Japanese Orange Book English Version

Notice: This gJapanese Orange Book English Versionh aims to show worldwide the Japanese dissolution specifications of oral products included in the third section of the Japanese Pharmaceutical Codex (Japanese orange book). The Japanese orange book established following the quality reevaluation for ten years, to assure the quality of generic drugs by comparing dissolutions between innovator and generic products and also to establish dissolution specifications for all products including innovators approved before the test became mandatory in Japanese regulation in 1995. We started the translation from the final volume of orange book published in 2011 and will continue for several years to reach the first volume. When and if any discrepancy arises the Japanese original is authentic.

Explanation of dissolution profile fugures

Explanation of physicochemical property tables

 Products  Products (in Japanese)  Monographs Dissolution Profiles of Standard Product Physico-
chemical Properties
         
2010 (Heisei 22) March Issue Notified on May 2008  
Chlorpheniramine Maleate 0.5 mg/g, Salicylamide 45 mg/g, Acetaminophen 25 mg/g and Anhydrous Caffeine 5 mg/g Granules ƒNƒƒ‹ƒtƒFƒjƒ‰ƒ~ƒ“ƒ}ƒŒƒCƒ“Ž_‰–0.5mg/gEƒTƒŠƒ`ƒ‹ƒAƒ~ƒh45mg/gEƒAƒZƒgƒAƒ~ƒmƒtƒFƒ“25mg/gE–³…ƒJƒtƒFƒCƒ“5mg/g è÷—±  
Chlorpheniramine Maleate 3 mg/g, Salicylamide 270 mg/g, Acetaminophen 150 mg/g and Anhydrous Caffeine 30 mg/g Granules ƒNƒƒ‹ƒtƒFƒjƒ‰ƒ~ƒ“ƒ}ƒŒƒCƒ“Ž_‰–3mg/gEƒTƒŠƒ`ƒ‹ƒAƒ~ƒh270mg/gEƒAƒZƒgƒAƒ~ƒmƒtƒFƒ“150mg/gE–³…ƒJƒtƒFƒCƒ“30mg/g è÷—±  
Chlorpheniramine Maleate 3 mg/g, Salicylamide 270 mg/g, Acetaminophen 150 mg/g and Anhydrous Caffeine 30 mg/g Powders ƒNƒƒ‹ƒtƒFƒjƒ‰ƒ~ƒ“ƒ}ƒŒƒCƒ“Ž_‰–3mg/gEƒTƒŠƒ`ƒ‹ƒAƒ~ƒh270mg/gEƒAƒZƒgƒAƒ~ƒmƒtƒFƒ“150mg/gE–³…ƒJƒtƒFƒCƒ“30mg/g ŽU  
Diazepam Powder ƒWƒAƒ[ƒpƒ€ŽU  
*Diazepam Tablets *ƒWƒAƒ[ƒpƒ€ù  
Dimemorfan Phosphate Powder ƒWƒƒ‚ƒ‹ƒtƒ@ƒ“ƒŠƒ“Ž_‰–ŽU  
Dimemorfan Phosphate Tablets ƒWƒƒ‚ƒ‹ƒtƒ@ƒ“ƒŠƒ“Ž_‰–ù  
*Doxazosin Mesilate Tablets *ƒhƒLƒTƒ]ƒVƒ“ƒƒVƒ‹Ž_‰–ù  
Ergotamine Tartrate, Anhydrous Caffeine and Isopropylantipyrine Tablets ƒGƒ‹ƒSƒ^ƒ~ƒ“ŽðÎŽ_‰–E–³…ƒJƒtƒFƒCƒ“EƒCƒ\ƒvƒƒsƒ‹ƒAƒ“ƒ`ƒsƒŠƒ“ù  
Hydroxyzine Hydrochloride Tablets ƒqƒhƒƒLƒVƒWƒ“‰–Ž_‰–ù  
Levothyroxine Sodium Powder ƒŒƒ{ƒ`ƒƒLƒVƒ“ƒiƒgƒŠƒEƒ€ŽU  
Lomerizine Hydrochloride Tablets ƒƒƒŠƒWƒ“‰–Ž_‰–ù  
Monoammonium Glycyrrhizinate 35 mg, Glycine 25 mg, DL-Methionine 25 mg Tablets ƒOƒŠƒ`ƒ‹ƒŠƒ`ƒ“Ž_ƒ‚ƒmƒAƒ“ƒ‚ƒjƒEƒ€35mgEƒOƒŠƒVƒ“25mgEDL-ƒƒ`ƒIƒjƒ“25mgù  
Pentoxyverine Citrate Tablets ƒyƒ“ƒgƒLƒVƒxƒŠƒ“ƒNƒGƒ“Ž_‰–ù  
Prazosin Hydrochloride Tablets ƒvƒ‰ƒ]ƒVƒ“‰–Ž_‰–ù  
Promethazine Methylenedisalicylate Fine Granules ƒvƒƒƒ^ƒWƒ“ƒƒ`ƒŒƒ“ƒWƒTƒŠƒ`ƒ‹Ž_‰–×—±  
Terguride Tablets ƒeƒ‹ƒOƒŠƒhù  
Tropisetoron Hydrochloride Capsules ƒgƒƒsƒZƒgƒƒ“‰–Ž_‰–ƒJƒvƒZƒ‹  
 
2010 (Heisei 22) March Issue Notified on November 2008  
Calcium Disodium Edetate Enteric-coated Tablets ƒGƒfƒgŽ_ƒJƒ‹ƒVƒEƒ€“ñƒiƒgƒŠƒEƒ€’°—nù  
Hydroxyzine Pamoate Tablets ƒqƒhƒƒLƒVƒWƒ“ƒpƒ‚Ž_‰–ù  
Thiamine Disulfide 10 mg, Pyridoxine Hydrochloride 50 mg and Cyanocobalamin 0.25 mg Tablets ƒ`ƒAƒ~ƒ“ƒWƒXƒ‹ƒtƒBƒh10mgEƒsƒŠƒhƒLƒVƒ“‰–Ž_‰–50mgEƒVƒAƒmƒRƒoƒ‰ƒ~ƒ“0.25mg ù  
 
 
2010 (Heisei 22) February Issue Notified on January 2008  
Actarit Tablets ƒAƒNƒ^ƒŠƒbƒgù  
Ascorbic Acid 200 mg and Calcium Pantothenate 3 mg Tablets ƒAƒXƒRƒ‹ƒrƒ“Ž_200mgEƒpƒ“ƒgƒeƒ“Ž_ƒJƒ‹ƒVƒEƒ€3mgù  
Ascorbic Acid 200 mg/g and Calcium Pantothenate 3 mg/g Granules ƒAƒXƒRƒ‹ƒrƒ“Ž_200mg/gEƒpƒ“ƒgƒeƒ“Ž_ƒJƒ‹ƒVƒEƒ€3mg/gè÷—±  
Benfotiamine, Pyridoxine Hydrochloride and Cyanocobalamin Capsules ƒxƒ“ƒtƒHƒ`ƒAƒ~ƒ“EƒsƒŠƒhƒLƒVƒ“‰–Ž_‰–EƒVƒAƒmƒRƒoƒ‰ƒ~ƒ“ƒJƒvƒZƒ‹  
Benfotiamine 138.3 mg/g, Pyridoxine Hydrochloride 100 mg/g and Cyanocobalamin 1 mg/g Powder ƒxƒ“ƒtƒHƒ`ƒAƒ~ƒ“138.3mg^gEƒsƒŠƒhƒLƒVƒ“‰–Ž_‰–100mg^gEƒVƒAƒmƒRƒoƒ‰ƒ~ƒ“1mg^g ŽU  
Carpipramine Hydrochloride Tablets ƒJƒ‹ƒsƒvƒ‰ƒ~ƒ“‰–Ž_‰–ù  
Chlormadinone Acetate Tablets ƒNƒƒ‹ƒ}ƒWƒmƒ“|Ž_ƒGƒXƒeƒ‹ù  
Clemastine Fumarate Dry Syrup ƒNƒŒƒ}ƒXƒ`ƒ“ƒtƒ}ƒ‹Ž_‰–ƒhƒ‰ƒCƒVƒƒbƒv  
Clemastine Fumarate Powder ƒNƒŒƒ}ƒXƒ`ƒ“ƒtƒ}ƒ‹Ž_‰–ŽU  
Clemastine Fumarate Tablets ƒNƒŒƒ}ƒXƒ`ƒ“ƒtƒ}ƒ‹Ž_‰–ù  
Clomipramine Hydrochloride Tablets ƒNƒƒ~ƒvƒ‰ƒ~ƒ“‰–Ž_‰–ù  
Cyclofenil Tablets ƒVƒNƒƒtƒFƒjƒ‹ù  
Diphenhydramine Hydrochloride Tablets ƒWƒtƒFƒ“ƒqƒhƒ‰ƒ~ƒ“‰–Ž_‰–ù  
Diprophylline 25 mg, Methoxyphenamine Hydrochloride 25 mg, Noscapine 5 mg and Chlorpheniramine Maleate 2 mg Capsules ƒWƒvƒƒtƒBƒŠƒ“25mgEƒƒgƒLƒVƒtƒFƒiƒ~ƒ“‰–Ž_‰–25mgEƒmƒXƒJƒsƒ“5mgEƒNƒƒ‹ƒtƒFƒjƒ‰ƒ~ƒ“ƒ}ƒŒƒCƒ“Ž_‰–2mg ƒJƒvƒZƒ‹  
Ethambutol Hydrochloride Tablets ƒGƒ^ƒ“ƒuƒg[ƒ‹‰–Ž_‰–ù  
*Faropenem Sodium for Syrup *ƒVƒƒbƒv—pƒtƒ@ƒƒyƒlƒ€ƒiƒgƒŠƒEƒ€  
*Faropenem Sodium Tablets *ƒtƒ@ƒƒyƒlƒ€ƒiƒgƒŠƒEƒ€ù  
Fursultiamine Hydrochloride Tablets ƒtƒ‹ƒXƒ‹ƒ`ƒAƒ~ƒ“‰–Ž_‰–ù  
Fursultiamine Tablets ƒtƒ‹ƒXƒ‹ƒ`ƒAƒ~ƒ“ù  
Loperamide Hydrochloride Dry Syrup ƒƒyƒ‰ƒ~ƒh‰–Ž_‰–ƒhƒ‰ƒCƒVƒƒbƒv  
Methoxsalen Tablets ƒƒgƒLƒTƒŒƒ“ù
Norethisterone Tablets ƒmƒ‹ƒGƒ`ƒXƒeƒƒ“ù  
Norethisterone and Mestranol Tablets ƒmƒ‹ƒGƒ`ƒXƒeƒƒ“EƒƒXƒgƒ‰ƒm[ƒ‹ù  
Norethisterone 5 mg and Mestranol 0.05 mg Tablets ƒmƒ‹ƒGƒ`ƒXƒeƒƒ“5mgEƒƒXƒgƒ‰ƒm[ƒ‹0.05mgù  
Octotiamine 25 mg, Riboflavin 2.5 mg, Pyridoxine Hydrochloride 40 mg and Cyanocobalamin 0.25 mg Tablets ƒIƒNƒgƒ`ƒAƒ~ƒ“25mgEƒŠƒ{ƒtƒ‰ƒrƒ“2.5mgEƒsƒŠƒhƒLƒVƒ“‰–Ž_‰–40mgEƒVƒAƒmƒRƒoƒ‰ƒ~ƒ“0.25mg ù  
Pergolide Mesilate Tablets ƒyƒ‹ƒSƒŠƒhƒƒVƒ‹Ž_‰–ù  
*Rifampicin Capsules *ƒŠƒtƒ@ƒ“ƒsƒVƒ“ƒJƒvƒZƒ‹  
Rokitamycin Dry Syrup ƒƒLƒ^ƒ}ƒCƒVƒ“ƒhƒ‰ƒCƒVƒƒbƒv  
*Zolpidem Tartrate Tablets *ƒ]ƒ‹ƒsƒfƒ€ŽðÎŽ_‰–ù  
 
Notified on March 2008  
Aceglatone Tablets ƒAƒZƒOƒ‰ƒgƒ“ù  
Adenosine 5f-Triphosphate Disodium Enteric-coated Tablets ƒAƒfƒmƒVƒ“ŽOƒŠƒ“Ž_“ñƒiƒgƒŠƒEƒ€’°—nù  
Amoxicillin 100 mgg (potency) and Potassium Clavulanate 50 mgg (potency) Granules ƒAƒ‚ƒLƒVƒVƒŠƒ“100mg/gi—͉¿jEƒNƒ‰ƒuƒ‰ƒ“Ž_ƒJƒŠƒEƒ€50mg/gi—͉¿jè÷—±  
**42 monographs remain to be translated in this issue.  
 
2008 (Heisei 20) March Issue Notified on September 2007  
Bisbentiamine Tablets ƒrƒXƒxƒ“ƒ`ƒAƒ~ƒ“ù  
Bopindolol Malonate Tablets ƒ{ƒsƒ“ƒhƒ[ƒ‹ƒ}ƒƒ“Ž_‰–ù  
Calcium Pantothenate 100 mg/g, Riboflavin 3 mg/g, Pyridoxine Hydrochloride 30 mg/g and Nicotinamide 15 mg/g Granules ƒpƒ“ƒgƒeƒ“Ž_ƒJƒ‹ƒVƒEƒ€100 mg/gEƒŠƒ{ƒtƒ‰ƒrƒ“3 mg/gEƒsƒŠƒhƒLƒVƒ“‰–Ž_‰–30 mg/gEƒjƒRƒ`ƒ“Ž_ƒAƒ~ƒh15 mg/g è÷—±  
Clocapramine Hydrochloride Granules ƒNƒƒJƒvƒ‰ƒ~ƒ“‰–Ž_‰–è÷—±  
Cyproheptadine Hydrochloride Powder ƒVƒvƒƒwƒvƒ^ƒWƒ“‰–Ž_‰–ŽU  
Cyproheptadine Hydrochloride Tablets ƒVƒvƒƒwƒvƒ^ƒWƒ“‰–Ž_‰–ù  
Egualen Sodium Granules ƒGƒOƒAƒŒƒ“ƒiƒgƒŠƒEƒ€è÷—±  
Felodipine Tablets ƒtƒFƒƒWƒsƒ“ù  
Granisetron Hydrochloride Fine Granules ƒOƒ‰ƒjƒZƒgƒƒ“‰–Ž_‰–×—±  
Granisetron Hydrochloride Tablets ƒOƒ‰ƒjƒZƒgƒƒ“‰–Ž_‰–ù  
Levodopa 100 mg and Benserazide Hydrochloride 28.5 mg Tablets ƒŒƒ{ƒhƒp100 mgEƒxƒ“ƒZƒ‰ƒWƒh‰–Ž_‰–28.5 mg ù  
Lithium Carbonate Tablets ’YŽ_ƒŠƒ`ƒEƒ€ù  
Mabuterol Hydrochloride Tablets ƒ}ƒuƒeƒ[ƒ‹‰–Ž_‰–ù  
Methylmethioninesulfonium Chloride Granules ƒƒ`ƒ‹ƒƒ`ƒIƒjƒ“ƒXƒ‹ƒzƒjƒEƒ€ƒNƒƒ‰ƒCƒhè÷—±  
Methylmethioninesulfonium Chloride Tablets ƒƒ`ƒ‹ƒƒ`ƒIƒjƒ“ƒXƒ‹ƒzƒjƒEƒ€ƒNƒƒ‰ƒCƒhù  
*Mosapride Citrate Powder *ƒ‚ƒTƒvƒŠƒhƒNƒGƒ“Ž_‰–ŽU  
*Sarpogrelate Hydrochloride Fine Granules *ƒTƒ‹ƒ|ƒOƒŒƒ‰[ƒg‰–Ž_‰–×—±  
Sobuzoxane Fine Granules ƒ\ƒuƒ]ƒLƒTƒ“×—±  
Tamsulosin Hydrochloride Capsules ƒ^ƒ€ƒXƒƒVƒ“‰–Ž_‰–ƒJƒvƒZƒ‹  
Toremifene Citrate Tablets ƒgƒŒƒ~ƒtƒFƒ“ƒNƒGƒ“Ž_‰–ù  
 
Notified on November 2007  
Ampicillin Capsules ƒAƒ“ƒsƒVƒŠƒ“ƒJƒvƒZƒ‹  
Ampicillin Dry Syrup ƒAƒ“ƒsƒVƒŠƒ“ƒhƒ‰ƒCƒVƒƒbƒv  
Ampicillin Granules ƒAƒ“ƒsƒVƒŠƒ“è÷—±  
Ampicillin 125 mg (potency) and Cloxacillin Sodium 125 mg (potency) Capsules ƒAƒ“ƒsƒVƒŠƒ“125 mg (—͉¿)EƒNƒƒLƒTƒVƒŠƒ“ƒiƒgƒŠƒEƒ€125 mg (—͉¿) ƒJƒvƒZƒ‹  
Ampicillin 125 mg (potency) and Cloxacillin Sodium 125 mg (potency) Tablets ƒAƒ“ƒsƒVƒŠƒ“ 125 mg (—͉¿)EƒNƒƒLƒTƒVƒŠƒ“ƒiƒgƒŠƒEƒ€ 125 mg (—͉¿) ù  
Benzylhydrochlorothiazide Tablets ƒxƒ“ƒ`ƒ‹ƒqƒhƒƒNƒƒƒ`ƒAƒWƒhù  
Calcium Pantothenate 30 mg/g, Riboflavin 3 mg/g, Pyridoxine Hydrochloride 5 mg/g, Nicotinamide 30 mg/g, Ascorbic Acid 200 mg/g and Thiamine Nitrate 3 mg/g Granules ƒpƒ“ƒgƒeƒ“Ž_ƒJƒ‹ƒVƒEƒ€30 mg/gEƒŠƒ{ƒtƒ‰ƒrƒ“3mg/gEƒsƒŠƒhƒLƒVƒ“‰–Ž_‰–5 mg/gEƒjƒRƒ`ƒ“Ž_ƒAƒ~ƒh30 mg/gEƒAƒXƒRƒ‹ƒrƒ“Ž_200 mg/gEƒ`ƒAƒ~ƒ“É‰»•¨3 mg/g è÷—±  
d-Chlorpheniramine Maleate Extenderelease Tablets d-ƒNƒƒ‹ƒtƒFƒjƒ‰ƒ~ƒ“ƒ}ƒŒƒCƒ“Ž_‰–™•úù  
Epirizole Granules ƒGƒsƒŠƒ][ƒ‹è÷—±  
Epirizole Tablets ƒGƒsƒŠƒ][ƒ‹ù  
Ethyl Loflazepate Fine Granules ƒƒtƒ‰ƒ[ƒvŽ_ƒGƒ`ƒ‹×—±  
Ethyl Loflazepate Tablets ƒƒtƒ‰ƒ[ƒvŽ_ƒGƒ`ƒ‹ù  
*Griseofulvin Tablets *ƒOƒŠƒZƒIƒtƒ‹ƒrƒ“ù  
Guaifenesin Powder ƒOƒAƒCƒtƒFƒlƒVƒ“ŽU  
Mequitazine Fine Granules ƒƒLƒ^ƒWƒ“×—±  
Mitotane Capsules ƒ~ƒgƒ^ƒ“ƒJƒvƒZƒ‹  
Mosapramine Hydrochloride Granules ƒ‚ƒTƒvƒ‰ƒ~ƒ“‰–Ž_‰–è÷—±  
Mosapramine Hydrochloride Tablets ƒ‚ƒTƒvƒ‰ƒ~ƒ“‰–Ž_‰–ù  
Ondansetron Hydrochloride Tablets ƒIƒ“ƒ_ƒ“ƒZƒgƒƒ“‰–Ž_‰–ù  
Pentoxyverine Citrate Powder ƒyƒ“ƒgƒLƒVƒxƒŠƒ“ƒNƒGƒ“Ž_‰–ŽU  
Perphenazine Fendizoate Powder ƒyƒ‹ƒtƒFƒiƒWƒ“ƒtƒFƒ“ƒWƒ]Ž_‰–ŽU  
Phenethicillin Potassium Tablets ƒtƒFƒlƒ`ƒVƒŠƒ“ƒJƒŠƒEƒ€ù  
Phenytoin 67 mg and Phenobarbital 33 mg Tablets ƒtƒFƒjƒgƒCƒ“67 mgEƒtƒFƒmƒoƒ‹ƒrƒ^[ƒ‹33 mg ù  
Pranlukast Capsules ƒvƒ‰ƒ“ƒ‹ƒJƒXƒgƒJƒvƒZƒ‹  
*Pravastatin Sodium Fine Granules *ƒvƒ‰ƒoƒXƒ^ƒ`ƒ“ƒiƒgƒŠƒEƒ€×—±  
*Pravastatin Sodium Tablets *ƒvƒ‰ƒoƒXƒ^ƒ`ƒ“ƒiƒgƒŠƒEƒ€ù  
Simvastatin Tablet ƒVƒ“ƒoƒXƒ^ƒ`ƒ“ù  
Tocopherol Nicotinate Capsules ƒgƒRƒtƒFƒ[ƒ‹ƒjƒRƒ`ƒ“Ž_ƒGƒXƒeƒ‹ƒJƒvƒZƒ‹  
Tocopherol Nicotinate Fine Granules ƒgƒRƒtƒFƒ[ƒ‹ƒjƒRƒ`ƒ“Ž_ƒGƒXƒeƒ‹×—±  

*These products were newly added to Japanese Pharmacoepia after publication of the Pharmaceutical Codex.

Division of Drugs, National Institute of Health Sciences