Test Items		Specification	Test results

Characters		Yellow crystalline powder	Yellow crystalline powder
Identification	Melting point	186.0-189.0 ℃	187.0-188.0 ℃
	IR	Infrared absorption spectrophotometry accord with the nifuratel CRS.	Meet the specification
	Chemical reaction	Positive reaction	Meet the specification
	UV	The most absorption at 260nm and 365nm	Meet the specification
Colour of solution		NMT No.5 solution standard	Meet the specification
PH		5.5-7.0	6.54
Related substances		Any impurity ≤0.2%	0.03%
Related substances		Total impurity ≤1.0%	0.07%
Loss on drying		≤0.5%	0.06%
Sulphated ash		≤0.1%	0.02%
Assay		98.5%~101.5%	100.4%
Residual Solvents		DMF ≤880ppm	Not detected
		Methanol≤3000ppm	Not detected
		Dichloromethane≤600ppm	Not detected

Nifuratel powder

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