Establishment of the Japanese Pharmacopoeia Fifteenth Edition

G/TBT/N/JPN/154

Establishment of the Japanese Pharmacopoeia Fifteenth edition

Description of content：

The Fifteenth edition of the Japanese Pharmacopoeia shall be established as follows；

To establish 1 article under the section of General Notice ( List 1 )

To amend 3 articles under the section of General Notice ( List 2 )

To establish 1 article under the section General Rules for Preparations ( List 3 )

To amend 7 articles under the section of General Rules for Preparations ( List 4 )

To amend 3 articles under the section of General Rules for Crude Drugs ( List 5 )

To establish 1 test method under the section of General Tests, Process and Apparatus ( List 6 )

To amend 14 test methods under the section of General Tests, Process and Apparatus ( List 7 )

To delete 4 test methods under the section of General Tests, Process and Apparatus ( List 8 )

To delete 8 monographs under the section of Monographs ( List 9 )

To establish 102 monographs under the section of Monographs ( List 10 )

To amend 275 monographs under the section of Monographs ( List 11 )

To establish 5 paragraphs under the section of General Information ( List 12 )

To amend 1 paragraph under the section of General Information ( List 13 )

List 1

4

List 2

5, 8, 15

List 3

Transdermal Systems

List 4

General Notices for Preparations, Extracts, Capsules, Tablets, Injections, Plasters and Pressure Sensitive Adhesives Tapes, Ophthalmic Solutions

List 5

1, 5, 6

List 6

Uniformity of Dosage Units

List 7

Ammonium Limit Test, Residue on Ignition / Sulphated Ash Test, Microbial Assay for Antibiotics, Crude Drugs Test, Microbial Limit Test for Crude Drugs, Particulate Matter in Injectables, Arsenic Limit Test, Specific Surface Area, Boiling Point and Distilling Range Test, Test Methods for Plastic Containers, Particle Size Determination, Disintegration, Melting Point Determination, Dissolution

List 8

Volatile Contaminants in Ethanol, Absorbance Ration Method, Methoxyl Assay,

Paper Chromatography,

List 9

（1）Cefetamet Pivoxil Hydrochloride （2）Secretin

（3）Cefamandole Sodium （4）Cefaloridine

（5）Cefoxitin Sodium （6）Cefradine

（7）Ticarcillin Sodium （8）Cefoselis Sulfate

List 10

（1）L－Aspartic Acid （2）Atenolol

（3）Amphotericin B Tablets （4）Amphotericin B Syrup

（5）Amphotericin B Injection （6）Alacepril

（7）Alacepril Tablets （8）L－Arginine

（9）Arbekacin Sulfate Injection （10）Ethyl Icosapentate

（11）Isoflurane （12）Idarubicin Hydrochloride Injection

（13）Imipenem and Cilastatin for Injection （14）Urapidil

（15）Etidronate Disodium （16）Etidronate Disodium Tablets

（17）Etodolac （18）Clarithromycin Tablets

（19）Clinda mycin Hydrochloride Capsules （20）Croscarmellose Sodium

（21）Chenodeoxycholic Acid （22）Gonadorelin Acetate

（23）Saccharin （24）Zaltoprofen

（25）Zaltoprofen Tablets （26）Cilastatin Sodium

（27）Cilostazol （28）Cilostazol Tablets

（29）Sulpiride Capsules （30）Sulpiride Tablets

（31）Human Menopausal Gonadotrophin （32）Cefaclor Capsules

（33）Cefaclor Extended-Release Granules （34）Cefaclor Fine Granules

（35）Cefozopran Hydrochloride for Injection （36）Cefotiam Hydrochloride for Injection

（37）Cefcapene Pivoxil Hydrochloride Fine Granules （38）Cefcapene Pivoxil Hydrochloride Tablets

（39）Cefditoren Pivoxil Fine Granules （40）Cefditoren Pivoxil Tablets

（41）Cefdinir Capsules （42）Cefdinir Fine Granules

（43）Cefteram Pivoxil Fine Granules （44）Celmoleukin (Genetical Recombination)

（45）Taurine （46）Tamsulosin Hydrochloride

（47）Timolol Maleate （48）Teceleukin (Genetical Recombination)

（49）Teceleukin for Injection (Genetical Recombination)

（50）Doxifluridine

（51）Doxifluridine Capsules （52）Trimetazidine Hydrochloride Tablets

（53）Nicergoline （54）Nicergoline Powder

（55）Nicergoline Tablets （56）Nitrendipine

（57）Nitrendipine Tablets （58）Parnaparin Sodium

（59）Haloperidol Tablets （60）Vancomycin Hydrochloride for Injection

（61）Piperacillin Sodium for Injection （62）Faropenem Sodium Tablets

（63）Faropenem Sodium for Syrup （64）Bucillamine

（65）Pravastatin Sodium （66）Pullulan

（67）Propranolol Hydrochloride Tablets （68）Bezafibrate

（69）Bezafibrate Sustained-Release Tablets （70）Betahistine Mesilate Tablets

（71）Betamethasone Tablets

（72）Beta Methasone Valerate and Gentamicin Sulfate Cream

（73）Betamethasone Valerate and Gentamicin Sulfate Ointment

（74）Verapamil Hydrochloride Tablets （75）Voglibose

（76）Voglibose Tablets （77）Fosfomycin Sodium for Injection

（78）Metoprolol Tartrate （79）Metoprolol Tartrate Tablets

（80）Metformin Hydrochloride （81）Metformin Hydrochloride Tablets

（82）Metronidazole Tablets （83）Mefloquine Hydrochloride

（84）Lisinopril Hydrate （85）Lisinopril Tablets

（86）Ritodrine Hydrochloride （87）Ritodrine Hydrochloride Tablets

（88）Rifampicin Capsules （89）Limaprost Alfadex

（90）Roxatidine Acetate Hydrochloride

（91）RoxatidineAcetate Hydrochloride Extended-release Capsules

（92）Polygonatum Rhizome （93）Kakkonto Extract

（94）Kamishoyosan Extract （95）Saireito Extract

（96）Eleutherococcus Senticosus Rhizome （97）DaioKanzoto Extract

（98）Beninacasa Seed （99）Dolichos Seed

（100）Hochuekkito Extract （101）Ryokeijutsukanto Extract

（102）Nelumbo Seed

List 11

（1）Actinomycin D （2）Aclarubicin Hydrochloride

（3）Acrinol Hydrate （4）Aztreonam

（5）Astromicin Sulfate （6）Aspoxicillin Hydrate

（7）Amikacin Sulfate （8）Amphotericin B

（9）Amoxicillin Hydrate （10）L－Arginine Hydrochloride

（11）Alprostadil Alfadex （12）Arbekacin Sulfate

（13）Anhydrous Ampicillin （14）Ampicillin Hydrate

（15）Ampicillin Sodium （16）Isepamicin Sulfate

（17）Isophane Insulin Injection (Aqueous Suspension)

（18）Idarubicin Hydrochloride

（19）Imipenem Hydrate （20）Insulin

（21）Insulin Injection

（22）Insuiln Zinc Injection (Aqueous Suspension)

（23）Crystalline Insulin Zinc Injection (Aqueous Suspension)

（24）Amorphous Insulin Zinc Injection (Aqueous Suspension)

（25）Ethanol （26）Dehydrated Ethanol

（27）Ethanol for Disinfection （28）Etilefrine Hydrochloride

（29）Epirubicin Hydrochloride （30）Erythromycin

（31）Erythromycin Ethylsuccinate （32）Erythromycin Stearate

（33）Erythromycin Lactobionate （34）Enviomycin Sulfate

（35）Enflurane （36）Oxytetracycline Hydrochloride

（37）Oxytocin （38）Oxytocin Injection

（39）Kanamycin Monosulfate （40）Kanamycin Sulfate

（41）L－Carbocisteine （42）Carumonam Sodium

（43）Kitasamycin （44）Kitasamycin Acetate

（45）Kitasamycin Tartrate （46）Citric Acid Hydrate

（47）Anhydrous Citric Acid （48）Sodium Citrate Hydrate

（49）Potassium Clavulanate （50）Griseofulvin

（51）Clindamycin Hydrochloride （52）Clindamycin Phosphate

（53）Calcium Gluconate Hydrate （54）Cloxacillin SodiumHydrate

（55）Chloramphenicol （56）Chloramphenicol Palmitate

（57）Chlorpheniramine Maleate （58）Chlorpheniramine Maleate Powder

（59）Chlorpheniramine Maleate Tablets （60）Chlorpheniramine Maleate Injection

（61）d－Chlorpheniramine Maleate （62）Chlorpromazine Hydrochloride Tablets

（63）Ketoprofen （64）Gentamicin Sulfate

（65）Wheat Starch （66）Colistin Sulfate

（67）Colistin Sodium Methanesulfonate （68）Cortisone Acetate

（69）Cycloserine （70）Saccharin Sodium Hydrate

（71）Santonin （72）Cyanamide

（73）Cyanocobalamin （74）Cyanocobalamin Injection

（75）Ciclacillin （76）Dicloxacillin Sodium Hydrate

（77）Sisomicin Sulfate （78）Siccanin

（79）Zinostatin Stimalamer （80）Dibekacin Sulfate

（81）Dimercaprol （82）Dimercaprol Injection

（83）Josamycin （84）Josamycin Propionate

（85）Water （86）Purified Water

（87）Sterile Purified Water （88）Water for Injection

（89）Streptomycin Sulfate （90）Spiramycin Acetate

（91）Spectinomycin Hydrochloride Hydrate （92）Sulpiride

（93）Sulbenicillin Sodium （94）Cefaclor

（95）Cefazolin Sodium （96）Cefazolin Sodium Hydrate

（97）Cefatrizine Propulene Glycolate （98）Cefadroxil

（99）Cefalotin Sodium （100）Cefixime

（101）Cefepime Dihydrochloride Hydrate （102）Cefozopran Hydrochloride

（103）Cefotiam Hydrochloride （104）Cefotiam Hexetil Hydrochloride

（105）Cefotetan

（106）Cefcapene Pivoxil Hydrochloride Hydrate

（107）Cefditoren Pivoxil

（108）Cefdinir

（109）Cefsulodin Sodium

（110）Ceftazidime Hydrate

（111）Ceftizoxime Sodium （112）Ceftibuten Hydrate

（113）Ceftriaxone Sodium Hydrate （114）Cefpiramide Sodium

（115）Cefpodoxime Proxetil （116）Cefminox Sodium Hydrate

（117）Cefmetazole Sodium （118）Cefmenoxime Hydrochloride

（119）Cefroxadine Hydrate （120）Cefuroxime Axetil

（121）Microcrystalline Cellulose （122）Powdered Cellulose

（123）Daunorubicin Hydrochloride （124）Talampicillin Hydrochloride

（125）Berberine Tannate （126）Teicoplanin

（127）Dexamethasone （128）Tetracycline Hydrochloride

（129）Demethylchlortetracycline Hydrochloride （130）Corn Starch

（131）Doxycycline Hydrochloride Hydrate （132）Doxorubicin Hydrochloride

（133）Tobramycin （134）Tranexamic Acid Capsules

（135）Tranexamic Acid Tablets （136）Trichomycin

（137）Trimetazidine Hydrochloride （138）Nystatin

（139）Nalidixic Acid （140）Nicotinamide

（141）Anhydrous Lactose （142）Lactose Hydrate

（143）Netilmicin Sulfate （144）Bacitracin

（145）Vasopressin Injection （146）Panipenem

（147）Calcium Para-aminosalicylate Hydrate （148）Calcium Para-aminosalicylate Granules

（149）Ethyl Parahydroxybenzoate （150）Butyl Parahydroxybenzoate

（151）Propyl Parahydroxybenzoate （152）Methyl Parahydroxybenzoate

（153）Haloperidol （154）Potato Starch

（155）Vancomycin Hydrochloride

（156）Insulin Human (Genetical Recombination)

（157）Pivmecillinam Hydrochloride

（158）Hydroxypropylmethylcellulose 2208

（159）Hydroxypropylmethylcellulose 2906 （160）Hydroxypropylmethylcellulose 2910

（161）Pimaricin （162）Pirarubicin

（163）Pyrrolnitrin （164）Famotidine Powder

（165）Famotidine Tablets （166）Faropenem Sodium Hydrate

（167）Phytonadione （168）Phenethicillin Potassium

（169）Bucillamine （170）Wine

（171）Fradiomycin Sulfate （172）Bleomycin Hydrochloride

（173）Bleomycin Sulfate

（174）Insulin Zinc Protamine Injection (Aqueous Suspension)

（175）Propranolol Hydrochloride （176）Flopropione Capsules

（177）Bromazepam

（178）Flomoxef Sodium

（179）Bekanamycin Sulfate （180）Bethanechol Chloride

（181）Betahistine Mesilate （182）Betamethasone

（183）Benidipine Hydrochloride Tablets （184）Peplomycin Sulfate

（185）Benzyl Alcohol （186）Benzylpenicillin Potassium

（187）Fosfomycin Sodium （188）Povidone

（189）Polymixin B Sulfate （190）Mitomycin C

（191）Micronomicin Sulfate （192）Midecamycin

（193）Midecamycin Acetate （194）Minocycline Hydrochloride

（195）Mupirocin Calcium Hydrate （196）Methylergometrine Maleate

（197）Methylergometrine Maleate Tablets

（198）Methylcellulose

（199）Metronidazole （200）Meropenem Hydrate

（201）Latamoxef Sodium （202）Rifampicin

（203）Ribostamycin Sulfate （204）Lincomycin Hydrochloride Hydrate

（205）Lenampicillin Hydrochloride （206）Roxithromycin

（207）Rokitamycin （208）Warfarin Potassium

（209）Foeniculated Ammonia Spirit （210）Powdered Fennel

（211）Astragalus Root （212）Scutellaria Root

（213）Powdered Scutellaria Root （214）Phellodendron Bark

（215）Powdered Phellodendron Bark （216）Coptis Rhizome

（217）Powdered Coptis Rhizome （218）Polygala Root

（219）Powdered Polygala Root （220）Pueraria Root

（221）Trichosanthes Root （222）Glycyrrhiza

（223）Powdered Glycyrrhiza （224）Platycodon Root

（225）Powdered Platycodon Root （226）Cinnamon Bark

（227）Powdered Cinnamon Bark （228）Safflower

（229）Red Ginseng （230）Achyranthes Root

（231）Burdock Fruit （232）Schisandra Fruit

（233）Bupleurum Root （234）Asiasarum Root

（235）Powdered Gardenia Fruit （236）Cornus Fruit

（237）Jujube Seed （238）Rehmannia Root

（239）Peony Root （240）Powdered Peony Root

（241）Plantago Seed （242）Amomum Seed

（243）Powdered Amomum Seed （244）Ginger

（245）Powdered Ginger （246）Senna Leaf

（247）Powdered Senna Leaf （248）Swertia Herb

（249）Atractylodes Lancea Rhizome

（250）Powdered Atractylodes Lancea Rhizome

（251）Perilla Herb （252）Rhubarb

（253）Powdered Rhubarb

（254）Jujube

（255）Alisma Rhizome （256）Powdered Alisma Rhizome

（257）Clove （258）Uncaria Hook

（259）Citrus Unshiu Peel （260）Japanese Angelica Root

（261）Powdered Japanese Angelica Root （262）Powdered Peach Kernel

（263）Ginseng （264）Powdered Ginseng

（265）Ophiopogon Tuber （266）Pinellia Tuber

（267）Loquat Leaf （268）Poria Sclerotium

（269）Powdered Poria Sclerotium （270）Processed Aconite Root

（271）Powdered Processed Aconite Root （272）Moutan Bark

（273）Powdered Moutan Bark （274）Hemp Fruit

（275）Akebia Stem

List 12

Quality Control of Water for Pharmaceutical Use, International Harmonization Implemented in the Japanese Pharmacopoeia Fifteenth Edition, Test for Trace Amounts of Aluminum in Trans Parenteral Nutrition (TPN) Solutions, Powder Flow, Laser Diffraction Measurement of Particle Size

List 13

Tablet Friability