Japanese Pharmacopoeial Forum

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1 Japanese Pharmacopoeial Forum Vol. 15 No. 4 November, 2006 Contents Drafts for Revision L L- 319 L L- 328 L L- 347

2 ii % D

3 iii Drafts for the First Supplement to JP 15. General Notice 413. General Rules for Preparations Extracts Fluidextracts Ophthalmic Ointments Ophthalmic Solutions Tinctures 414. General Tests, Processes and Apparatus Foreign Insoluble Matter Test for Ophthalmic Solutions 415 (2) Revision 1.09 Qualitative Tests Test for Metal Particles in Ophthalmic Ointments Insoluble Particulate Matter Test for Ophthalmic Solutions Reference Standards 415. Official Monographs Amikacin Sulfate Injection 416 Amosulalol Hydrochloride Tablets 416

4 iv Ampicillin Sodium for Injection 418 Benzylpenicillin Potassium for Injection 419 Biotin 420 Bisoprolol Fumarate 421 Bisoprolol Fumarate Tablets 422 Bucillamine Tablets 423 Buformine Hydrochloride Enteric-coated 425 Buprenorphine Hydrochloride 427 Cefadroxil Capsules 428 Cefadroxil for Syrup 429 Cetirizine Hydrochloride 429 Cetirizine Hydrochloride Tablets 430 Cibenzoline Succinate Tablets 431 Cilazapril Hydrate 433 Cilazapril Tablets 434 Clorazepate Dipotassium 436 Clorazepate Dipotassium Capsules 437 L-Cysteine 438 L-Cysteine Hydrochloride Hydrate 439 Domperidone 440 Enalapril Maleate Tablets 441 Etizolam Tablets 443 L-Glutamine 445 Indapamide 446 Isoxsupurine Hydrochloride 447 Isoxsuprine Hydrochloride Tablets 448 Minocycline Hydrochloride for Injection 450 Mizoribine Tablets 451 Nabumetone Tablets 452 Nafamostat Mesilate 453 Omeprazole 455 Peplomycin Sulfate for Injection 456 Piperacillin Hydrate 457 L-Serine 459 Sodium Starch Glycolate 460 L-Tyrosine 462 (2) Revision Creosote 463 Anhydrous Dibasic Calcium Phosphate 463 Dibasic Calcium Phosphate Hydrate 464 Hypromelose Phthalate 465 Anhydrous Lactose 466 Medazepam 467 Parnaparin Sodium 467 Protamine Sulfate 467 Salicylic Acid 468 Talc 469 Teceleukin for Injection (Genetical Recombination) 472 Trimetazidine Hydrochloride 472 Vincristine Sulfate 473. Official Monographs Crude drug (1) Revision Alpinia Officinarum Rhizome 475 Anemarrhena Rhizome 475 Angelica Dahurica Root 475 Apricot Kernel 476 Asparagus Tuber 476 Belladonna Extract 476 Cimicifuga Rhizome 476 Cnidium Rhizome 476 Powdered Cnidium Rhizome 477 Condurango Fluidextract 477 Corydalis Tuber 477 Cyperus Rhizome 477 Powdered Cyperus Rhizome 477 Dioscorea Rhizome 477 Powdered Dioscorea Rhizome 477 Fritillaria Bulb 477 Gastrodia Tuber 478 Glehnia Root 478 Glycyrrhiza Extract 478 Crude Glycyrrhiza Extract 478 Imperata Rhizome 478 Japanese Gentian 478 Powdered Japanese Gentian 479 Lindera Root 479 Lycium Bark 479 Magnolia Bark 479 Powdered Magnolia Bark 480 Mulberry Bark 480 Notopterygium Rhizome 480 Nux Vomica Extract 480 Panax Japonicus Rhizome 481 Powdered Panax Japonicus Rhizome 481 Peach Kernel 481 Powdered Peach Kernel 481 Perilla Herb 482 Platycodon Fluidextract 482 Polygala Root 482 Powdered Polygala Root 482 Polygonum Root 482 Polyporus Sclerotium 483 Powdered Polyporus Sclerotium 483 Processed Aconite Root 483 Powdered Processed Aconite Root 484 Rehmannia Root 485 Ryokeijutsukanto Extract 485 Saposhnikovia Root 487 Scopolia Extract 487 Smilax Rhizome 487 Powdered Smilax Rhizome 487 Sophora Root 487 Powdered Sophora Root 487 Termeric 488

5 v Uva Ursi Fluidextract 488 Zedoary 488 Additional Revision of the Revision Drafts for the First Supplement to JP 15. Official Monographs Amlodipine Besilate 488 Doxorubicin Hydrochloride for Injection 489 Enalapril Maleate 489 Labetalol Hydrochloride 490 Labetalol Hydrochloride Tablets 490 Manidipine Hydrochloride 490 Manidipine Hydrochloride Tablets 490 Mitomycin C for Injection 491 Mizoribine 491 Zidovudine Information International Harmonization Stage 4 (Official Inquiry Stage Draft) (1) (Rev.1) (Stage 4 ) (JP ) 570 Bacterial Endotoxins Test (Rev.1) Stage 4 Draft (by JP) 570 (2) ( Stage 4 ) (EP ) 581 Crospovidone Revised Stage 4 Draft (by EP) 581 Cumulative Contents Vol Vol.15 Cumulative Contents Contents Pages of Pharmacopeial Forum and Pharmeuropa 591 Japanese Pharmacopoeia Reference Standards and Official Non-pharmacopoeial Reference Standards available from the Society of Japanese Pharmacopoeia Ordering Information

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