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This is a draft proposal of a revised monograph for The International Pharmacopoeia (Working document QAS/16.674, July 2016).
The working document with line numbers and tracked changes is available for comment at www.who.int/medicines/areas/quality safety/quality assurance/ projects. Please address any comments to: World Health Organization, Quality Assurance and Safety: Medicines, Dr Herbert Schmidt, 1211 Geneva 27, Switzerland; fax: +41 22 791 4730; email: [email protected].
[Note from the Secretariat. It is proposed to revise the monograph on Mebendazole of The International Pharmacopoeia./
[Note from the editor. In accordance with WHO editorial policy the text reproduced below does not include tracked changes. Changes from the current monograph are indicated by insert and delete in the working document available at the above-mentioned web address.]
C^sub 16^H^sub 13^N^sub 3^O^sub 3^
Relative molecular mass. 295.3
Chemical name. Methyl 5-benzoyl-2-benzimidazolecarbamate; methyl (5-benzoyl-1H-benzimidazol-2-yl)carbamate; CAS Reg. No. 31431-39-7.
Description. A white or almost white powder.
Solubility. Practically insoluble in water, dilute mineral acids and ethanol (~750 g/L) TS ; freely soluble in formic acid (~1080 g/L) TS.
Category. Anthelmintic.
Storage. Mebendazole should be kept in a well-closed container, protected from light.
Additional information. Mebendazole exhibits polymorphism.
Requirements
Definition. Mebendazole is polymorph C, the crystal form of mebendazole RS. Mebendazole contains not less than 99.0% and not more than 101.0% of mebendazole (C^sub 16^H^sub 13^N^sub 3^O^sub 3^), calculated with reference to the dried substance.
Identity test
Carry out the examination as described...