Description of contentF 
 The Eighteenth edition of the Japanese Pharmacopoeia (JP) is to be partially 
amended as follows: 
 
 
1. To establish 3 item under the section of General Tests, Processes and Apparatus  
(List 1) 
 
2. To amend 8 items under the section of General Tests, Processes 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 JP18 
(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 JP18 
(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 JP18 
(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 qG1-4-181r (2) Control Strategies and Change 
Control Concepts at Each Stage of 
Chromatography Lifecycle  
(Change Control in Chromatography 
Lifecycle) qG1-5-181r 
(3) Measurement of powder flow 
properties by shear cell methodsqG2-
5-181r (4) Biorisk Management of the Handling 
of Microorganisms in Microbial Tests
qG4-11-181r 
(5) Functionality-related Characteristics of 
Excipients Relevant to Preparations
qG9-1-181r   
 
List 9  Following paragraphs of General Information of JP18 
(1) Concept on Impurities in 
Chemically synthesized Drug 
Substances and Drug Products 
qG0-3-181r (2) System SuitabilityqG1-2-181r 
(3) On the Scientific Names of Crude 
Drugs listed in the JPqG5-1-181r (4) Tablet Friability TestqG6-5-181r 
(5) Quality Control of Water for 
Pharmaceutical UseqGZ-2-181r   
 
List 10  Following paragraphs of General Information of JP18 (1) Near Infrared Spectrometry 
qG1-3-161r