Japanese Pharmacopoeial Forum
Vol. 23

No. 3

September 2014

Contents

Revision Drafts
Revision Drafts on Dissolution for JP 17
１. Official Monographs(1) Addition
Miglitol Tablets ·········································· 525
Montelkast Sodium Tablets ···························· 526
Pioglitazone Hydrochloride and Glimepiride Tablets··························································· 526
Drafts for JP 17
１. General Rules for Preparations···························· 528
２. General Tests, Processes and Apparatus(1) Revision
6.06 Foreign Insoluble Matter Test for Injections··························································· 528
9.01 Reference Standards ···························· 528
３. Official Monographs(1) Addition
Ampicillin Sodium-Sulbactam Sodium for Injection··························································· 528
Cefalexin Combination Granules ····················· 530
Felbinac Cataplasm ····································· 532
Levofloxacin Injection ·································· 533
Mitiglinide Calcium Hydrate ·························· 534
Mitiglinide Calcium Tablets ··························· 536
Montelukast Sodium ···································· 538
Ozagrel Sodium Injection ······························ 541
Ribavirin ·················································· 542
Ribavirin Capsules ······································ 544
Silodosin ·················································· 545(2) Revision
Benserazide Hydrochloride ···························· 548
Cefroxadine Hydrate ···································· 548
Gabexate Mesilate ······································· 549
Gelatin ····················································· 549
Ozagrel Sodium for Injection ·························· 550
Progesterone Injection ·································· 550
Spectinomycin Hydrochloride Hydrate ·············· 550
Thiamine Chloride Hydrochloride ···················· 551
Tulobuterol Hydrochloride ····························· 552(3) On Unified Revision of the Uniformity of dosage units

in Drug Monographs ······································ 552
Alacepril Tablets········································· 553
Aldioxa Tablets ·········································· 553
Alendronate Sodium Tablets ··························· 553
Allopurinol Tablets ······································ 553
Amiodarone Hydrochloride Tablets ·················· 553
Amlexanox Tablets ······································ 553
Azathioprine Tablets ···································· 553
Bucillamine Tablets ····································· 553
Buformin Hydrochloride Tablets······················ 553
Cefalexin Capsules ······································ 553
Cefcapene Pivoxil Hydrochloride Tablets ········· 553
Cefditoren Pivoxil Tablets ····························· 553
Cefixime Capsules······································· 553
Cefpodoxime Proxetil Tablets ························· 553
Cefteram Pivoxil Tablets ······························· 553
Chlorphenesin Carbamate Tablets ···················· 553
Cibenzoline Succinate Tablets························· 553
Cilostazol Tablets········································ 553
Clarithromycin Tablets ································· 553
Clopidogrel Sulfate Tablets ···························· 553
Diethylcarbamazine Citrate Tablets ·················· 553
Droxidopa Capsules ····································· 553
Epalrestat Tablets ········································ 553
Faropenem Sodium Tablets ···························· 553
Fexofenadine Hydrochloride Tablets ················· 553
Flecainide Acetate Tablets ····························· 553
Fluconazole Capsules ··································· 553
Fluvoxamine Maleate Tablets ························· 553
Furosemide Tablets ····································· 553
Labetalol Hydrochloride Tablets ······················ 553
Levofloxacin Tablets ···································· 553
Losartan Potassium Tablets ···························· 553
Losartan Potassium and Hydrochlorothiazide Tablets··························································· 553
Loxoprofen Sodium Tablets ··························· 553
Metoprolol Tartrate Tablets ···························· 553
Minocycline Hydrochloride Tablets ·················· 553
Mizoribine Tablets ······································ 553
Naftopidil Orally Disintegrating Tablets ·········· 553

iiNateglinide Tablets ······································ 553
Nizatidine Capsules ····································· 553
Phenytoin Tablets ······································· 553
Pilsicainide Hydrochloride Capsules ················· 553
Pioglitazone Hydrochloride Tablets ·················· 553
Propafenone Hydrochloride Tablets ·················· 553
Propylthiouracil Tablets ································ 553
Quetiapine Fumarate Tablets ·························· 553
Rebamipide Tablets ····································· 553
Roxatidine Acetate Hydrochloride Extended-release
Capsules ················································ 553
Sarpogrelate Hydrochloride Tablets ·················· 553
Sodium Risedronate Tablets ··························· 553
Sodium Valproate Tablets ······························ 553
Spironolactone Tablets ································· 553
Sulpiride Capsules ······································· 553
Sulpiride Tablets ········································· 553
Tiapride Hydrochloride Tablets ······················· 553
Tosufloxacin Tosilate Tablets ························· 553
Tranilast Capsules ······································· 553
Troxipide Tablets ········································ 553
Ursodeoxycholic Acid Tablets ························ 553
Valsartan Tablets ········································ 553
Zaltoprofen Tablets ····································· 553(4) Deletion
Serum Gonadotrophin ·································· 554
Serum Gonadotrophin for Injection··················· 554
４. Official Monographs－Crude Drugs(1) Revision
Artemisia Capillaris Flower···························· 554
Bakumondoto Extract ··································· 554
Belladonna Root ········································· 554
Burdock Fruit ············································ 554
Chotosan Extract ········································ 555
Cinnamon Bark ·········································· 555
Powdered Cinnamon Bark ····························· 555
Coptis Rhizome ·········································· 555
Powdered Coptis Rhizome ····························· 556
Daisaikoto Extract ······································· 556
Fennel ····················································· 557
Powdered Fennel ········································ 557
Fennel Oil ················································· 557
Fritillaria Bulb ··········································· 557
Gastrodia Tuber ·········································· 557
Glycyrrhiza ··············································· 558
Powdered Glycyrrhiza ·································· 558
Hangeshashinto Extract································· 558
Hochuekkito Extract ···································· 558
Juzentaihoto Extract ····································· 559
Kakkonto Extract ········································ 559
Kakkontokasenkyushin'i Extract ······················ 559
Lilium Bulb··············································· 560

Lithospermum Root ····································· 560
Loquat Leaf ··············································· 560
Lycium Fruit ············································· 560
Magnolia Flower········································· 560
Notopterygium ··········································· 561
Peach Kernel ············································· 561
Powdered Peach Kernel ································ 561
Peony Root ··············································· 561
Powdered Peony Root ·································· 562
Phellodendron Bark ····································· 562
Powdered Phellodendron Bark ························ 562
Compound Phellodendron Powder for Cata-plasm··························································· 562
Phellodendron, Albumin Tannate and Bis-muth
Subnitrate Powder ······································· 563
Pueraria Root ············································· 563
Rikkunshito Extract ····································· 563
Saibokuto Extract ········································ 563
Saikokeishito Extract ··································· 564
Saireito Extract··········································· 564
Scopolia Extract and Ethyl Aminobenzoate Powder··························································· 564
Scopolia Rhizome ······································· 565
Scutellaria Root ·········································· 565
Powdered Scutellaria Root ····························· 565
Senna Leaf ················································ 565
Powdered Senna Leaf ··································· 566
Shakuyakukanzoto Extract ····························· 566
Shimbuto Extract ········································ 566
Shosaikoto Extract······································· 567
Shoseiryuto Extract ····································· 567
Swertia Herb ············································· 567
Powdered Swertia Herb································· 567
Swertia and Sodium Bicarbonate Powder ··········· 567
Tokishakuyakusan Extract ····························· 568
Tribulus Fruit ············································· 568
５. Infrared Reference Spectra
Benserazide Hydrochloride ···························· 568
Cefroxadine Hydrate ···································· 569
Mitiglinide Calcium Hydrate ·························· 569
Montelukast Sodium ···································· 569
Ribavirin ·················································· 570
Silodosin ·················································· 570
Thiamine Chloride Hydrochloride ···················· 570
６. Ultraviolet-visible Reference Spectra
Mitiglinide Calcium Hydrate ·························· 571
Montelukast Sodium ···································· 571
Ribavirin ·················································· 572
Silodosin ·················································· 572
７. General Information(1) Addition
Surface Plasmon Resonance ··························· 573iii

Additional Revision of the Revision Drafts for JP 17
１. Official Monographs(1) Addition
Diltiazem Hydrochloride Extended-release Capsules·························································· 577
Ethyl Icosapentate Capsules ··························· 577
Interferon Alfa (NAMALWA) ························ 578
２. Official Monographs－Crude Drugs
Additional Expression for Water Determination ofReference Standard used in Assay of Crude Drugs·························································· 579

Pharmacopoeial Harmonization
１.Harmonized Document(1) General Tests
1)Addition①Thermal Analysis(Sign-off document) ·············· 423
2)Revision, Correction①Polyacrylamide Gel Electrophoresis(Rev. 1) ······· 430(2) Monographs
1)Addition①Glucose Anhydrous/Monohydrate ··················· 443
2) Revision, Correction①Ethanol(Rev. 2, corr. 2) ································ 454②Ethanol Anhydrous(Rev. 2, corr. 2) ·················· 455③Gelatin, Gelling grade(Corr. 2)(差し替え) ········· 456④Gelatin, Non-gelling grade(Corr. 2)(差し替え) ··· 462⑤Mannitol, (Corr. 1)······································ 469⑥Hypromellose (Rev.1, Corr.1) ························ 470⑦Methylcellulose (Rev. 2, Corr. 1) ···················· 477

Useful Information
PMRJ Reference Standards Ordering Information for Foreign
Users ··························································· 580

Publishing Schedule (Vol.23, No.4): December 2014