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(JP) Shall Be Established As Follows: 1. to Establ

(JP) Shall Be Established As Follows: 1. to Establ

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The Seventeenth edition of the Japanese Pharmacopoeia (JP) shall be established as follows:

1. To establish 4 articles under the section of General Notices (List 1)

2. To amend 6 articles under the section of General Notices (List 2)

3. To amend 3 articles under the section of General Rules of Crude Drugs (List 3)

4. To establish 1 article under the section of General Rules of Preparations (List 4)

5. To amend 2 articles under the section of General Rules of Preparations (List 5)

6. To establish 5 test methods under the section of General Tests, Process and Apparatus (List 6)

7. To amend 18 test methods under the section of General Tests, Process and Apparatus (List 7)

8. To delete 1 test method under the section of General Tests, Process and Apparatus (List 8)

9. To establish 76 monographs under the section of Official Monographs (List 9)

10. To amend 472 monographs under the section of Official Monographs (List 10)

11. To delete 10 monographs under the section of Official Monographs (List 11)

12. To establish 21 spectra under the section of Infrared Reference Spectra (List 12)

13. To amend 2 spectra under the section of Infrared Reference Spectra (List 13)

14. To delete 3 spectra under the section of Infrared Reference Spectra (List 14)

15. To establish 14 spectra under the section of Ultraviolet-visible Reference Spectra (List 15)

16. To delete 2 spectra under the section of Ultraviolet-visible Reference Spectra (List 16)

17. To establish 11 paragraphs under the section of General Information (List 17)

18. To amend 9 paragraphs under the section of General Information (List 18)

19. To delete 2 paragraphs under the section of General Information (List 19)

 Established articles are listed with the planning numbers in JP seventeenth edition (JP17).  Amended or deleted articles are listed with the numbers in JP sixteenth edition (JP16).  The names of articles in English may change through the process of official English translation of JP17.

List 1 12 Article of important matters in manufacturing process 34 Article of residual solvents 35 Article of toxic substances mixed intentionally 40 Article of definitions of asepsis, sterilization and aseptic manipulation

List 2 1, 2, 5, 11, 33, 44 of JP16

List 3 1, 4, 5 of JP16

List 4 [2] General notices for Preparation packaging

List 5 Following articles of General Rules of Preparations of JP16 [1] General Notices for Preparations [2] Monographs for Preparations 3.1. Injections 4.1. Dialysis Agents 6.1. Ophthalmic Preparations 7.1. Ear Preparations 11.7. Patches 11.7.1.Tapes/Plasters

List 6 (1) 2.64 Glycosylation analysis of (2) 2.65 Degree of coloration of liquids Glycoprotein test (3) 3.05 Determination of (4) 6.12 Methods of adhesion testing sorption-desorption isotherms and of water activity (5) 6.13 Methods of drug release testing for preparations for cutaneous application

List 7 Following test methods of General Tests, Process and Apparatus of JP16 (1) 2.21 Nuclear Magnetic (2) 2.46 Residual Solvents Test Resonance Spectroscopy (3) 2.49 Optical Rotation (4) 2.52 Thermal Analysis Determination (5) 2.60 Melting Point Determination (6) 3.01 Determination of Bulk and Tapped Densities (7) 5.01 Crude Drugs Test (8) 5.02 Microbial Limit Test for Crude Drugs (9) 6.02 Uniformity of Dosage Units (10) 6.05 Test for Extractable Volume of Parenteral Preparations (11) 6.06 Foreign Insoluble Matter (12) 9.01 Reference Standards Test for Injections (13) 9.21 Standard Solutions for (14) 9.22 Standard Solutions Volumetric Analysis (15) 9.23 Matching Fluids for Color (16) 9.41 Reagents, Test Solutions (17) 9.42 Solid Supports/Column (18) 9.44 Standard Particles, etc. Packings for Chromatography

List 8 Following test method of General Tests, Process and Apparatus of JP16 (1) 8.01 Sterilization and Aseptic Manipulation

List 9 (1) Ascorbic Acid and Calcium (2) Ampicillin Sodium-Sulbactam Sodium Pantothenate Tablets for Injection (3) (4) Ampiroxicam Capsules (5) Ethyl Icosapentate Capsules (6) Isomalt Hydrate (7) Irbesartan (8) Interferon Alfa (NAMALWA) (9) Interferon Alfa (NAMALWA) Injection (10) Eplerenone (11) Eplerenone Tablets (12) Ozagrel Sodium Injection (13) Hypromellose Capsules (14) Pullulan Capsules (15) L-Carbocisteine Tablets (16) Candesartan Cilexetil and Hydrochlorothiazide Tablets (17) Citicoline (18) Ciprofloxacin (19) Ciprofloxacin Hydrochloride Hydrate (20) Diflorasone Diacetate (21) Diltiazem Hydrochloride (22) Cilnidipine Extended-release Capsules (23) Cilnidipine Tablets (24) Silodosin (25) Silodosin Tablets (26) Spectinomycin Hydrochloride for Injection (27) Sultamicillin Tosilate Tablets (28) Cefalexin Combination Granules (29) Cefoperazone Sodium-Sulbactam (30) Cefpodoxime Proxetil for Syrup Sodium for Injection (31) Tacrolimus Capsules (32) Ticlopidine Hydrochloride Tablets (33) Tulobuterol (34) Tulobuterol Transdermal Tapes (35) Teprenone Capsules (36) Terbinafine Hydrochloride Tablets (37) Doxycycline Hydrochloride Tablets (38) Trientine Hydrochloride (39) Trientine Hydrochloride Capsules (40) Sodium L-Lactate Ringer´s Solution (41) Panipenem and Betamipron for (42) Valaciclovir Hydrochloride Injection (43) Valaciclovir Hydrochloride Tablets (44) Haloperidol Injection (45) Purified Sodium Hyaluronate Injection (46) Purified Sodium Hyaluronate Ophthalmic Solution (47) Pioglitazone Hydrochloride and (48) Tape Tablets (49) Felbinac Cataplasm (50) Fluconazole Injection (51) Fosfomycin Calcium for Syrup (52) Voriconazole (53) Voriconazole Tablets (54) Miglitol (55) Mitiglinide Calcium Hydrate (56) Mitiglinide Calcium Tablets (57) Medroxyprogesterone (58) Acetate Montelukast Sodium (59) Montelukast Sodium Tablets (60) Montelukast Sodium Chewable Tablets (61) Lansoprazole (62) Lansoprazole Delayed-Release Orally Disintegration Tablets (63) Lansoprazole Delayed-release (64) Ribavirin Capsules (65) Ribavirin Capsules (66) Levofloxacin Injection (67) Kamikihito Extract (68) Hedysarum Root (69) Salvia Miltiorrhiza Root (70) Tokakujokito Extract (71) Codonopsis Root (72) Boiogito Extract (73) Sodium Sulfate Hydrate (74) Anhydrous Sodium Sulfate (75) Bofutsushosan Extract (76) Yokukansan Extract

List 10 Following monographs of Official Monographs of JP16 (1) Azathioprine Tablets (2) Aciclovir (3) Azithromycin Hydrate (4) Acetylcysteine (5) Azelnidipine (6) Atorvastatin Calcium Hydrate (7) Atropine Sulfate Hydrate (8) Arsenical Paste (9) Aprindine Hydrochloride (10) Amiodarone Hydrochloride (11) Amiodarone Hydrochloride Tablets (12) Aminophylline Hydrate (13) Aminophylline Injection (14) Amphotericin B Tablets (15) Amphotericin B for Injection (16) Amlodipine Besilate (17) Alacepril Tablets (18) Hydrate (19) Aldioxa Tablets (20) Alprostadil Injection (21) Arbekacin Sulfate (22) Alendronate Sodium Hydrate (23) Alendronate Sodium Tablets (24) Allopurinol Tablets (25) Ampicillin Sodium (26) Amlexanox Tablets (27) Iohexol (28) Idarubicin Hydrochloride (29) Isosorbide Mononitrate 70% / Lactose (30) Piconol 30% (31) Ipratropium Bromide Hydrate (32) Ipriflavone (33) Imidapril Hydrochloride (34) Imipenem and Cilastatin Sodium for Injection (35) Irsogladine Maleate (36) Insulin Human (Genetical Recombination) (37) Insulin Human (Genetical (38) Insulin Glargine (Genetical Recombination) Injection Recombination) (39) Insulin Glargine (Genetical (40) Indapamide Recombination) Injection (41) Indenolol Hydrochloride (42) Ursodeoxycholic Acid Tablets (43) Ecabet Sodium Hydrate (44) Ecothiopate Iodide (45) Estradiol Benzoate Injection (Aqueous (46) Estriol Injection (Aqueous Suspension) Suspension) (47) Ethanol (48) Anhydrous Ethanol (49) Ethanol for Disinfection (50) Edaravone (51) Ethambutol Hydrochloride (52) Ethylmorphine Hydrochloride Hydrate (53) Edrophonium Chloride (54) Edrophonium Chloride Injection (55) Enoxacin Hydrate (56) Ebastine (57) Epalrestat (58) Epalrestat Tablets (59) Epoetin Alfa (Genetical (60) Epoetin Beta (Genetical Recombination) Recombination) (61) Emedastine Fumarate (62) Erythromycin Delayed-Release Tablets (63) Sodium Chloride (64) Enviomycin Sulfate (65) Oxycodone Hydrochloride Hydrate (66) Compound Oxycodone Injection (67) Compound Oxycodone and Atropine (68) Ozagrel Sodium for Injection Injection (69) Omeprazole (70) Omeprazole Delayed-Release Tablets (71) Auranofin (72) Olmesartan Medoxomil (73) Olopatadine Hydrochloride (74) Cadralazine (75) Capsules (76) Gabexate Mesilate (77) Calcitonin Salmon (78) Carvedilol (79) Carboplatin (80) Candesartan Cilexetil (81) dl-Camphor (82) Kitasamycin Tartrate (83) Quinapril Hydrochloride (84) Quinidine Sulfate Hydrate (85) Quinine Ethyl Carbonate (86) Quinine Hydrochloride Hydrate (87) Quinine Sulfate Hydrate (88) Sodium Aurothiomalate (89) Guanethidine Sulfate (90) Potassium Guaiacolsulfonate (91) Quetiapine Fumarate (92) Quetiapine Fumarate Tablets (93) Clarithromycin Tablets (94) Gliclazide (95) Glimepiride (96) Clebopride Malate (97) Clocapramine Hydrochloride Hydrate (98) Cloxacillin Sodium Hydrate (99) Clopidogrel Sulfate (100) Clopidogrel Sulfate Tablets (101) Clomifene Citrate (102) Chloramphenicol Sodium Succinate (103) Chloramphenicol Palmitate (104) Chlorphenesin Carbamate Tablets (105) Ketoconazole (106) Gefarnate (107) Gentamicin Sulfate (108) Codeine Phosphate Hydrate (109) Gonadorelin Acetate (110) Colistin Sodium Methanesulfonate (111) Colistin Sulfate (112) Colestimide (113) Saccharin (114) Zaltoprofen Tablets (115) Sarpogrelate Hydrochloride (116) Sarpogrelate Hydrochloride Tablets (117) Arsenic Trioxide (118) Cyanocobalamin (119) Diethylcarbamazine Citrate Tablets (120) L-Cystine (121) Cinoxacin (122) Dihydrocodeine Phosphate (123) Diflucortolone Valerate (124) Cyproheptadine Hydrochloride Hydrate (125) Sivelestat Sodium Hydrate (126) Cibenzoline Succinate Tablets (127) Dilazep Hydrochloride Hydrate (128) Cilostazol Tablets (129) Simvastatin (130) Suxamethonium Chloride Hydrate (131) Scopolamine Hydrobromide Hydrate (132) Stearic Acid (133) Spironolactone Tablets (134) Spectinomycin Hydrochloride Hydrate (135) (136) Sultamicillin Tosilate Hydrate (137) Sulpiride Tablets (138) Sulpiride Capsules (139) Cetirizine Hydrochloride Tablets (140) Cetotiamine Hydrochloride Hydrate (141) Cefaclor Combination Granules (142) Cefazolin Sodium Hydrate (143) Cefalexin Capsules (144) Cefixime Capsules (145) Cefotiam Hexetil Hydrochloride (146) Cefcapene Pivoxil Hydrochloride Hydrate (147) Cefcapene Pivoxil Hydrochloride (148) Cefditoren Pivoxil Tablets (149) Cefditoren Pivoxil Tablets (150) Cefteram Pivoxil Tablets (151) Ceftriaxone Sodium Hydrate (152) Cefpirome Sulfate (153) Cefpodoxime Proxetil Tablets (154) Cefroxadine Hydrate (155) Sevoflurane (156) Gelatin (157) Purified Gelatin (158) Celmoleukin (Genetical Recombination) (159) Zolpidem Tartrate (160) Tacalcitol Hydrate (161) Tacrolimus Hydrate (162) Tazobactam (163) Danazol (164) Tamoxifen Citrate (165) Taltirelin Hydrate (166) Dantrolene Sodium Hydrate (167) Tiapride Hydrochloride (168) Tiapride Hydrochloride Tablets (169) Thiamine Chloride Hydrochloride (170) Thioridazine Hydrochloride (171) Ticlopidine Hydrochloride (172) Tipepidine Hibenzate (173) Timepidium Bromide Hydrate (174) Tulobuterol Hydrochloride (175) Dextromethorphan Hydrobromide (176) Teceleukin (Genetical Recombination) Hydrate (177) Teceleukin for Injection (178) Teprenone (Genetical Recombination) (179) Temocapril Hydrochloride (180) Terbinafine Hydrochloride (181) Telmisartan (182) Wheat Starch (183) Rice Starch (184) Sodium Starch Glycolate (185) Doxazosin Mesilate (186) Doxapram Hydrochloride Hydrate (187) Doxycycline Hydrochloride Hydrate (188) Tosufloxacin Tosilate Hydrate (189) Tosufloxacin Tosilate Tablets (190) Docetaxel Hydrate (191) Docetaxel for Injection (192) Todralazine Hydrochloride Hydrate (193) Donepezil Hydrochloride (194) Tranilast (195) Tranilast Capsules (196) Trimetoquinol Hydrochloride Hydrate (197) Dorzolamide Hydrochloride (198) Droxidopa (199) Droxidopa Capsules (200) Troxipide (201) Troxipide Tablets (202) Droperidol (203) Domperidone (204) Nateglinide (205) Nateglinide Tablets (206) Nafamostat Mesilate (207) Naftopidil (208) Naftopidil Orally Disintegrating Tablets (209) Nartograstim (Genetical (210) Nartograstim for Injection (Genetical Recombination) Recombination) (211) Nizatidine Capsules (212) Nifedipine (213) Nifedipine Delayed-Release Fine (214) Noscapine Hydrochloride Hydrate Granules (215) Nortriptyline Hydrochloride (216) Bacampicillin Hydrochloride (217) Panipenem (218) Bamethan Sulfate (219) Calcium Paraaminosalicylate Hydrate (220) Valsartan (221) Valsartan Tablets (222) Sodium Valproate Tablets (223) Paroxetine Hydrochloride Hydrate (224) Purified Sodium Hyaluronate (225) Pioglitazone Hydrochloride (226) Pioglitazone Hydrochloride Tablets (227) Pitavastatin Calcium Hydrate (228) Hydroxyzine Hydrochloride (229) Hydroxyzine Pamoate (230) Hydroxypropylcellulose (231) Hydroxocobalamin Acetate (232) Hydrocotarnine Hydrochloride Hydrate (233) Hypromellose (234) Piperazine Adipate (235) Piperazine Phosphate Hydrate (236) Bifonazole (237) Pimozide (238) Pyrantel Pamoate (239) Pyridoxine Hydrochloride (240) Pilsicainide Hydrochloride Hydrate (241) Pilsicainide Hydrochloride Capsules (242) Pirenzepine Hydrochloride Hydrate (243) Faropenem Sodium Hydrate (244) Faropenem Sodium Tablets (245) Filgrastim (Genetical Recombination) (246) Filgrastim (Genetical Recombination) Injection (247) Fexofenadine Hydrochloride (248) Fexofenadine Hydrochloride Tablets (249) Phenytoin Tablets (250) Liquefied Phenol (251) Phenol for Disinfection (252) Phenolated Water (253) Phenolated Water for Disinfection (254) Felbinac (255) Fentanyl Citrate (256) (257) Bucumolol Hydrochloride (258) Bucillamine Tablets (259) Butenafine Hydrochloride (260) Wine (261) Fudosteine (262) Bunazosin Hydrochloride (263) Bupivacaine Hydrochloride Hydrate (264) Bupranolol Hydrochloride (265) Buformin Hydrochloride Tablets (266) Buformin Hydrochloride Delayed-Release Tablets (267) Prasterone Sodium Sulfate Hydrate (268) Prazosin Hydrochloride (269) Pravastatin Sodium (270) Pranlukast Hydrate (271) Fluorescein Sodium (272) Fluconazole (273) Fluconazole Capsules (274) Flutamide (275) Flutoprazepam (276) Fludrocortisone Acetate (277) Fluphenazine Enanthate (278) Fluvoxamine Maleate (279) Fluvoxamine Maleate Tablets (280) (281) Flecainide Acetate (282) Flecainide Acetate Tablets (283) Prednisolone Sodium Phosphate (284) Procaterol Hydrochloride Hydrate (285) Prochlorperazine Maleate (286) Progesterone Injection (287) Furosemide Tablets (288) Brotizolam (289) Protirelin Tartrate Hydrate (290) Propafenone Hydrochloride (291) Propafenone Hydrochloride Tablets (292) Propiverine Hydrochloride (293) Propylthiouracil Tablets (294) Probucol (295) L-Proline (296) Betaxolol Hydrochloride (297) Betahistine Mesilate (298) Betamethasone (299) Betamethasone Tablets (300) Heparin Calcium (301) Heparin Sodium (302) Bepotastine Besilate (303) Pemirolast Potassium (304) Sodium (305) Perphenazine Maleate (306) Berberine Chloride Hydrate (307) Benzylpenicillin Potassium (308) Benzylpenicillin Benzathine Hydrate (309) Benserazide Hydrochloride (310) Penbutolol Sulfate (311) Povidone (312) Polysorbate 80 (313) Calcium Folinate (314) Polymixin B Sulfate (315) Mizoribine Tablets (316) Minocycline Hydrochloride Tablets (317) Mecobalamin (318) Methamphetamine Hydrochloride (319) Metildigoxin (320) Methylcellulose (321) Methyldopa Hydrate (322) Methylprednisolone Succinate (323) Metenolone Enanthate Injection (324) Metoprolol Tartrate Tablets (325) Mefloquine Hydrochloride (326) Mosapride Citrate Hydrate (327) Morphine Hydrochloride Hydrate (328) Morphine Sulfate Hydrate (329) Lafutidine (330) Labetalol Hydrochloride Tablets (331) Rabeprazole Sodium (332) Risperidone (333) Sodium Risedronate Hydrate (334) Sodium Risedronate Tablets (335) Lysozyme Hydrochloride (336) Lincomycin Hydrochloride Hydrate (337) Anhydrous Dibasic Calcium (338) Dibasic Sodium Phosphate Hydrate Phosphate (339) Monobasic Calcium Phosphate (340) Lenograstim (Genetical Hydrate Recombination) (341) Rebamipide (342) Rebamipide Tablets (343) Levofloxacin Hydrate (344) Levofloxacin Tablets (345) Roxatidine Acetate Hydrochloride (346) Roxithromycin Extended-release Capsules (347) Sodium Tablets (348) Losartan Potassium (349) Losartan Potassium Tablets (350) Losartan Potassium and Hydrochlorothiazide Tablets (351) Lobenzarit Sodium (352) Sweet Hydrangea Leaf (353) Acacia (354) Powdered Acacia (355) Clematis Root (356) Artemisia Capillaris Flower (357) Fennel (358) Powdered Fennel (359) Fennel Oil (360) Corydalis Tuber (361) Powdered Corydalis Tuber (362) Astragalus Root (363) Scutellaria Root (364) Powdered Scutellaria Root (365) Phellodendron Bark (366) Powdered Phellodendron Bark (367) Compound Phellodendron Powder for (368) Phellodendron, Albumin Tannate and Cataplasm Bismuth Subnitrate Powder (369) Coptis Rhizome (370) Powdered Coptis Rhizome (371) Orengedokuto Extract (372) Otsujito Extract (373) Pueraria Root (374) Kakkonto Extract (375) Kakkontokasenkyushin’i Extract (376) Japanese Valerian (377) Powdered Japanese Valerian (378) Kamishoyosan Extract (379) Processed Ginger (380) Glycyrrhiza (381) Powdered Glycyrrhiza (382) Glycyrrhiza Extract (383) Crude Glycyrrhiza Extract (384) Notopterygium (385) Lycium Fruit (386) Keishibukuryogan Extract (387) Cinnamon Bark (388) Powdered Cinnamon Bark (389) Red Ginseng (390) Goshajinkigan Extract (391) Burdock Fruit (392) Saikokeishito Extract (393) Asiasarum Root (394) Saibokuto Extract (395) Saireito Extract (396) Japanese Zanthoxylum Peel (397) Powdered Japanese Zanthoxylum (398) Dioscorea Rhizome Peel (399) Powdered Dioscorea Rhizome (400) Lithospermum Root (401) Tribulus Fruit (402) Prepared Glycyrrhiza (403) Peony Root (404) Powdered Peony Root (405) Shakuyakukanzoto Extract (406) Plantago Seed (407) Juzentaihoto Extract (408) Amomum Seed (409) Powdered Amomum Seed (410) Shosaikoto Extract (411) Shoseiryuto Extract (412) Cimicifuga Rhizome (413) Magnolia Flower (414) Shimbuto Extract (415) Peucedanum Root (416) Senna Leaf (417) Powdered Senna Leaf (418) Swertia Herb (419) Powdered Swertia Herb (420) Swertia and Sodium Bicarbonate Powder (421) Rhubarb (422) Powdered Rhubarb (423) Daiokanzoto Extract (424) Mukoi-Daikenchuto Extract (425) Daisaikoto Extract (426) Alisma Tuber (427) Anemarrhena Rhizome (428) Chotosan Extract (429) Gastrodia Tuber (430) Asparagus Root (431) Capsicum (432) Powdered Capsicum (433) Japanese Angelica Root (434) Powdered Japanese Angelica Root (435) Tokishakuyakusan Extract (436) Peach Kernel (437) Powdered Peach Kernel (438) Aralia Rhizome (439) Ipecac (440) Powdered Ipecac (441) Ipecac Syrup (442) Ginseng (443) Powdered Ginseng (444) Fritillaria Bulb (445) Ophiopogon Root (446) Bakumondoto Extract (447) Hachimijiogan Extract (448) Mentha Herb (449) Hangekobokuto Extract (450) Hangeshashinto Extract (451) Lilium Bulb (452) Loquat Leaf (453) Processed Aconite Root (454) Powdered Processed Aconite Root (455) Belladonna Root (456) Belladonna Extract (457) Belladonna Total Alkaloids (458) Hochuekkito Extract (459) Nux Vomica (460) Nux Vomica Extract (461) Nux Vomica Extract Powder (462) Nux Vomica Tincture (463) Maoto Extract (464) Saussurea Root (465) Rikkunshito Extract (466) Powdered Japanese Gentian (467) Ryokeijutsukanto Extract (468) Forsythia Fruit (469) Scopolia Rhizome (470) Scopolia Extract (471) Scopolia Extract Powder (472) Scopolia Extract and Ethyl Aminobenzoate Powder

List 11 Following monographs of Official Monographs of JP16 (1) Estradiol Benzoate Injection (2) Griseofulvin (3) Griseofulvin Tablets (4) Chlorpheniramine and Calcium Powder (5) Siccanin (6) Serum Gonadotrophin (7) Serum Gonadotrophin for Injection (8) Vitamin A Oil Capsules (9) Iodaminde (10) Meglumine Sodium Iodamide Injection

List 12 (1) Ampiroxicam (2) Irbesartan (3) Eplerenone (4) Citicoline (5) Ciprofloxacin (6) Ciprofloxacin Hydrochloride Hydrate (7) Diflorasone Diacetate (8) Cilnidipine (9) Silodosin (10) Cefroxadine Hydrate (11) Tulobuterol (12) Trientine Hydrochloride (13) Valaciclovir Hydrochloride (14) Hydroxypropylcellulose (15) Voriconazole (16) Miglitol (17) Mitiglinide Calcium Hydrate (18) Medroxyprogesterone Acetate (19) Montelukast Sodium (20) Lansoprazole (21) Ribavirin

List 13 Following spectra of Infrared Reference Spectra of JP16 (1) Thiamine Chloride Hydrochloride (2) Benserazide Hydrochloride

List 14 Following spectra of Infrared Reference Spectra of JP16 (1) Griseofulvin (2) Siccanin (3) Iodaminde

List 15 (1) Ampiroxicam (2) Irbesartan (3) Eplerenone (4) Citicoline (5) Cilnidipine (6) Silodosin (7) Tulobuterol (8) Valaciclovir Hydrochloride (9) Voriconazole (10) Mitiglinide Calcium Hydrate (11) Medroxyprogesterone Acetate (12) Montelukast Sodium (13) Lansoprazole (14) Ribavirin

List 16 Following spectra of Ultraviolet-visible Reference Spectra of JP16 (1) Griseofulvin (2) Siccanin

List 17 (1) Monosaccharide analysis and (2) Surface plasmon resonance oligosaccharide analysis / oligosaccharide profiling (3) Rapid microbiological methods (4) Analytical methods for aflatoxins in crude drug and its product (5) Thin-layer Chromatography for crude (6) Notification for the quantitative marker drugs and crude drug products constituents of crude drugs and crude drug preparations (7) Standard procedure for mechanical (8) Basic requirements and terms for the calibration of dissolution apparatus packaging of pharmaceutical products (9) Basic concepts for reference (10) Basic concepts for quality assurance standards and reference materials in of drug substances and drug products Japanese pharmacopoeia (11) Basic concepts for quality risk management

List 18 Following paragraphs of General Information of JP16 (1) SDS-Polyacrylamide Gel (2) Mycoplasma Testing for Cell Electrophoresis Substrates used for the Production of Biotechnological / Biological Products (3) Disinfection and Sterilization Methods (4) Microbial Attributes of Non-sterile Pharmaceutical Products (5) Preservatives-Effectiveness Tests (6) Sterility Assurance for Terminally Sterilized Pharmaceutical Products (7) On the Scientific Names of Crude (8) Quantitative Analytical Technique Drugs Listed in the JP Utilizing Nuclear Magnetic Resonance (NMR) Spectroscopy and Its Application to Reagents in the Japanese Pharmacopoeia (9) International Harmonization Implemented in the Japanese Pharmacopoeia Sixteenth Edition

List 19 Following paragraphs of General Information of JP16 (1) Guideline for Residual Solvents and (2) Water-Solid Interactions: Models for the Residual Solvents Test Determination of Sorption-Desorption Isotherms and of Water Activity