The Japanese Pharmacopoeia Fifteenth edition shall be partially amended as follows:




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Description of content:

The Japanese Pharmacopoeia Fifteenth edition shall be partially amended as follows:

1.To amend 1 article under the section of General Notice(List 1)
2.To amend 1 article under the section of General Rules for Crude Drugs(List 2)
3.To amend 5 articles under the section of General Rules for Preparations(List 3)
4.To establish 1 test method under the section of General Tests, Process and Apparatus(List 4)
5.To amend 9 test methods under the section of General Tests, Process and Apparatus(List 5)
6.To delete 6 monographs under the section of Monographs(List 6)
7.To establish 90 monographs under the section of Monographs(List 7)
8.To amend 171 monographs under the section of Monographs(List 8)

List 1  9


List 2  1
List 3

 (1)Extracts (2)Ophthalmic Ointments

 (3)Tinctures (4)Ophthalmic Solutions

 (5)Fluidextracts


List 4

 (1)Foreign Insoluble Matter Test for Ophthalmic Solutions


List 5

 (1)Qualitative Tests (2)Liquid Chromatography

 (3)Gas Chromatography (4)Water Determination

 (5)Optical Rotation Determination (6)Microbial Limit Test

 (7)Test for Metal Particles in Ophthalmic Ointments

 (8)Insoluble Particulate Matter Test for Injections

 (9)Dissolution Test
List 6

 (1)Sulfinpyrazone (2)Sulfinpyrazone Tablets

 (3)Tubocurarine Chloride Hydrochloride Hydrate

 (4)Tubocurarine Chloride Hydrochloride Injection

 (5)Fosfestrol (6)Fosfestrol Tablets
List 7

 (1)Aztreonam for Injection (2)Acemetacin

 (3)Azelastine Hydrochloride (4)Amikacin Sulfate Injection

 (5)Amlodipine Besilate (6)Amosulalol Hydrochloride

 (7)Amosulalol Hydrochloride Tablets (8)Alprostadil Injection

 (9)Alminoprofen (10)Alminoprofen Tablets

 (11)Ampicillin Sodium for Injection (12)Amlexanox

 (13)Amlexanox Tablets (14)Isoxsuprine Hydrochloride

 (15)Isoxsuprine Hydrochloride Tablets (16)Itraconazole

 (17)Ibudilast (18)Ubenimex

 (19)Etizolam Fine Granules (20)Etizolam Tablets

 (21)Enalapril Maleate (22)Enalapril maleate Tablets

 (23)Emorfazone

 (24)Erythromycin Enteric-Coated Tablets (25)Ozagrel Sodium

 (26)Ozagrel Sodium for Injection (27)Omeprazole

 (28)Griseofulvin Tablets (29)Clindamycin Phosphate Injection

 (30)L-Glutamine (31)Clobetasol Propionate

 (32)Clorazepate Dipotassium (33)Clorazepate Dipotassium Capsules

 (34)Chlorphenesin Carbamate Tablets (35)L-Cysteine

 (36)L-Cysteine Hydrochloride Hydrate (37)Zidovudine

 (38)Cibenzoline Succinate (39)Cibenzoline Succinate Tablets

 (40)Josamycin Tablets (41)Cilazapril Hydrate

 (42)Cilazapril Tablets (43)Cetirizine Hydrochloride

 (44)Cetirizine Hydrochloride Tablets (45)Cefazolin Sodium for Injection

 (46)Cefadroxil Capsules (47)Cefadroxil for Syrup

 (48)Ceftazidime for Injection (49)Cefmetazole Sodium for Injection

 (50)L-Serine (51)L-Tyrosine

 (52)Sodium Starch Glycolate

 (53)Doxorubicin Hydrochloride for Injection

 (54)Tobramycin Injection (55)Domperidone

 (56)Nafamostat Mesilate (57)Nabumetone

 (58)Nabumetone Tablets (59)Nizatidine

 (60)Nizatidine Capsules (61)Biotin

 (62)Bisoprolol Fumarate (63)Bisoprolol Fumarate Tablets

 (64)Piperacillin Hydrate (65)Felbinac

 (66)Bucillamine Tablets (67)Buprenorphine Hydrochloride

 (68)Buformine Hydrochloride (69)Buformine Hydrochloride Tablets

 (70)Buformine Hydrochloride Enteric-coated Tablets

 (71)Peplomycin Sulfate for Injection

 (72)Benzylpenicillin Potassium for Injection

 (73)Mitomycin C for Injection (74)Manidipine Hydrochloride

 (75)Manidipine Hydrochloride Tablets (76)Mizoribine

 (77)Mizoribine Tablets

 (78)Minocycline Hydrochloride for Injection

 (79)Labetalol Hydrochloride (80)Labetalol Hydrochloride Tablets

 (81)Rokitamycin Tablets (82)Powdered Turmeric

 (83)Powdered Corydalis Tuber (84)Keishibukuryogan Extract

 (85)Crataegus Fruit (86)Peucedanum Root

 (87)Aralia Rhizome (88)Hangekobokuto Extract

 (89)Lilium Bulb (90)Leonurus Herb


List 8

 (1)Ajmaline Tablets (2)Ascorbic Acid Injection

 (3)Acetylcholine Chloride for Injection (4)Amitriptyline Hydrochloride Tablets

 (5)Aminophyline Injection (6)L-Arginine Hydrochloride Injection

 (7)Idoxuridine Ophthalmic Solution (8)Imipramine Hydrochloride Tablets

 (9)Indometacin Capsules (10)Edrophonium Chloride Injection

 (11)Ephedrine Hydrochloride Tablets (12)Ephedrine Hydrochloride Injection

 (13)Calcium Chloride Hydrate (14)10% Sodium Chloride Injection

 (15)Fructose Injection (16)Gabexate Mesilate

 (17)Camostat Mesilate (18)Xylitol Injection

 (19)Sodium Citrate Injection for Transfusion

 (20)Creosote (21)Chlordiazepoxide Tablets

 (22)Chlorphenesin Carbamate (23)Chlorpropamide Tablets

 (24)Chlorpromazine Hydrochloride Tablets

 (25)Chlorpromazine Hydrochloride Injection

 (26)Salicylic Acid (27)Cyanocobalamin

 (28)Cyanocobalamin Injection (29)Cilostazol Tablets

 (30)Water for Injection (31)Suxamethonium Chloride Injection

 (32)Suxamethonium Chloride for Injection (33)Sultamicillin Tosilate Hydrate

 (34)Sulbactam Sodium (35)Sulpyrine Injection

 (36)Isotonic Sodium Chloride Solution (37)Cefatrizine Propylene Glycolate

 (38)Cefalotin Sodium (39)Talc

 (40)Sodium Bicarbonate Injection

 (41)Thiamine Chloride Hydrochloride Injection

 (42)Thiopental Sodium for Injection (43)Sodium Thiosulfate Injection

 (44)Tipepidine Hibenzate Tablets (45)Dextran 40

 (46)Deslanoside Injection

 (47)Teceleukin for Injection (Genetical Recombination)

 (48)Dehydrocholic Acid Injection (49)Deferoxamine Mesilate

 (50)Dopamine Hydrochloride Injection (51)Trimetazidine Hydrochloride

 (52)Nicardipine Hydrochloride Injection (53)Nicotinic Acid Injection

 (54)Nicorandil (55)Anhydrous Lactose

 (56)Neostigmine Methylsulfate Injection (57)Noradrenaline Injection

 (58)Baclofen Tablets (59)Papaverine Hydrochloride Injection

 (60)Parnaparin Sodium (61)Bisacodyl Suppositories

 (62)Hydralazine Hydrochloride Tablets (63)Hypromellose Phthalate

 (64)Pyridoxine Hydrochloride Injection (65)Vincristine Sulfate

 (66)Famotidine for Injection (67)Faropenem Sodium Hydrate

 (68)Faropenem Sodium Tablets (69)Faropenem Sodium for Syrup

 (70)Glucose Injection

 (71)Prednisolone Sodium Succinate for Injection

 (72)Protamine Sulfate (73)Protamine Sulfate Injection

 (74)Betahistine Mesilate (75)Pethidine Hydrochloride Injection

 (76)Calcium Folinate (77)D-Mannitol Injection

 (78)Medazepam (79)Methyldopa Tablets

 (80)Mefruside Tablets (81)Morphine Hydrochloride Tablets

 (82)Folic Acid Tablets (83)Folic Acid Injection

 (84)Riboflavin Sodium Phosphate Injection

 (85)Magnesium Sulfate Injection (86)Ringer’s Solution

 (87)Anhydrous Dibasic Calcium Phosphate

 (88)Dibasic Calcium Phosphate Hydrate (89)Reserpine Injection

 (90)Levallorphan Tartrate Injection (91)Roxithromycin

 (92)Clematis Root (93)Termeric

 (94)Lindera Root (95)Uva Ursi Fluidextract

 (96)Corydalis Tuber (97)Scutellaria Root

 (98)Powdered Scutellaria Root (99)Coptis Rhizome

 (100)Powdered Coptis Rhizome (101)Polygala Root

 (102)Powdered Polygala Root (103)Polygonum Root

 (104)Zedoary (105)Kakkonto Extract

 (106)Japanese Valerian (107)Powdered Japanese Valerian

 (108)Kamishoyosan Extract (109)Processed Ginger

 (110)Glycyrrhiza Extract (111)Crude Glycyrrhiza Extract

 (112)Platycodon Fluidextract (113)Notopterygium

 (114)Apricot Kernel (115)Sophora Root

 (116)Powdered Sophora Root (117)Gentian

 (118)Powdered Gentian (119)Cyperus Rhizome

 (120)Powdered Cyperus Rhizome (121)Magnolia Bark

 (122)Powdered Magnolia Bark (123)Calumba

 (124)Powdered Calumba (125)Condurango Fluidextract

 (126)Asiasarum Root (127)Smilax Rhizome

 (128)Powdered Smilax Rhizome (129)Dioscorea Rhizome

 (130)Powdered Dioscorea Rhizome (131)Rehmannia Root

 (132)Lycium Bark (133)Lithospermum Root

 (134)Cimicifuga Rhizome (135)Senega

 (136)Powdered Senega (137)Cnidium Rhizome

 (138)Powdered Cnidium Rhizome (139)Nuphar Rhizome

 (140)Mulberry Bark (141)Perilla Herb

 (142)Panax Japonicus Rhizome

 (143)Powdered Panax Japonicus Rhizome

 (144)Anemarrhena Rhizome (145)Polyporus Sclerotium

 (146)Powdered Polyporus Sclerotium (147)Gastrodia Tuber

 (148)Asparagus Tuber (149)Peach Kernel

 (150)Powdered Peach Kernel (151)Ipecac

 (152)Powdered Ipecac (153)Fritillaria Bulb

 (154)Glehnia Root (155)Angelica Dahurica Root

 (156)Atractylodes Rhizome (157)Powdered Atractylodes Rhizome

 (158)Processed Aconite Root (159)Powdered Processed Aconite Root

 (160)Belladonna Extract (161)Imperata Rhizome

 (162)Saposhnikovia Root (163)Hochuekkito Extract

 (164)Nux Vomica Extract (165)Saussurea Root

 (166)Japanese Gentian (167)Powdered Japanese Gentian

 (168)Alpinia Officinarum Rhizome (169)Ryokeijutsukanto Extract



 (170)Scopolia Rhizome (171)Scopolia Extract


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