Product Description

Item		Specification			Result
Characters
Appearance		White or almost white, crystalline powder			White crystalline powder
Solubility Test		Free soluble in methanol, soluble in ethanol,sparingly soluble in acetone, acetonitrile and chloroform and very slightly soluble in water.			Complies
Identification
UV		The UV absorption of 0.001% solution in HCl exhibits a max at about 222nm and 283nm.			Complies
HPLC		Should be concordant to the retention time of working standard.			Complies
Tests
Melting Point		136°C – 141°C			136.8°C – 138°C
Specific Rotation (on dried basisi, 1%solution in chloroform)		-48~-54°			-51.15°
Loss on Drying (Dry it at 80℃ in vacuum till a constant weight)		NMT 0.5%			0.13%
Residue on ignition		NMT 0.1%			0.08%
Heavy metals		NMT 10ppm			Less than 10ppm
Related substances(by HPLC) Max single impurity Total impurity		NMT 0.5% NMT 1.0%			0.10% 0.19%
Assay (By Titrate)		NLT 98.5%			99.98%
Conclusion	It complies with the requirements of Mediking Standard.
Tester:			Checker:	Person in charge: