Description of content ： 
 The Eigh teenth edition of the Japanese Pharmacopoeia  (JP) shall be established as 
follows :  
  
1. To establish  1 paragraph  under the section of General Notices (List  1) 
 
2. To amend  1 paragraph  under the section  of General Notices   (List 2 ) 
 
3. To establish  1 item under the section of General Tests, Process es and Apparatus   
(List 3 ) 
 
4. To amend  11 items  under the section of General Tests, Process es and Apparatus  
(List 4) 
 
5. To establish 33 monographs under the section of Official Monographs   (List 5) 
 
6. To amend 168 monographs under the section of Official Monographs   (List 6) 
 
7. To delete 8 monographs under the section of Official Monographs   (List 7) 
 
8. To establish 11  spectra under the section of Ultraviolet -visible  Reference Spectra   
(List 8) 
 
9. To establish 13 spectra  under the section of Infrared Reference Spectra  (List 9) 
 
10. To establish 7  paragraphs under the section of General Information   (List 10) 
 
11. To amend 3  paragraphs under the section of General Information   (List 11) 
 
12. To delete 1 paragraph under the section  of General Information  (List 12) 
 
 
 
   Established articles are listed with the planning numbers in the JP Eighteenth edition  
(JP18). 
 Amended or deleted articles are listed with the numbers in the JP Seventeenth edition 
(JP17).  
 The names of articles in English may change through the process of official English 
translation of JP18.  
 
List 1 34 Paragraph  of elemental impurities   
 
List 2 Following  paragraphs  of General Notices  of JP17  
8 
 
 
List 3   
2.05 Size Exclusion Chromatography  
 
List 4  Following  items  of General Tests, Processes and Apparatus  of JP17  
(1) Preface  (2) 2.46  Residual Solvents  
(3) 2.48  Water Determination (Karl 
Fischer  Method)  (4) 2.51  Conductivity Measurement  
(5) 2.52  Thermal Analysis  (6) 2.66  Elemental Impurities  
(7) 4.06  Sterility Test  (8) 5.01  Crude Drugs Test  
(9) 9.01  Reference Standards  (10) 9.41  Reagents, Test Solutions  
(11) 9.62  Measuring Instruments, 
Appliances    
 
List 5   
(1) Irinotecan Hydrochloride Injection  (2) Eribulin Mesilate  
(3) Cabergoline  (4) Glucagon (Genetical Recombination)  
(5) Cloperastine Fendizoate  (6) Cloperastine Fendizoate Tablets  
(7) Gefitinib  (8) Copovidone  
(9) Silodosin Orally Disintegrating Tablets  (10) Celecoxib  
(11) Zopiclone  (12) Zopiclone Tablets  
(13) Telmisartan and Amlodipine Besilate 
Tablets  (14) Triazolam  (15) Dorzolamide Hydrochloride and 
Timolol Maleate Ophthalmic Solution  (16) Bicalutamide  
(17) Pitavastatin Calcium Orally 
Disintegrating Tablets  (18) Phenobarbital Tablets  
(19) Fenofibrate  (20) Fenofibrate Tablets  
(21) Fludiazepam Tablets  (22) Heparin Sodium  Solution for Dialysis  
(23) Heparin Sodium Lock Solution  (24) Miglitol Tablets  
(25) Methotrexate for Injection  (26) Rilmazafone Hydrochloride Hydrate  
(27) Rilmazafone Hydrochloride Tablets  (28) Rosuvastatin Calcium  
(29) Rosuvastatin Calcium Tablets  (30) Ethyl Loflazepate  
(31) Ethyl Loflazepate Tablets  (32) Unseiin Extract  
(33) Byakkokaninjinto Extract    
 
 
List 6  Following monographs of Official Monographs of JP17  
(1) Azathioprine Tablets  (2) Aprindine Hydrochloride  
(3) Ethyl Aminobenzoate  (4) Insulin Human  
(Genetical Recombination)  
(5) Insulin Aspart  
(Genetical Recombination)  (6) Insulin Glargine  
(Genetical  Recombination)  
(7) Ethambutol Hydrochloride  (8) Epoetin Alfa  
(Genetical Recombination)  
(9) Epoetin Beta  
(Genetical Recombination)  (10) Ergometrine Maleate  
(11) Enviomycin Sulfate  (12) Oxytocin  
(13) Oxybuprocaine Hydrochloride  (14) Olmesartan Medoxomil  
(15) Kallidinogenase  (16) Calcitonin Salmon  
(17) Carmellose Calcium  (18) Carmellose Sodium  
(19) Croscarmellose Sodium  (20) Kitasamycin  Acetate  
(21) Kitasamycin Tartrate  (22) Clinofibrate  
(23) Clopidogrel Sulfate  (24) Gentamicin Sulfate  
(25) Colistin Sodium Methanesulfonate  (26) Saccharin  
(27) Saccharin Sodium Hydrate  (28) Oxygen  
(29) Distigmine Bromide  (30) Dihydroergotoxine Mesilate  
(31) Diphenhydramine  (32) Diphenhydramine Hydrochloride  
(33) Dimorpholamine  (34) Silodosin  (35) Silodosin Tablets  (36) Scopolamine Hydrobromide  
Hydrate  
(37) HumanMenopausal Gonadotrophin  (38) Cefoperazone Sodium  
(39) Gelatin  (40) Purified Gelatin  
(41) Purified Shellac  (42) White Shellac  
(43) Celmoleukin (Genetical  
Recombination)  (44) Teceleukin (Genetical  
Recombination)  
(45) Tetracaine Hydrochloride  (46) Wheat Starch  
(47) Dorzolamide Hydrochloride  (48) Nafamostat Mesilate  
(49) Nartograstim (Genetical  
Recombination)  (50) Anhydrous Lactose  
(51) Lactose Hydrate  (52) Norgestrel and Ethinylestradiol  
Tablets  
(53) Sucrose  (54) Vasopressin Injection  
(55) Calcium Paraaminosalicylate  
Hydrate  (56) Valaciclovir Hydrochloride  
(57) Valsartan  (58) Paroxetine Hydrochloride Hydrate  
(59) Pitavastatin Calcium Hydrate  (60) Pitavastatin Calcium Tablets  
(61) Low Substituted  
Hydroxypropylcellulose  (62) Hypromellose  
(63) Filgrastim  
(Genetical Recombination)  (64) Scopolamine Butylbromide  
(65) Glucose Injection  (66) Fradiomycin Sulfate  
(67) Pullulan  (68) Bleomycin Hydrochloride  
(69) Bleomycin Sulfate  (70) Protamine Sulfate  
(71) Heparin Calcium  (72) Heparin Sodium  
(73) Bepotastine Besilate  (74) Povidone  
(75) Povidone -Iodine  (76) Voriconazole  
(77) Voriconazole for Injection  (78) Calcium Folinate  
(79) Polymixin B Sulfate  (80) Mexiletine Hydrochloride  
(81) Methylergometrine Maleate  (82) Methylcellulose  
(83) Montelukast Sodium  (84) Sodium Lauryl Sulfate  
(85) Lauromacrogol  (86) Lysozyme Hydrochloride  
(87) Lenograstim (Genetical  
Recombination)  (88) Levofloxacin Hydrate  
(89) Levofloxacin Tablets  (90) Levofloxacin Fine Granules  
(91) Levofloxacin Injection  (92) Bearberry Leaf  (93) Phellodendron Bark  (94) Powdered Phellodendron Bark 
(95) Coptis Rhizome  (96) Powdered Coptis Rhizome  
(97) Orengedokuto Extract  (98) Zedoary  
(99) Pogostemon Herb  (100)  Pueraria Root  
(101)  Kamikihito Extract  (102)  Kamishoyosan Extract  
(103)  Trichosanthes Root  (104)  Glycyrrhiza  
(105)  Notopterygium  (106)  Lycium Fruit  
(107)  Sophora Root  (108)  Powdered Sophora Root  
(109)  Keishibukuryogan Extract  (110)  Cinnamon Bark  
(111)  Cinnamon Oil  (112)  Magnolia Bark  
(113)  Powdered Magnolia Bark  (114)  Euodia Fruit  
(115)  Goshuyuto Extract  (116)  Goreisan Extract  
(117)  Bupleurum Root  (118)  Asiasarum Root  
(119)  Saffron  (120)  Gardenia Fruit  
(121)  Powdered Gardenia Fruit  (122)  Cornus Fruit  
(123)  Japanese Zanthoxylum Peel  (124)  Powdered Japanese Zanthoxylum  
Peel 
(125)  Jujube Seed  (126)  Dioscorea Rhizome  
(127)  Plantago Seed  (128)  Plantago Herb  
(129)  Houttuynia Herb  (130)  Cardamon  
(131)  Cnidium Rhizome  (132)  Powdered Cnidium Rhizome  
(133)  Peucedanum Root  (134)  Nuphar Rhizome  
(135)  Toad Cake  (136)  Atractylodes Lancea Rhizome  
(137)  Sappan Wood  (138)  Perilla Herb  
(139)  Salvia Miltiorrhiza Root  (140)  Clove  
(141)  Powdered Clove  (142)  Uncaria Hook  
(143)  Polyporus Sclerotium  (144)  Powdered Polyporus Sclerotium  
(145)  Asparagus Root  (146)  Tokakujokito Extract  
(147)  Ipecac Syrup  (148)  Nutmeg  
(149)  Mentha Oil  (150)  Hangekobokuto Extract  
(151)  Lilium Bulb  (152)  Poria Sclerotium  
(153)  Powdered Poria Sclerotium  (154)  Belladonna Root  
(155)  Imperata Rhizome  (156)  Quercus Bark  
(157)  Moutan Bark  (158)  Powdered Moutan Bark  
(159)  Nux Vomica  (160)  Nux Vomica Extract  Powder  
(161)  Ephedra Herb  (162)  Powdered Japanese Gentian  
(163)  Alpinia Officinarum Rhizome  (164)  Ryokeijutsukanto Extract  (165)  Nelumbo Seed  (166)  Scopolia Rhizome  
(167)  Scopolia Extract Powder  (168)  Scopolia Extract and Ethyl  
Aminobenzoate Powder  
 
List 7  Following monographs of Official Monographs of JP17  
(1) Gas Gangrene Antitoxin, Equine  (2) Cholera Vaccine  
(3) Diphtheria -Tetanus Combined  
Toxoid  (4) Japanese Encephalitis Vaccine  
(5) Freeze -dried Japanese Encephalitis  
Vaccine  (6) Live Oral Poliomyelitis Vaccine  
(7) Methylrosanilinium Chloride  (8) Weil's Disease and Akiyami  
Combined Vaccine  
 
List 8  
(1) Cabergoline  (2) Cloperastine Fendizoate  
(3) Gefitinib  (4) Celecoxib  
(5) Zopiclone  (6) Triazolam  
(7) Bicalutamide  (8) Fenofibrate  
(9) Rilmazafone Hydrochloride  Hydrate  (10) Rosuvastatin Calcium  
(11) Ethyl Loflazepate  
 
List 9  
(1) Cabergoline  (2) Cloperastine Fendizoate  
(3) Gefitinib  (4) Copovidone  
(5) Celecoxib  (6) Zopiclone  
(7) Triazolam  (8) Bicalutamide  
(9) Fenofibrate  (10) Sodium Lauryl Sulfate  
(11) Rilmazafone Hydrochloride  Hydrate  (12) Rosuvastatin Calcium  
(13) Ethyl Loflazepate  
 
List 10 
(1) A Basic Concept of  the Quality 
Assurance on Biotechnological 
Products ( Biopharmaceuticals) 〈G3-
1-180〉 (2) Control of Culture Media and Strains 
of Microorganisms U sed for Microbial 
Test Methods 〈G4-2-180〉 
(3) Bacterial Endotoxins Test and 
Alternative Methods Using (4) Radioactivity Measurements Method 
for Crude Drugs 〈G5-8-180〉 Recombinant Protein -Reagents for 
Endotoxin Assay〈G4-4-180〉 
(5) Tablet Hardness Determinations 〈G6-
4-180〉 (6) Packaging Integrity Evaluation of 
Sterile Products 〈G7-4-180〉 
(7) Leak Tests for Packaging of Sterile 
Products 〈G7-5-180〉   
 
List 11  Following paragraphs  of General Information of JP17  
(1) Capillary Electrophoresis 〈G3-7-
180〉 (2) On the Scientific Names of Crude  
Drugs listed in the JP 〈G5-1-180〉 
(3) International Harmonization  
Implemented in the Japanese  
Pharmacopoeia Seventeenth Edition
〈GZ-3-180〉   
 
List 12  Following paragraphs  of General Information of JP17  
(1) Control of Elemental Impurities in  
Drug Products