Partial revision of the Japanese Pharmacopoeia, Seventeenth edition  
 
Description of content ： 
 The Seventeenth edition of  the Japanese Pharmacopoeia (JP) is to be partially 
amended as follows:  
  
1. To establish 2 article under the section of General Rules of Preparations (List 1) 
 2. To amend 6 article under the section of General Rules of Preparations (List 2) 
 3. To establish 3 test methods under th e section of General Tests, Process and 
Apparatus (List 3) 
 4. To amend 9 test met hods under the section of General Tests, Process and 
Apparatus (List 4) 
 
5. To establish 32 monographs under the se ction of Official Monographs (List 5) 
 6. To amend 114 monographs under the sect ion of Official Monographs (List 6) 
 7. To delete 17 monographs under the sect ion of Official Monographs (List 7) 
 8. To establish 10 spectra under the section of Ultraviolet-visible Reference Spectra 
(List 8) 
 9. To delete 5 spectra under the section of Ultraviolet-vis ible Reference Spectra (List 
9) 
 10. To establish 10 spectra under the secti on of Infrared Reference Spectra (List 10) 
 11. To delete 5 spectra under the section of Infrared Reference Spectra (List 11) 
 12. To establish 6 paragraphs under the sect ion of General Info rmation (List 12) 
 13. To amend 8 paragraphs under the secti on of General Information (List 13) 
 
14. To delete 1 paragraphs under the secti on of General Information (List 14) List 1  
[2] Monographs for Preparations 
1．8． Films for Oral Administration 
1．8．1  Orally Disintegrating Films/Orodispersible Films 
 
List 2  
[1] General Notices for Preparations [2] Monographs for Preparations 
5．1．1  Dry Powder Inhalers 
5．1．3 Metered-Dose Inhalers 
9．1． Suppositories for Rectal Application 
10．2． Suppositories for Vaginal Use 
11．2． Liquids and Solutions for Cutaneous Application 
 
List 3 
(1) 3.06   Laser Diffraction  
Measurement of Particle Size (2) 6.14   Uniformity of Delivered Dose for 
Inhalations 
(3) 6.15   Aerodynamic Particle Size 
Measurement for Inhalations   
 
List 4   
(1) 2.24  Ultraviolet-visible 
Spectrophotometry (2) 2.46  Residual Solvents 
(3) 4.03  Digestion Test (4) 6.02  Uniformity of Dosage Units 
(5) 6.04  Test for Acid-neutralizing 
Capacity  of Gastrointestinal 
Medicines (6) 9.01  Reference Standards 
(7) 9.21  Standard Solutions for 
Volumetric Analysis (8) 9.41  Reagents, Test Solutions 
(9) 9.42  Solid Supports/Column 
Packings for Chromatography   
 
List 5   
(1) Azosemide (2) Azosemide Tablets (3) Irbesartan Tablets (4) Irbesartan and Amlodipine Besilate 
Tablets 
(5) Isophane Insulin Human (Genetical (6) Biphasic Isophane Insulin Human Recombination) Injectable Aqueous 
Suspension (Genetical Recombination) Injectable 
Aqueous Suspension 
(7) Insulin Aspart 
 (Genetical Recombination) (8) Entacapone   
(9) Entacapone Tablets  (10) Clotiazepam Tablets 
(11) Clomipramine Hydrochloride Tablets (12) Chloramphenicol and Colistin Sodium 
Methanesulfonate Ophthalmic Solution
(13) Magnesium Aluminosilicate ( 14) Magnesium Aluminometasilicate 
(15) Cefoperazone Sodium for Injection (16) Zonisamide (17) Zonisamide Tablets (18) Tramadol Hydrochloride (19) Pazufloxacin Mesilate (20) Pazufloxacin Mesilate Injection (21) Pyridoxal Phosphate Hydrate (22) Purified Glucose (23) Glucose Hydrate (24) Pentobarbital Calcium Tablets  (25) Voriconazole for Injection (26) Mesalazine (27) Mesalazine Extended-release Tablets (28) Methotrexate Tablets (29) Montelukast Sodium Granules (30) Calcium Levofolinate Hydrate (31) Roxithromycin Tablets (32) Goreisan Extract 
 
 List 6  
(1) Amoxicillin Hydrate  (2) Ampicillin Hydrate  
(3) Iohexol Injection  (4) Isosorbide Mononitrate 70%/Lactose 
30% 
(5) Ethanol  (6) Anhydrous Ethanol  
(7) Edaravone Injection  (8) Epalrestat  
(9) Erythromycin  (10) Oxytetracycline Hydrochloride  
(11) Clarithromycin  (12) Cloxacillin Sodium Hydrate  
(13) Chloramphenicol Sodium Succinate  (14) Gentamicin Sulfate  
(15) Colistin Sodium Methanesulfonate  (16) Saccharin Sodium Hydrate  
(17) Digoxin  (18) Suxamethonium Chloride Injection  
(19) Spiramycin Acetate  (20) Sultamicillin Tosilate Hydrate  
(21) Sulbactam Sodium  (22) Cefixime Hydrate  
(23) Ceftizoxime Sodium (24) Cellacefate (25) Teicoplanin (26) Dextran 40 (27) Tetracycline Hydrochloride (28) Demethylchlortetracycline 
Hydrochloride 
(29) Doxycycline Hydrochloride Hydr ate (30) Doxorubicin Hydrochloride 
(31) Tobramycin (32) Thrombin (33) Anhydrous Lactose (34) Lactose Hydrate 
(35) Noradrenaline (36) Bacitracin (37) Vasopressin Injection (38) Hydroxypropylcellulose (39) Low Substituted 
Hydroxypropylcellulose (40) Hydroxocobalamin Acetate 
(41) Hydrocortisone Acetate (42) Hydrocortisone Butyrate 
(43) Hypromellose (44) Vincristine Sulfate (45) Vinblastine Sulfate (46) Glucose Injection (47) Heparin Calcium (48) Heparin Sodium (49) Verapamil Hydrochloride (50) Verapamil Hydrochloride Tablets 
(51) Benzylpenicillin Potassium (52) Pentobarbital Calcium (53) Fosfomycin Calcium Hydrate (54) Fosfomycin Sodium (55) Povidone (56) Polysorbate 80 (57) Polymixin B Sulfate (58)
D-Mannitol 
(59) Methylcellulose (60) Folic Acid  
(61) Sodium Lauryl Sulfate (62) Powdered Sweet Hydrangea Leaf (63) Artemisia Capillaris Flower (64) Turmeric (65) Powdered Turmeri (66) Orengedokuto Extract (67) Otsujito Extract (68) Curcuma Rhizome (69) Kakkonto Extract (70) Kakkontokasenkyushin’i Extract (71) Kamikihito Extract (72) Kamishoyosan Extract (73) Trichosanthes Root (74) Glycyrrhiza Extract (75) Crude Glycyrrhiza Extract (76) Platycodon Root (77) Keishibukuryogan Extract (78) Cyperus Rhizome (79) Powdered Cyperus Rhizome (80) Oriental Bezoar (81) Goshajinkigan Extract (82) Euodia Fruit (83) Saikokeishito Extract (84) Saibokuto Extract (85) Saireito Extract (86) Gardenia Fruit (87) Cornus Fruit (88) Jujube Seed (89) Shakuyakukanzoto Extract (90) Juzentaihoto Extract (91) Shosaikoto Extract (92) Shoseiryuto Extract (93) Shimbuto Extract (94) Daiokanzoto Extract (95) Mukoi-Daikenchuto Extract (96) Daisaikoto Extract (97) Jujube (98) Powdered Alisma Tuber (99) Chotosan Extract (100) Tokakujokito Extract 
(101) Tokishakuyakusan Extract (102) Rape Seed Oil (103) Bakumondoto Extract (104) Hachimijiogan Extract (105) Hangekobokuto Extract (106) Hangeshashinto Extract 
(107) Boiogito Extract (108) Saposhnikovia Root and Rhizome (109) Bofutsushosan Extract (110) Hochuekkito Extract 
(111) Maoto Extract (112) Yokukansan Extract 
(113) Rikkunshito Extract (114) Ryokeijutsukanto Extract 
 
 List 7  
(1) Aceglutamide Aluminum (2) Gramicidin (3) Digitoxin (4) Digitoxin Tablets (5) Diclofenamide (6) Diclofenamide Tablets (7) Zinostatin Stimalamer (8) Serrapeptase (9) Tolazamide (10) Fluoxymesterone 
(11) Mercurochrome (12) Mercurochrome Solution 
(13) Lanatoside C (14) Lanatoside C Tablets (15) Rokitamycin (16) Rokitamycin Tablets (17) Scopolia Extract, Papaverine and 
Ethyl Aminobenzoate Powder   
 
List 8  
(1) Azosemide (2) Entacapone (3) Sultamicillin Tosilate Hydrate (4) Zonisamide (5) Doxycycline Hydrochloride Hy drate (6) Tramadol Hydrochloride 
(7) Pazufloxacin Mesilate (8) Pyridoxal Phosphate Hydrate (9) Mesalazine (10) Calcium Levofolinate Hydrate 
    
List 9  
(1) Gramicidin (2) Diclofenamide (3) Tolazamide (4) Fluoxymesterone (5) Rokitamycin   
 List 10 
(1) Azosemide (2) Entacapone (3) Oxytetracycline Hydrochloride (4) Zonisamide (5) Tramadol Hydrochloride (6) Pazufloxacin Mesilate (7) Low Substituted 
Hydroxypropylcellulose (8) Pyridoxal Phosphate Hydrate 
(9) Mesalazine (10) Calcium Levofolinate Hydrate  
List 11 Following spectra of Infrared Reference Spectra of JP17 
(1) Saccharin Sodium Hydrate (2) Diclofenamide (3) Tolazamide (4) Fluoxymesterone (5) Rokitamycin   
 List 12 
(1) Enzyme-linked immunosorbent assay 
(ELISA) (2) Aerodynamic Assessment of Fine 
Particles for Inhalations by Glass Impingers 
(3) Glass Containers for Pharmaceutical 
Products (4) Moisture Permeability Test for Blister 
Packaging of Solid Preparations 
(5) Stability Testing of Drug Substance 
and Product (6) Criteria for Content Uniformity in Real 
Time Release Testing by Process Analytical Technology 
 List 13   
(1) Solid and Particle Densities (2) Powder Fineness (3) Powder Flow (4) 
Amino Acid Analysis 
(5) Purity Tests on Crude Drugs using 
Genetic Information  (6) On the Scientific Names of Crude Drugs 
listed in the JP 
(7) Basic Concepts for Quality Assurance 
of Drug Substances and Drug Products (8) International Harmonization 
Implemented in the Japanese Pharmacopoeia Seventeenth Edition 
 
List 14   Following paragraphs of General Information of JP17 
(1) Laser Diffraction Measurement of 
Particle Size