Description of content ： 
 The Eigh teenth edition of the Japanese Pharmacopoeia  (JP) is to be partially 
amended as follows : 
 
 
1. To establish  3 item under the section of General Tests, Process es and Apparatus   
(List 1) 
 
2. To amend  8 items  under the section of General Tests, Process es and Apparatus  
(List 2) 
 
3. To establish 11 monographs under the section of Official Monographs   (List 3) 
 
4. To amend 82 monographs under the section of Official Monographs   (List 4) 
 
5. To delete 2 monographs under the section of Official Monographs   (List 5) 
 
6. To establish 4 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 establish 5 paragraphs under the section of General Information   (List 8) 
 
9. To amend 5 paragraphs under the section of General Information   (List 9) 
 
10. To delete 1 paragraph under the section  of General Information  (List 10) 
 
 
 
   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 Eighteenth  edition 
(JP18). 
 The names of articles in English may change through the process of official English 
translation of JP18 -1. 
 
List 1   
(1) 2.00  Chromatography  (2) 2.27  Near Infrared Spectrometry  
(3) 2.28  Circular Dichroism Spectroscopy    
 
List 2  Following items  of General Tests, Processes and Apparatus  of JP1 8 
(1) 2.01  Liquid Chromatography  (2) 2.02  Gas Chromatography  
(3) 2.22  Fluorometry  (4) 2.58  X-Ray Powder Diffraction  
Method  
(5) 3.04  Particle Size Determination  (6) 9.01  Reference Standards  
(7) 9.41  Reagents, Test Solutions  (8) 9.42  Solid Supports/Column  
Packings for Chromatography  
 
List 3   
(1) Anastrozole  (2) Anastrozole Tablets  
(3) Oxybutynin Hydrochloride  (4) Temozolomide  
(5) Temozolomide Capsules  (6) Temozolomide for Injection  
(7) Bicalutamide Tablets  (8) Budesonide  
(9) Voglibose Orally Disintegrating Tablets  (10) Saikokeishikankyoto Extract  
(11) Yokukansankachimpihange Extract    
 
List 4  Following monographs of Official Monographs of JP 18 
(1) Amphotericin B Tablets  (2) Amphotericin B for Injection  
(3) Ampicillin Sodium and Sulbactam  
Sodium for Injection  (4) Imipenem and Cilastatin Sodium for 
Injection  
(5) Insulin Human  
(Genetical Recombination)  (6) Insulin Human (Genetical  
Recombination) Injection  
(7) Isophane Insulin Human (Genetical  
Recombination) Injectable Aqueous  
Suspension  (8) Biphasic Isophane Insulin Human  
(Genetical Recombination)  
Injectable Aqueous Suspension  
(9) Ethanol  (10) Anhydrous Ethanol  
(11) Epoetin Beta  
(Genetical Recombination)  (12) Sodium Chloride  (13) Enviomycin Sulfate  (14) Croscarmellose Sodium  
(15) Sarpogrelate Hydrochloride Fine  
Granules  (16) Stearic Acid  
(17) Magnesium Stearate  (18) Spectinomycin Hydrochloride for  
Injection  
(19) Cefoperazone Sodium and  
Sulbactam Sodium for Injection  (20) Powdered Cellulose  
(21) Wheat Starch  (22) Ethyl Parahydroxybenzoate  
(23) Butyl Parahydroxybenzoate  (24) Propyl Parahydroxybenzoate  
(25) Methyl Parahydroxybenzoate  (26) Hypromellose Phthalate  
(27) Butropium Bromide  (28) Bromhexine Hydrochloride  
(29) Benzyl Alcohol  (30) Voglibose Tablets  
(31) Polysorbate 80  (32) Formoterol Fumarate Hydrate  
(33) D-Mannitol  (34) dl-Menthol  
(35) l－Menthol  (36) Glyceryl Monostearate  
(37) Yellow Petrolatum  (38) White Petrolatum  
(39) Artemisia Capillaris Flower  (40) Ipecac  
(41) Bearberry Leaf  (42) Corydalis Tuber  
(43) Powdered Corydalis Tuber  (44) Artemisia Leaf  
(45) Processed Ginger  (46) Apricot Kernel  
(47) Keishibukuryogan Extract  (48) Magnolia Bark  
(49) Achyranthes Root  (50) Goshajinkigan Extract  
(51) Goshuyuto Extract  (52) Burdock Fruit  
(53) Gardenia Fruit  (54) Cornus Fruit  
(55) Prepared Glycyrrhiza  (56) Cnidium Monnieri Fruit  
(57) Plantago Herb  (58) Ginger  
(59) Powdered Ginger  (60) Cardamon  
(61) Cimicifuga Rhizome  (62) Shimbuto Extract  
(63) Senna Leaf  (64) Powdered Senna Leaf  
(65) Mukoi -Daikenchuto Extract  (66) Clove  
(67) Clove Oil  (68) Uncaria Hook  
(69) Tokakujokito Extract  (70) Peach Kernel  
(71) Powdered Peach Kernel  (72) Picrasma Wood  
(73) Powdered Picrasma Wood  (74) Nutmeg  
(75) Hachimijiogan Extract  (76) Glehnia Root and Rhizome  
(77) Hangekobokuto Extract  (78) Sinomenium Stem and Rhizome  
(79) Maoto Extract  (80) Akebia Stem  
(81) Bitter Cardamon  (82) Leonurus Herb   
List 5  Following monographs of Official Monographs of JP1 8 
(1) Nartograstim (Genetical  
Recombination)  (2) Nartograstim for Injection  
(Genetical Recombination)  
 
List 6  
(1) Anastrozole  (2) Oxybutynin Hydrochloride  
(3) Temozolomide  (4) Budesonide  
 
List 7  
(1) Anastrozole  (2) Oxybutynin Hydrochloride  
(3) Croscarmellose Sodium  (4) Temozolomide  
(5) Budesonide  (6) Yellow Petrolatum  
(7) White Petrolatum    
 
List 8 
(1) Instrumental Measurement of 
Coloration of Liquids 〈G1-4-181〉 (2) Control Strategies and Change 
Control Concepts at Each Stage of 
Chromatography Lifecycle  
(Change Control in Chromatography 
Lifecycle) 〈G1-5-181〉 
(3) Measurement of powder flow 
properties by shear cell methods 〈G2-
5-181〉 (4) Biorisk Management of the Handling 
of Microorganisms in Microbial Tests
〈G4-11-181〉 
(5) Functionality -related Characteris tics of 
Excipients Relevant to Preparations
〈G9-1-181〉   
 
List 9  Following paragraphs of General Information of JP1 8 
(1) Concept on Impurities in  
Chemically synthesized Drug  
Substances and Drug Products  
〈G0-3-181〉 (2) System Suitability 〈G1-2-181〉 
(3) On the Scientific Names of Crude  
Drugs listed in the JP 〈G5-1-181〉 (4) Tablet Friability Test 〈G6-5-181〉 
(5) Quality Control of Water for  
Pharmaceutical Use 〈GZ-2-181〉   
 
List 10  Following paragraphs of General Information of JP1 8 (1) Near Infrared Spectrometry  
〈G1-3-161〉