Nifuroxazide

Impurity A: Maximum 0.05%
Solubility: Practically insoluble in water, slightly soluble in ethanol(96%), practically insoluble in methylene chloride
Identification: Infrared absorption spectrophorometry complies with nifuroxazide CRS.
mpurity E: not more than 0.3%
Impurity B: not more than 0.1%
Impurity C: not more than 0.1%
Impurity D: not more than 0.1%
Unspecified impurities: not more than 0.1%
Sum of impurities other than E: not more than 0.5%
Disregard limit: not more than 0.05%
Heavy metals: Maximum 20ppm
Loss on drying: Maximum 0.5%
Sulphated ash: Maximum 0.1%

China