JP Drafts (September 2, 2019)

JP drafts for public comments, September 2 - 30, 2019

New General Test

• 2.05 Size Exclusion Chromatography (001-1909-1eng.pdf)　

JP drafts for public comments, September 2 - November 30, 2019

Revised General Test

• 2.66 Elemental Impurities (002-1909-1eng.pdf)　

　　　Briefing on Proposed Revision

New monographs

• Bicalutamide (003-1909-1eng.pdf)
• Celecoxib (004-1909-1eng.pdf)
• Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution (005-1909-1eng.pdf)
• Ethyl Loflazepate (006-1909-1eng.pdf)
• Ethyl Loflazepate Tablets (007-1909-1eng.pdf)
• Fenofibrate (008-1909-1eng.pdf)
• Fenofibrate Tablets (009-1909-1eng.pdf)
• Gefitinib (010-1909-1eng.pdf)
• Glucagon (Genetical Recombination) (011-1909-1eng.pdf)
• Heparin Sodium Lock Solution (012-1909-1eng.pdf)
• Heparin Sodium Solution for Dialysis (013-1909-1eng.pdf)
• Irinotecan Hydrochloride Injection (014-1909-1eng.pdf)
• Methotrexate for Injection (015-1909-1eng.pdf)
• Rilmazafone Hydrochloride Hydrate (016-1909-1eng.pdf)
• Rilmazafone Hydrochloride Tablets (017-1909-1eng.pdf)
• Rosuvastatin Calcium (018-1909-1eng.pdf)
• Rosuvastatin Calcium Tablets (019-1909-1eng.pdf)
• Zopiclone (020-1909-1eng.pdf)
• Zopiclone Tablets (021-1909-1eng.pdf)

Ultraviolet-visible reference spectra

• Bicalutamide (022-1909-1eng.pdf)
• Celecoxib (023-1909-1eng.pdf)
• Ethyl Loflazepate (024-1909-1eng.pdf)
• Fenofibrate (025-1909-1eng.pdf)
• Gefitinib (026-1909-1eng.pdf)
• Rilmazafone Hydrochloride Hydrate (027-1909-1eng.pdf)
• Rosuvastatin Calcium (028-1909-1eng.pdf)
• Zopiclone (029-1909-1eng.pdf)

Infrared reference spectra

• Bicalutamide (030-1909-1eng.pdf)
• Celecoxib (031-1909-1eng.pdf)
• Ethyl Loflazepate (032-1909-1eng.pdf)
• Fenofibrate (033-1909-1eng.pdf)
• Gefitinib (034-1909-1eng.pdf)
• Rilmazafone Hydrochloride Hydrate (035-1909-1eng.pdf)
• Rosuvastatin Calcium (036-1909-1eng.pdf)
• Zopiclone (037-1909-1eng.pdf)

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1. Download the form for comments in  Word format
2. Fill in the form
3. Prepare and attach the supportive data that scientifically validate the comment when appropriate
4. Send it to the email address: JPdraft1909-1eng●pmda.go.jp

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Related Information

• Columns (Chemical drug) 

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