Description of content The Seventeenth edition of the Japanese Pharmacopoeia (JP) shall be established as follows: 1. To establish 4 articles under the section of General Notices (List 1) 2. To amend 6 articles under the section of General Notices (List 2) 3. To amend 3 articles under the section of General Rules of Crude Drugs (List 3） 4. To establish 1 article under the section of General Rules of Preparations (List 4) 5. To amend 2 articles under the section of General Rules of Preparations (List 5) 6. To establish 5 test methods under the section of General Tests, Process and Apparatus (List 6) 7. To amend 18 test methods under the section of General Tests, Process and Apparatus (List 7) 8. To delete 1 test method under the section of General Tests, Process and Apparatus (List 8) 9. To establish 76 monographs under the section of Official Monographs (List 9) 10. To amend 472 monographs under the section of Official Monographs (List 10) 11. To delete 10 monographs under the section of Official Monographs (List 11) 12. To establish 21 spectra under the section of Infrared Reference Spectra (List 12) 13. To amend 2 spectra under the section of Infrared Reference Spectra (List 13) 14. To delete 3 spectra under the section of Infrared Reference Spectra (List 14) 15. To establish 14 spectra under the section of Ultraviolet-visible Reference Spectra (List 15) 16. To delete 2 spectra under the section of Ultraviolet-visible Reference Spectra (List 16) 17. To establish 11 paragraphs under the section of General Information (List 17) 18. To amend 9 paragraphs under the section of General Information (List 18) 19. To delete 2 paragraphs under the section of General Information (List 19) Established articles are listed with the planning numbers in JP seventeenth edition (JP17). Amended or deleted articles are listed with the numbers in JP sixteenth edition (JP16). The names of articles in English may change through the process of official English translation of JP17. List 1 12 Article of important matters in manufacturing process 34 Article of residual solvents 35 Article of toxic substances mixed intentionally 40 Article of definitions of asepsis, sterilization and aseptic manipulation List 2 1, 2, 5, 11, 33, 44 of JP16 List 3 1, 4, 5 of JP16 List 4 [2] General notices for Preparation packaging List 5 Following articles of General Rules of Preparations of JP16 [1] General Notices for Preparations [2] Monographs for Preparations 3．1． Injections 4．1． Dialysis Agents 6．1． Ophthalmic Preparations 7．1． Ear Preparations 11．7． Patches 11．7．1．Tapes/Plasters List 6 (1) 2.64 Glycosylation analysis of (2) 2.65 Degree of coloration of liquids Glycoprotein test (3) 3.05 Determination of (4) 6.12 Methods of adhesion testing sorption-desorption isotherms and of water activity (5) 6.13 Methods of drug release testing for preparations for cutaneous application List 7 Following test methods of General Tests, Process and Apparatus of JP16 (1) 2.21 Nuclear Magnetic (2) 2.46 Residual Solvents Test Resonance Spectroscopy (3) 2.49 Optical Rotation (4) 2.52 Thermal Analysis Determination (5) 2.60 Melting Point Determination (6) 3.01 Determination of Bulk and Tapped Densities (7) 5.01 Crude Drugs Test (8) 5.02 Microbial Limit Test for Crude Drugs (9) 6.02 Uniformity of Dosage Units (10) 6.05 Test for Extractable Volume of Parenteral Preparations (11) 6.06 Foreign Insoluble Matter (12) 9.01 Reference Standards Test for Injections (13) 9.21 Standard Solutions for (14) 9.22 Standard Solutions Volumetric Analysis (15) 9.23 Matching Fluids for Color (16) 9.41 Reagents, Test Solutions (17) 9.42 Solid Supports/Column (18) 9.44 Standard Particles, etc. Packings for Chromatography List 8 Following test method of General Tests, Process and Apparatus of JP16 (1) 8.01 Sterilization and Aseptic Manipulation List 9 (1) Ascorbic Acid and Calcium (2) Ampicillin Sodium-Sulbactam Sodium Pantothenate Tablets for Injection (3) Ampiroxicam (4) Ampiroxicam Capsules (5) Ethyl Icosapentate Capsules (6) Isomalt Hydrate (7) Irbesartan (8) Interferon Alfa (NAMALWA) (9) Interferon Alfa (NAMALWA) Injection (10) Eplerenone (11) Eplerenone Tablets (12) Ozagrel Sodium Injection (13) Hypromellose Capsules (14) Pullulan Capsules (15) L-Carbocisteine Tablets (16) Candesartan Cilexetil and Hydrochlorothiazide Tablets (17) Citicoline (18) Ciprofloxacin (19) Ciprofloxacin Hydrochloride Hydrate (20) Diflorasone Diacetate (21) Diltiazem Hydrochloride (22) Cilnidipine Extended-release Capsules (23) Cilnidipine Tablets (24) Silodosin (25) Silodosin Tablets (26) Spectinomycin Hydrochloride for Injection (27) Sultamicillin Tosilate Tablets (28) Cefalexin Combination Granules (29) Cefoperazone Sodium-Sulbactam (30) Cefpodoxime Proxetil for Syrup Sodium for Injection (31) Tacrolimus Capsules (32) Ticlopidine Hydrochloride Tablets (33) Tulobuterol (34) Tulobuterol Transdermal Tapes (35) Teprenone Capsules (36) Terbinafine Hydrochloride Tablets (37) Doxycycline Hydrochloride Tablets (38) Trientine Hydrochloride (39) Trientine Hydrochloride Capsules (40) Sodium L-Lactate Ringer´s Solution (41) Panipenem and Betamipron for (42) Valaciclovir Hydrochloride Injection (43) Valaciclovir Hydrochloride Tablets (44) Haloperidol Injection (45) Purified Sodium Hyaluronate Injection (46) Purified Sodium Hyaluronate Ophthalmic Solution (47) Pioglitazone Hydrochloride and (48) Felbinac Tape Glimepiride Tablets (49) Felbinac Cataplasm (50) Fluconazole Injection (51) Fosfomycin Calcium for Syrup (52) Voriconazole (53) Voriconazole Tablets (54) Miglitol (55) Mitiglinide Calcium Hydrate (56) Mitiglinide Calcium Tablets (57) Medroxyprogesterone (58) Acetate Montelukast Sodium (59) Montelukast Sodium Tablets (60) Montelukast Sodium Chewable Tablets (61) Lansoprazole (62) Lansoprazole Delayed-Release Orally Disintegration Tablets (63) Lansoprazole Delayed-release (64) Ribavirin Capsules (65) Ribavirin Capsules (66) Levofloxacin Injection (67) Kamikihito Extract (68) Hedysarum Root (69) Salvia Miltiorrhiza Root (70) Tokakujokito Extract (71) Codonopsis Root (72) Boiogito Extract (73) Sodium Sulfate Hydrate (74) Anhydrous Sodium Sulfate (75) Bofutsushosan Extract (76) Yokukansan Extract List 10 Following monographs of Official Monographs of JP16 (1) Azathioprine Tablets (2) Aciclovir (3) Azithromycin Hydrate (4) Acetylcysteine (5) Azelnidipine (6) Atorvastatin Calcium Hydrate (7) Atropine Sulfate Hydrate (8) Arsenical Paste (9) Aprindine Hydrochloride (10) Amiodarone Hydrochloride (11) Amiodarone Hydrochloride Tablets (12) Aminophylline Hydrate (13) Aminophylline Injection (14) Amphotericin B Tablets (15) Amphotericin B for Injection (16) Amlodipine Besilate (17) Alacepril Tablets (18) Argatroban Hydrate (19) Aldioxa Tablets (20) Alprostadil Injection (21) Arbekacin Sulfate (22) Alendronate Sodium Hydrate (23) Alendronate Sodium Tablets (24) Allopurinol Tablets (25) Ampicillin Sodium (26) Amlexanox Tablets (27) Iohexol (28) Idarubicin Hydrochloride (29) Isosorbide Mononitrate 70% / Lactose (30) Ibuprofen Piconol 30% (31) Ipratropium Bromide Hydrate (32) Ipriflavone (33) Imidapril Hydrochloride (34) Imipenem and Cilastatin Sodium for Injection (35) Irsogladine Maleate (36) Insulin Human (Genetical Recombination) (37) Insulin Human (Genetical (38) Insulin Glargine (Genetical Recombination) Injection Recombination) (39) Insulin Glargine (Genetical (40) Indapamide Recombination) Injection (41) Indenolol Hydrochloride (42) Ursodeoxycholic Acid Tablets (43) Ecabet Sodium Hydrate (44) Ecothiopate Iodide (45) Estradiol Benzoate Injection (Aqueous (46) Estriol Injection (Aqueous Suspension) Suspension) (47) Ethanol (48) Anhydrous Ethanol (49) Ethanol for Disinfection (50) Edaravone (51) Ethambutol Hydrochloride (52) Ethylmorphine Hydrochloride Hydrate (53) Edrophonium Chloride (54) Edrophonium Chloride Injection (55) Enoxacin Hydrate (56) Ebastine (57) Epalrestat (58) Epalrestat Tablets (59) Epoetin Alfa (Genetical (60) Epoetin Beta (Genetical Recombination) Recombination) (61) Emedastine Fumarate (62) Erythromycin Delayed-Release Tablets (63) Sodium Chloride (64) Enviomycin Sulfate (65) Oxycodone Hydrochloride Hydrate (66) Compound Oxycodone Injection (67) Compound Oxycodone and Atropine (68) Ozagrel Sodium for Injection Injection (69) Omeprazole (70) Omeprazole Delayed-Release Tablets (71) Auranofin (72) Olmesartan Medoxomil (73) Olopatadine Hydrochloride (74) Cadralazine (75) Capsules (76) Gabexate Mesilate (77) Calcitonin Salmon (78) Carvedilol (79) Carboplatin (80) Candesartan Cilexetil (81) dl-Camphor (82) Kitasamycin Tartrate (83) Quinapril Hydrochloride (84) Quinidine Sulfate Hydrate (85) Quinine Ethyl Carbonate (86) Quinine Hydrochloride Hydrate (87) Quinine Sulfate Hydrate (88) Sodium Aurothiomalate (89) Guanethidine Sulfate (90) Potassium Guaiacolsulfonate (91) Quetiapine Fumarate (92) Quetiapine Fumarate Tablets (93) Clarithromycin Tablets (94) Gliclazide (95) Glimepiride (96) Clebopride Malate (97) Clocapramine Hydrochloride Hydrate (98) Cloxacillin Sodium Hydrate (99) Clopidogrel Sulfate (100) Clopidogrel Sulfate Tablets (101) Clomifene Citrate (102) Chloramphenicol Sodium Succinate (103) Chloramphenicol Palmitate (104) Chlorphenesin Carbamate Tablets (105) Ketoconazole (106) Gefarnate (107) Gentamicin Sulfate (108) Codeine Phosphate Hydrate (109) Gonadorelin Acetate (110) Colistin Sodium Methanesulfonate (111) Colistin Sulfate (112) Colestimide (113) Saccharin (114) Zaltoprofen Tablets (115) Sarpogrelate Hydrochloride (116) Sarpogrelate Hydrochloride Tablets (117) Arsenic Trioxide (118) Cyanocobalamin (119) Diethylcarbamazine