Description of content ： 
 The Eigh teenth edition of the Japanese Pharmacopoeia  (JP) is to be partially 
amended as follows : 
 
 
1. To establish  1 item under the section of General Tests, Process es and Apparatus   
(List 1) 
 
2. To amend  10 items  under the section of General Tests, Process es and Apparatus  
(List 2) 
 
3. To establish 13 monographs under the section of Official Monographs   (List 3) 
 
4. To amend 95 monographs under the section of Official Monographs   (List 4) 
 
5. To delete 7 monographs under the section of Official Monographs   (List 5) 
 
6. To establish 5 spectra under the section of Ultraviolet -visible  Reference Spectra   
(List 6) 
 
7. To establish 7 spectra  under the section of Infrared Reference Spectra  (List 7) 
 
8. To delete  1 spectra  under the section of Infrared Reference  Spectra (List 8)  
 
9. To establish 6 paragraphs under the section of General Information   (List 9) 
 
10. To amend 5 paragraphs under the section of General Information   (List 10) 
 
11. To delete 1 paragraph under the section  of General Information  (List 11) 
 
 
 
  ⚫ Established articles are listed with the planning numbers in Supplement Ⅱ to the JP 
Eighteenth edition  (JP18-2). 
⚫ Amended or deleted articles are listed with the numbers in the JP (previous 
Pharmacopoeia).  
⚫ The names of articles in English may change through the process of official English 
translation of JP18 -2. 
 
List 1   
(1) 3.07 Measurement of the Diameter of  Particles  Dispersed in Liquid  by Dynamic 
Light Scattering  
 
List 2  Following items  of General Tests, Processes and Apparatus  of previous 
Pharmacopoeia  
(1) 2.03 Thin -layer Chromatography  (2) 2.46 Residual Solvents  
(3) 2.66 Elemental Impurities  (4) 3.01 Determination of Bulk Densit y 
(5) 4.02 Microbial Assay for Antibiotics  (6) 5.01 Crude Drugs Test  
(7) 9.01 Reference Standards  (8) 9.41 Reagents, Test Solutions  
(9) 9.42 Solid Supports/Column  
Packings for Chromatography  (10) 9.62 Measuring Instruments, 
Appliances  
 
List 3   
(1) Aripiprazole  (2) Oxaliplatin  
(3) Oxaliplatin Injection  (4) Gefitinib Tablets  
(5) Goserelin Acetate  (6) Lithium Carbonate Tablets  
(7) Tolvaptan  (8) Tolvaptan tablets  
(9) Febuxostat  (10) Febuxostat Tablets  
(11) Lornoxicam  (12) Lornoxicam Tablets  
(13) Shin’iseihaito Extract    
 
List 4 Following monographs of Official Monographs of previous Pharmacopoeia  
(1) Sodium Bisulfite  (2) Dried Sodium Sulfite  
(3) Disodium Edetate Hydrate  (4) Carmellose Calcium  
(5) Glycerin  (6) Concentrated Glycerin  
(7) Clindamycin Phosphate  (8) Clonidine Hydrochloride  
(9) Light Anhydrous Silicic Acid  (10) Magnesium Silicate  
(11) Cyclophosphamide Hydrate  (12) Citicoline  (13) Calcium Stearate  (14) Polyoxyl 40 Stearate  
(15) Magnesium Stearate  (16) Sorbitan Sesquioleate  
(17) Talc (18) Dried Sodium Carbonate  
(19) Sodium Carbonate Hydrate  (20) Dextran 70  
(21) Teceleukin (Genetical  
Recombination)  (22) White Soft Sugar  
(23) Paraffin  (24) Liquid Paraffin  
(25) Light Liquid Paraffin  (26) Low Substituted 
Hydroxypropylcellulose  
(27) Hypromellose  (28) Sodium Pyrosulfite  
(29) Glucose  (30) Propylene Glycol  
(31) Beclometasone Dipropionate  (32) Sodium Polystyrene Sulfonate  
(33) Meglumine  (34) Methylcellulose  
(35) Aluminum Monostearate  (36) Sodium Iodide  
(37) Loxoprofen Sodium Hydrate  (38) Sweet Hydrangea Leaf  
(39) Artemisia Capillaris Flower  (40) Epimedium Herb  
(41) Lindera Root  (42) Bearberry Leaf  
(43) Polygonatum Rhizome  (44) Artemisia Leaf  
(45) Pogostemon Herb  (46) Pueraria Root  
(47) Chrysanthemum Flower  (48) Lycium Fruit  
(49) Gentian  (50) Powdered Gentian  
(51) Goshajinkigan Extract  (52) Schisandra Fruit  
(53) Cornus Fruit  (54) Rehmannia Root  
(55) Cardamon  (56) Hedysarum Root  
(57) Shimbuto Extract  (58) Senna Leaf  
(59) Sappan Wood  (60) Perilla Herb  
(61) Rhubarb  (62) Powdered Rhubarb  
(63) Jujube  (64) Salvia Miltiorrhiza Root  
(65) Uncaria Hook  (66) Citrus Unshiu Peel  
(67) Asparagus Root  (68) Tokishakuyakusan Extract  
(69) Codonopsis Root  (70) Nutmeg  
(71) Lonicera Leaf and Stem  (72) Ophiopogon Root  
(73) Hachimijiogan Extract  (74) Mentha Herb  
(75) Loquat Leaf  (76) Processed Aconite Root  
(77) Belladonna Extract  (78) Boiogito Extract  
(79) Quercus Bark  (80) Nux Vomica Extract  (81) Nux Vomica Extract Powder  (82) Nux Vomica Tincture  
(83) Digenea  (84) Akebia Stem  
(85) Leonurus Herb  (86) Coix Seed  
(87) Powdered Coix Seed  (88) Yokukansankachimpihange Extract  
(89) Nelumbo Seed  (90) Scopolia Extract  
(91) Scopolia Extract Powder  (92) Scopolia Extract and Ethyl 
Aminobenzoate Powder  
(93) Scopolia Extract and Carbon Powder  (94) Compound Scopolia Extract and 
Diastase Powder  
(95) Royal Jelly    
 
List 5 Following monographs of Official Monographs of  previous Pharmacopoeia  
(1) Amlexanox  (2) Amlexanox Tablets  
(3) Cefadroxil  (4) Cefadroxil Capsules  
(5) Cefadroxil for Syrup  (6) Tolbutamide  
(7) Tolbutamide Tablets    
 
List 6  
(1) Aripiprazole  (2) Oxaliplatin  
(3) Tolvaptan  (4) Febuxostat  
(5) Lornoxicam    
 
List 7  
(1) Aripiprazole  (2) Disodium Edetate Hydrate  
(3) Oxaliplatin  (4) Cyclophosphamide Hydrate  
(5) Tolvaptan  (6) Febuxostat  
(7) Lornoxicam    
 
List 8 Following spectra  of Infrared Reference  Spectra  of previous Pharmacopoeia  
(1) Clindamycin Phosphate  
 
List 9 
(1) Analyses of Size and Morphology of 
Nanoparticles by Atomic Force 
Microscope 〈G1-9-182〉 (2) Concept of Weighing in the 
Japanese Pharmacopoeia 〈G1-6-
182〉 
(3) Calibration, Inspection, and Weight of (4) Installation Environment, Basic a weighing instrument (balance) 
〈G1-7-182〉 Handling Method, and Precautions 
for Weighing of a Balance 〈G1-8-
182〉 
(5) Flow Cytometry 〈G3-16-182〉 (6) Evaluation Method of Insoluble 
Particulate Matter in Biotechnological 
Products (Biopharmaceuticals) Drug 
Substances/Drug Products by Flow 
Imaging Method 〈G3-17-182〉 
 
List 10 Following paragraphs of General Information of  previous Pharmacopoeia  
(1) Solid and Particle Densities 〈G2-1-
171〉 (2) Powder Flow 〈G2-3-171〉 
(3) Peptide Mapping 〈G3-3-142〉 (4) On the Scientific Names of Crude 
Drugs listed in the JP 〈G5-1-181〉 
(5) Thin-layer Chromatography for 
Crude Drugs and Crude Drug 
Preparations 〈G5-3-170〉   
 
List 11 Following paragraph of General Information of  previous Pharmacopoeia  
(1) Measurement of the Diameter of Particles Dispersed in Liquid by Dynamic Light 
Scattering 〈G2-4-161〉