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Entecavir monohydrate is a white or almost white powder that is practically insoluble in water and slightly soluble in methanol. It is defined as 2-Amino-9-[(1S,3R,4S)-4-hydroxy-3-(hydroxymethyl)-2-methylidenecyclopentyl]-1,9-dihydro-6H-purin-6-one monohydrate and contains between 98-102% of the anhydrous substance. Tests are conducted to verify the specific optical rotation and to check for impurities using liquid chromatography, with limits placed on unspecified impurities.

Author

Maria Luiza

Language

EN