −30°C FU 

1188500021 Losartan Potassium RS 100 mg ≤25°C A 

1082000021 Low-molecular Mass Heparin RS See leaflet ≤8°C R 

1188000021 Loxoprofen RS 200 mg ≤8°C A 

1180000021 Lysozyme RS 500 mg ≤8°C A 

1156000021 Maltose RS 300 mg ≤25°C A 

1155000021 Manidipine Hydrochloride RS 250 mg ≤8°C AU 

1156300021 D-Mannitol RS 4.6 g ≤8°C A 

1159000021 Mecobalamin RS 450 mg ≤25°C A 

1167500021 Medroxyprogesterone Acetate RS 150 mg ≤8°C A 

1168000021 Menatetrenone RS 300 mg ≤8°C R 

7000960021 Meropenem RS 100 mg −20 – −30°C F 

1160000021 Mestranol RS 100 mg ≤25°C A 

1167000021 Methotrexate RS 800 mg ≤8°C AU 

1166000021 Methoxsalen RS 200 mg ≤25°C A 

1164000021 Methyldopa RS 400 mg ≤25°C A 

1161000021 Methylergometrine Maleate RS 50 mg ≤25°C A 

1114300021 Methyl Parahydroxybenzoate RS 200 mg ≤8°C AU 

1165000021 Methylprednisolone Succinate RS 100 mg ≤25°C A 

1163000021 Methyltestosterone RS 100 mg ≤25°C A 

1162000021 Metildigoxin RS 50 mg ≤25°C AU 

1158000021 Mexiletine Hydrochloride RS 100 mg ≤25°C AU 

1156700021 Miglitol RS 200 mg ≤8°C A 

7000940021 Minocycline Hydrochloride RS 100 mg −20 – −30°C F 

1157300021 Mitiglinide Calcium RS 360 mg ≤8°C A 

1157000021 Mizoribine RS 300 mg ≤8°C A 

1168460021 Montelukast for System Suitability RS 5 mg ≤8°C A 

1168400021 Montelukast Dicyclohexylamine RS 120 mg ≤8°C A 

1168490021 Montelukast Racemate

for System Suitability RS

5 mg ≤8°C A 

1168430021 Montelukast Sodium for Identification RS 50 mg ≤8°C A 

1101000021 Nabumetone RS 200 mg ≤8°C A 

1101500021 Nartograstim RS 1 mL −80°C F 

1100500021 Nateglinide RS 170 mg ≤25°C A 

1108000021 Neostigmine Methylsulfate RS 100 mg ≤25°C A 

1103000021 Nicotinamide RS 500 mg ≤25°C A 

1102000021 Nicotinic Acid RS 500 mg ≤25°C A 

1107000021 Nilvadipine RS 250 mg ≤8°C A 

1104000021 Nizatidine RS 150 mg ≤25°C A 

1109000021 Noradrenaline Bitartrate RS 50 mg ≤8°C AU 

1110000021 Norgestrel RS 350 mg ≤25°C A 

1034800021 Olmesartan Medoxomil RS 200 mg ≤8°C A 

1039000021 Over-sulfated Chondroitin Sulfate

for System Suitability RS

See leaflet ≤8°C A 

1033000021 Oxytocin RS See leaflet −20 – −30°C F 

1034000021 Ozagrel Sodium RS 100 mg ≤25°C A 

1144000021 Paeoniflorin RS 20 mg ≤8°C A 

1114500021 Paroxetine Hydrochloride RS 200 mg ≤8°C AU 

1112800021 Pazufloxacin Mesilate RS 150 mg ≤8°C A 

1149200021 Pemirolast Potassium RS 200 mg ≤25°C A 

1152000021 Pentobarbital RS 100 mg ≤25°C N/A 

1150000021 Perphenazine RS 100 mg ≤25°C A 

Pharmaceutical and Medical Device Regulatory Science Society of Japan (PMRJ) Rev. August 16, 2022


1127000021 Phytonadione RS 200 mg ≤8°C A 

1114800021 Pioglitazone Hydrochloride RS 160 mg ≤8°C AU 

7000820021 Piperacillin RS 100 mg −20 – −30°C F 

1115500021 Pitavastatin Methylbenzylamine RS 100 mg ≤8°C A 

1070000021 Potassium Sucrose Octasulfate RS 1 g −20 – −30°C F 

1153000021 Povidone for Identification RS 50 mg ≤8°C A 

1129400021 Pranlukast RS 100 mg ≤8°C A 

1129000021 Pravastatin

1,1,3,3-Tetramethylbutylammonium RS

200 mg −20 – −30°C F 

1128600021 Prazosin Hydrochloride RS 100 mg ≤25°C A 

1136000021 Prednisolone RS 100 mg ≤25°C A 

1138000021 Prednisolone Acetate RS 100 mg ≤25°C A 

1137000021 Prednisolone Succinate RS 150 mg ≤25°C A 

1130000021 Primidone RS 300 mg ≤25°C A 

1143000021 Probenecid RS 500 mg ≤25°C A 

1142600021 Probucol RS 300 mg ≤25°C A 

1139000021 Prochlorperazine Maleate RS 500 mg ≤25°C A 

1140000021 Progesterone RS 150 mg ≤25°C A 

1142400021 Propiverine Hydrochloride RS 200 mg ≤25°C A 

1114250021 Propyl Parahydroxybenzoate RS 200 mg ≤8°C A 

1128000021 Puerarin RS 20 mg ≤8°C A 

1123800021 Pyridoxal Phosphate RS 200 mg ≤8°C A 

1124000021 Pyridoxine Hydrochloride RS 200 mg ≤25°C A 

1047200021 Quetiapine Fumarate RS 170 mg ≤8°C AU 

1179200021 Rabeprazole Sodium RS 1.35 g ≤8°C A 

1179000021 Ranitidine Hydrochloride RS 100 mg ≤25°C A 

1184000021 Reserpine RS 50 mg ≤25°C A 

1059700021 Residual Solvents Class 1 RS 1.2 mL/ampoule Room

Temperature A (3 ampoules/box)

1059800021 Residual Solvents Class 2A RS 1.2 mL/ampoule Room Temperature A (3 ampoules/box)

1059850021 Residual Solvents Class 2B RS 1.2 mL/ampoule Room Temperature A (3 ampoules/box)

1059860021 Residual Solvents Class 2C RS 1.2 mL/ampoule Room Temperature A  (3 ampoules/box)

1059900021 Residual Solvents for System Suitability RS 1.2 mL/ampoule Room Temperature A (3 ampoules/box)

1185000021 Retinol Acetate RS 200 mg/capsule ≤8°C A (5 capsules/bottle)

1186000021 Retinol Palmitate RS 200 mg/capsule ≤8°C A (5 capsules/bottle)

1181700021 Ribavirin RS 150 mg ≤8°C A 

1182000021 Riboflavin RS 200 mg ≤25°C A 

1183500021 Rilmazafone Hydrochloride RS 200 mg ≤8°C A 

1179900021 Risedronic Acid RS 200 mg ≤25°C A 

1181000021 Ritodrine Hydrochloride RS 250 mg ≤25°C A 

1188600021 Rosuvastatin Calcium RS 400 mg −20 – −30°C FU 

1187000021 Roxatidine Acetate Hydrochloride RS 300 mg ≤25°C A 

7000990021 Roxithromycin RS 100 mg −20 – −30°C FU 

1041000021 Saccharated Pepsin RS 5 g ≤8°C A 

1059100021 Saccharin RS 100 mg ≤8°C A 

1059150021 Saccharin Sodium RS 100 mg ≤8°C A 

1059500021 Sarpogrelate Hydrochloride RS 350 mg ≤8°C A 

1073000021 Scopolamine Hydrobromide RS 200 mg ≤25°C AU 

1077000021 Sennoside A RS 20 mg ≤8°C A 

1078000021 Sennoside B RS 20 mg ≤8°C A 

1075500021 Sevoflurane RS 18 mL ≤8°C RU 

1071100021 Silodosin RS 250 mg ≤8°C A 

1071500021 Simvastatin RS 100 mg −20 – −30°C FU 

1066500021 Sitagliptin Phosphate RS 130 mg ≤8°C A 

Pharmaceutical and Medical Device Regulatory Science Society of Japan (PMRJ) Rev. August 16, 2022


1066510021 Sitagliptin Phosphate  for System Suitability RS  15 mg ≤8°C A 

1068600021 Sivelestat RS 120 mg −20 – −30°C F 

1074000021 Spironolactone RS 200 mg ≤25°C A 

7000350021 Sulbactam RS 100 mg −20 – −30°C F 

1075000021 Sulfadiazine Silver RS 300 mg ≤25°C A 

1172000021 Sulfanilamide for Apparatus Suitability RS 200 mg ≤25°C A 

1173000021 Sulfapyridine for Apparatus Suitability RS 200 mg ≤25°C A 

1072000021 Swertiamarin RS 20 mg ≤8°C A 

1078300021 Tacalcitol RS 4 mg −20 – −30°C FU 

1078400021 Tacrolimus RS 100 mg ≤8°C AU 

7000650021 Tazobactam RS 100 mg −20 – −30°C F 

1086200021 Teprenone RS 170 mg −20 – −30°C F 

1084000021 Testosterone Propionate RS 50 mg ≤25°C A 

1080000021 Thiamine Chloride Hydrochloride RS 1 g ≤25°C A 

1079000021 Thiamylal RS 100 mg ≤25°C A 

1100000021 Thrombin RS See leaflet −20 – −30°C F 

1080500021 Timolol Maleate RS 120 mg ≤8°C A 

1087000021 Tocopherol RS 150 mg ≤8°C A 

1089000021 Tocopherol Acetate RS 150 mg ≤8°C A 

1090000021 Tocopherol Nicotinate RS 150 mg ≤8°C R 

1088000021 Tocopherol Succinate RS 150 mg ≤8°C R 

1099000021 Tolbutamide RS 200 mg ≤25°C A 

1098000021 Tolnaftate RS 200 mg ≤25°C A 

1090200021 Tosufloxacin Tosilate RS 350 mg ≤8°C A 

1093000021 Tranexamic Acid RS 200 mg ≤25°C A 

1099500021 Trehalose RS 600 mg ≤25°C A 

1094000021 Triamcinolone RS 100 mg ≤25°C A 

1095000021 Triamcinolone Acetonide RS 100 mg ≤25°C A 

1093500021 Triazolam RS 200 mg ≤8°C N/A 

1096000021 Trichlormethiazide RS 250 mg ≤25°C A 

1097000021 Trihexyphenidyl Hydrochloride RS 300 mg ≤25°C A 

1099600021 Troxipide RS 250 mg ≤25°C A 

1081000021 Tyrosine for Digestion Test RS 500 mg ≤25°C A 

1175000021 Ubidecarenone RS 150 mg ≤8°C A 

1020000021 Ulinastatin RS See leaflet −20 – −30°C F 

1114340021 Valaciclovir Hydrochloride RS 150 mg ≤8°C A 

1114400021 Valsartan RS 350 mg ≤8°C A 

7000800021 Vancomycin Hydrochloride RS 500 mg −20 – −30°C F 

1174000021 Vanillin for Apparatus Suitability RS 200 mg ≤25°C A 

1113000021 Vasopressin RS See leaflet −20 – −30°C F 

1126000021 Vinblastine Sulfate RS 50 mg −20 – −30°C F 

1125000021 Vincristine Sulfate RS 80 mg −20 – −30°C FU 

1153700021 Voriconazole RS 200 mg ≤8°C AU 

1189000021 Warfarin Potassium RS 350 mg ≤25°C AU 

1067000021 Zidovudine RS 200 mg ≤25°C A 

1078200021 Zonisamide RS 200 mg ≤8°C A 

2. Official Non-pharmacopoeial Reference Standards*

* Former National Institute of Health Sciences Reference Standards

2-1. Reference Standards for Assays and Tests of Japanese Pharmaceutical Codex


2002000021 Estradiol RS 50 mg ≤25°C AU 

2003000021 Estrone RS 50 mg ≤25°C A 

2005000021 Fludroxycortide RS 100 mg ≤25°C A 

Pharmaceutical and Medical Device Regulatory Science Society of Japan (PMRJ) Rev. August 16, 2022

- 7 / 8 -


2001000021 Indocianine Green RS 300 mg ≤8°C A 


2-2. Other Reference Standards

3001000021 Human Growth Hormone RS See leaflet −20 – −30°C F 


3. Ministerial Ordinance coal-tar color for TLC Reference Standards

4001000021 Blue No. 1 for TLC RS 100 mg ≤25°C A 

4002000021 Blue No. 2 for TLC RS 100 mg ≤25°C A 

4035000021 Green No. 3 for TLC RS 100 mg ≤25°C A 

4036000021 Green No. 402 for TLC RS 100 mg ≤25°C A 

4031000021 Orange No. 203 for TLC RS 100 mg ≤25°C A 

4032000021 Orange No. 205 for TLC RS 100 mg ≤25°C A 

4033000021 Orange No. 402 for TLC RS 100 mg ≤25°C A 

4034000021 Orange No. 403 for TLC RS 100 mg ≤25°C A 

4003000021 Red No. 2 for TLC RS 100 mg ≤25°C A 

4004000021 Red No. 3 for TLC RS 100 mg ≤25°C A 

4005000021 Red No. 102 for TLC RS 100 mg ≤25°C A 

4006000021 Red No. 104 (1) for TLC RS 100 mg ≤25°C A 

4007000021 Red No. 105 (1) for TLC RS 100 mg ≤25°C A 

4008000021 Red No. 106 for TLC RS 100 mg ≤25°C A 

4009000021 Red No. 202 for TLC RS 100 mg ≤25°C A 

4010000021 Red No. 203 for TLC RS 100 mg ≤25°C A 

4011000021 Red No. 204 for TLC RS 100 mg ≤25°C AU 

4012000021 Red No. 218 for TLC RS 100 mg ≤25°C A 

4013000021 Red No. 221 for TLC RS 100 mg ≤25°C AU 

4014000021 Red No. 223 for TLC RS 100 mg ≤25°C A 

4015000021 Red No. 230 (1) for TLC RS 100 mg ≤25°C A 

4016000021 Red No. 230 (2) for TLC RS 100 mg ≤25°C A 

4017000021 Red No. 231 for TLC RS 100 mg ≤25°C A 

4018000021 Red No. 232 for TLC RS 100 mg ≤25°C A 

4019000021 Red No. 502 for TLC RS 100 mg ≤25°C A 

4020000021 Red No. 503 for TLC RS 100 mg ≤25°C A 

4021000021 Red No. 504 for TLC RS 100 mg ≤25°C A 

4022000021 Red No. 505 for TLC RS 100 mg ≤25°C A 

4023000021 Red No. 506 for TLC RS 100 mg ≤25°C A 

4024000021 Yellow No. 4 for TLC RS 100 mg ≤25°C A 

4025000021 Yellow No. 5 for TLC RS 100 mg ≤25°C A 

4026000021 Yellow No. 201 for TLC RS 100 mg ≤25°C A 

4027000021 Yellow No. 401 for TLC RS 100 mg ≤25°C A 

4028000021 Yellow No. 403 (1) for TLC RS 100 mg ≤25°C A 

4029000021 Yellow No. 404 for TLC RS 100 mg ≤25°C A 

4030000021 Yellow No. 405 for TLC RS 100 mg ≤25°C A 

4. Japan's Specifications and Standards for Food Additives Reference Standards

5002000021 Food Blue No. 1 RS 100 mg ≤25°C A 

5003000021 Food Blue No. 2 RS 100 mg ≤25°C A 

5013000021 Food Green No. 3 RS 100 mg ≤25°C A 

5004000021 Food Red No. 2 RS 100 mg ≤25°C A 

5005000021 Food Red No. 3 RS 100 mg ≤25°C A 

Pharmaceutical and Medical Device Regulatory Science Society of Japan (PMRJ) Rev. August 16, 2022


5006000021 Food Red No. 40 RS 100 mg ≤25°C A 

5007000021 Food Red No. 102 RS 100 mg ≤25°C A 

5008000021 Food Red No. 104 RS 100 mg ≤25°C A 

5009000021 Food Red No. 105 RS 100 mg ≤25°C A 

5010000021 Food Red No. 106 RS 100 mg ≤25°C A 

5011000021 Food Yellow No. 4 RS 100 mg ≤25°C A 

5012000021 Food Yellow No. 5 RS 100 mg ≤25°C A 

5015000021 Natamycin RS 150 mg ≤8°C A 

5014000021 Nisin RS 500 mg −20 – −30°C F 

5001000021 Xylitol RS 3.7 g ≤25°C A 

5. IMWP RS

8005000021 IMWP RS on Favipiravir 100 mg ≤8°C A 


* This reference standard (IMWP RS on Favipiravir) is used for quantification of favipiravir and confirmation of system suitability

for the International Meeting of World Pharmacopoeias (IMWP) monographs on Favipiravir and on Favipiravir tablets.


The storage temperatures are defined as follows:

Room Temperature : 1 – 30°C;≤25°C : 1 – 25°C;≤5°C : Refrigerate (1 – 5°C);≤8°C : Refrigerate (1 – 8°C);≤−20°C : Freeze (≤−20°C);−20 – −30°C : ≤−20°C. Avoid storage below −30°C because the container may not withstand such low temperatures.

−80°C : Freeze (−80°C ± 10°C)

运输条件

A : at ambient temperature;R : kept refrigerated;F : kept frozen (with Dry-Ice);AU : at ambient temperature, dangerous goods;RU : kept refrigerated, dangerous goods

FU : kept frozen (with Dry-Ice), dangerous goods;N/A : Not available for overseas shipping

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