Partial revision of the Japanese Pharmacopoeia, Sixteenth Edition  
 
The Japanese Pharmacopoeia, Sixteenth Edition is to be  partially amended as follows ： 
 
1. To amend article 23  under the section of Gene ral Notice  
 2. To amend art icle 1 under the section of General Rules for Crude Drugs  
 3. To amend article 2 under the section of General Rules of Preparation  
 4. To add 2.61 Turbidimetric  Test under the section of General Tests, Process and  
Apparatus  
 
5. To amend 7  test method s under the section of General Tests, Process and Apparatus
（For details to Annex 1） 
 
6. To add 60  monographs under the section of Monographs （For details to Annex 2） 
 7. To amend 173  monographs under the section of Monographs （For det ails to Annex 3） 
 8. To delete the provision of Thiotepa  under the section of Monographs  
 
9. To add the provision of Basic Requirements for Plastic Containers for Pharmaceutical 
Use and Rubber Closures for Containers for Aqueous Infusions under t he section of 
General Information  
 10. To amend 4  paragraphs under the section of General Information （For details to Annex 
4） 
 11. To delete the provision of Plastic Containers for Pharmaceutical Products  under the 
section of General Informati on 
  
 
 
 
 
 
1 Annex１ 
 
(1) 1.11 Arsenic Limit Test  (2) 2.25 Infrared Spectrophotometry  
(3) 5.01 Crude Drugs Test  (4) 6.02 Uniformity of Dosage Units  
(5) 6.06 Foreign Insoluble Matter Test for 
Injections  (6) 7.02 Test Methods for Plastic Containers  
(7) 7.03 Test for Rubber Closure for 
Aqueous Infusions    
 Annex  2 
 
(1) Aciclovir Granules  (2) Aciclovir Ophthalmic Ointment  
(3) Aciclovir Tablets  (4) Azelnidipine Tablets  
(5) Iopamidol Injection  (6) Ifenprodil Tartrate Fine Granules  
(7) Ifenprodil Tart rate Tablets  (8) Insulin Human (Genetical Recombination) Injection  
(9) Insulin Glargine (Genetical 
Recombination)  (10) Insulin Glargine (Genetical 
Recombination) Injection  
(11) Calcium Sodium Edetate Hydrate  (12) Olmesartan Medoxomil  
(13) Olmesartan Med oxomil Tablets  (14) Olopatadine Hydrochloride  
(15) Olopatadine Hydrochloride Tablets  (16) Candesartan Cilexetil and Amlodipine Besylate Tablets  
(17) Clonazepam Fine Granules  (18) Clonazepam Tablets  
(19) Clopidogrel Sulfate  (20) Clopidogrel Sulfate Table ts 
(21) Colestimide Granules  (22) Cyclophosphamide Tablets  
(23) Sivelestat Sodium Hydrate  (24) Sivelestat Sodium for Injection  
(25) Tacalcitol Ointment  (26) Tazobactam and Piperacillin for Injection  
(27) Telmisartan  (28) Telmisartan Tablets  
(29) Docet axel Hydrate  (30) Docetaxel Injection  
(31) Docetaxel for Injection  (32) Naftopidil  
(33) Naftopidil Tablets  (34) Naftopidil Orally Disintegrating Tablets  
(35) Paroxetine Hydrochloride Hydrate  (36) Paroxetine Hydrochloride Tablets  
(37) Pioglitazone Hydrochloride and 
Metformin Hydrochloride Tablets  (38) Pitavastatin Calcium Hydrate  
(39) Pitavastatin Calcium Tablets  (40) Pilsicainide Hydrochloride Hydrate  
2 (41) Pilsicainide Hydrochloride Capsules  (42) Fudosteine  
(43) Fudosteine Tablets  (44) Pranlukast Hyd rate 
(45) Fluconazole Capsules  (46) Brotizolam Tablets  
(47) Bepotastine Besilate  (48) Bepotastine Besilate Tablets  
(49) Mequitazine Tablets  (50) Mecobalamin Tablets  
(51) Leuprorelin Acetate  (52) Loxoprofen Sodium Tablets  
(53) Losartan Potassium and 
Hydrochlorothiazide Tablets  (54) Otsujito Extract  
(55) Kakkontokasenkyushin’i Extract  (56) Prepared Glycyrrhiza  
(57) Daisaikoto Extract  (58) Cistanche Herb  
(59) Belladonna Total Alkaloids  (60) Maoto Extract  
 
Annex  3 
 
(1) Alprostadil Alfadex  (2) Iohexol Injection  
(3) Irsogladine Maleate Fine Granules  (4) Insulin Human  
(Genetical Recombination)  
(5) Indometacin  (6) Ethanol  
(7) Anhydrous Ethanol  (8) Etizolam Fine Granules  
(9) Etizolam Tablets  (10) Epoetin Alfa  
(Genetical Recombination)  
(11) Calciton in (Salmon)  (12) Carmellose  
(13) Glycine  (14) Glycerin  
(15) Concentrated Glycerin  (16) L-Glutamic Acid  
(17) Chlordiazepoxide Powder  (18) Cortisone Acetate  
(19) Zaltoprofen Tablets  (20) Sarpogrelate Hydrochloride Fine  
Granules  
(21) Zidovudine  (22) Sterile Water for Injection in  
Containers  
(23) Dried Aluminum Hydroxide Gel  
Fine Granules  (24) Stearic Acid  
(25) Spiramycin Acetate  (26) Spironolactone  
(27) Cefaclor Fine Granules  (28) Cefotaxime Sodium  
(29) Cefcapene Pivoxil Hydrochloride  
Fine Granules  (30) Cefditoren Pivoxil Fine Granules  
(31) Cefdinir  (32) Cefdinir Fine Granules  
(33) Ceftazidime Hydrate  (34) Cefteram Pivoxil  
3 (35) Cefteram Pivoxil Fine Granules  (36) Cefpodoxime Proxetil  
(37) Cefmetazole Sodium  (38) Cefuroxime Axetil  
(39) Celmoleukin (Genetical  
Recombination)  (40) Daunorubicin Hydrochloride  
(41) Precipitated Calcium Carbonate  
Fine Granules  (42) Thiamine Chloride Hydrochloride  
(43) Tegafur  (44) Dexamethasone  
(45) Wheat Starch  (46) Rice Starch  
(47) Corn Starch  (48) Potato Starch  
(49) Donepezil Hydrochloride Fine  
Granules  (50) Dobutamine Hydrochloride  
(51) Triamcinolone  (52) Triamcinolone Acetonide  
(53) Droxidopa Fine Granules  (54) Troxipide Fine Granules  
(55) Droperidol  (56) Nartograstim (Genetical  
Recombination)  
(57) Panipenem (58) Haloperidol Fine Granules  
(59) Calcium Pantothenate  (60) Purified Sodium Hyaluronate  
(61) Bisacodyl Suppositories  (62) L-Histidine  
(63) Hydrocortisone  (64) Hydrocortisone Succinate 
(65) Hydrocortisone Sodium Succinate  (66) Hydrocortisone Acetate  
(67) Hydrocortisone Sodium Phosphate  (68) Hypromellose  
(69) Piroxicam  (70) Filgrastim  
(Genetical Recombination)   
(71) Pravastatin Sodium Fine Granules  (72) Fluoxymesterone  
(73) Fluocinonide  (74) Fluocinolone Acetonide  
(75) Fursultiamine Hydrochloride (76) Prednisolone  
(77) Prednisolone Acetate  (78) Progesterone  
(79) Propylene Glycol  (80) Probucol Fine Granules  
(81) Flomoxef Sodium  (82) Beclometasone Dipropionate  
(83) Betamethasone  (84) Heparin Calcium 
(85) Heparin Sodium  (86) Heparin Sodium Injectio n 
(87) Peplomycin Sulfate  (88) Polysorbate 80  
(89) Maprotiline Hydrochloride  (90) D-Mannitol  
(91) D-Mannitol Injection  (92) Mexiletine Hydrochloride  
(93) Mecobalamin  (94) Metildigoxin  
(95) Methylcellulose  (96) Methylprednisolone Succinate  
(97) Metopr olol Tartrate  (98) Meropenem for Injection  
4 (99) Morphine Hydrochloride Hydrate  (100) Iodamide  
(101) L-Lysine Hydrochloride  (102) Risperidone Fine Granules  
(103) Roxithromycin  (104) Mallotus Bark  
(105) Acacia  (106) Powdered Acacia  
(107) Scutellaria Roo t (108) Powdered Scutellaria Root  
(109) Phellodendron Bark  (110) Coptis Rhizome  
(111) Powdered Coptis Rhizome  (112) Orengedokuto Extract  
(113) Orange Oil  (114) Pogostemon Herb  
(115) Kakkonto Extract  (116) Kamishoyosan Extract  
(117) Glycyrrhiza  (118) Powdered Glycyrrhiza  
(119) Chrysanthemum Flower  (120) Apricot Kernel  
(121) Gentian  (122) Powdered Gentian  
(123) Koi (124) Brown Rice  
(125) Magnolia Bark  (126) Powdered Magnolia Bark  
(127) Sesame  (128) Schisandra Fruit  
(129) Saikokeishito Extract  (130) Saibokuto Extract  
(131) Saireito Extract  (132) Crataegus Fruit  
(133) Gardenia Fruit  (134) Powdered Gardenia Fruit  
(135) Cornus Fruit  (136) Jujube Seed  
(137) Peony Root  (138) Powdered Peony Root  
(139) Shosaikoto Extract  (140) Shoseiryuto Extract  
(141) Exsiccated Gypsum (142) Peucedanum Root  
(143) Toad Cake  (144) Senna Leaf  
(145) Powdered Senna Leaf  (146) Swertia Herb  
(147) Powdered Swertia Herb  (148) Atractylodes Lancea Rhizome  
(149) Powdered Atractylodes Lancea  
Rhizome  (150) Perilla Herb  
(151) Rhubarb  (152) Powdered Rhubarb  
(153) Daiokanzoto Extract  (154) Clove Oil  
(155) Benincasa Seed  (156) Peach Kernel  
(157) Nutmeg  (158) Lonicera Leaf and Stem  
(159) Mentha Herb  (160) Mentha Oil  
(161) Hangekobokuto Extract  (162) Atractylodes Rhizome  
(163) Powdered Atractylodes Rhizome  (164) Areca  
(165) Processed Aconite Root  (166) Powdered Processed Aconite 
Root 
5 (167) Moutan Bark  (168) Powdered Moutan Bark  
(169) Hochuekkito Extract  (170) Ephedra Herb  
(171) Wood Creosote  (172) Japanese Gentian  
(173) Royal Jelly  
 
Annex  4 
 
(1) Terminal Sterilization and  
Sterilization Indicators  (2) Media Fill Test (Process Simulation)  
(3) Quantitative Analytical Technique  
Utilizing Nuclear Magnetic  
Resonance (NMR) Spectroscopy  
and Its Application to Reagents  
in the Japanese Pharmacopoeia  (4) International Harmonization Implemented in the Japanese  
Pharmacopoeia Sixteenth Edition  
  
6