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Tests	Specification	Results
Appearance	Yellow crystalline powder	Yellow crystalline powder
Melting Point	60.0-62.0°C	60.8℃
Identification	HPLC: The liquid phase detection spectrum is consistent with the standard	Complies
Identification	IR: Absorption spectrum complies with Reference Standard	Complies
Specific rotation	-1.0°~+1.0°	Complies
Loss on drying	Not more than 0.2%	0.04%
Residue on ignition	Not more than 0.1%	0.07%
Heavy metals	Not more than 10ppm	Complies
Residual solvents	Ethanol; Not more than 0.5%	ND
	Cyclohexane; Not more than 0.388%	0.08%
	Ethyl Acetate; Not more than 0.5%	0.02%
	Toluene; Not more than 0.089%	ND

Test items	In-house Standard	Test results
Description	White crystals or crystalline powder	Conforms
Identification	Infrared absorption	Conforms
Solubility	Almost insoluble in water, almost insoluble in 96% ethanol and ether	Conforms
Assay	99.0~101.0%	99.50%
Loss on drying	≤12.0%	10.20%
Residue on ignition	≤0. 10%	0.08%
pH	2.2~3.0	2.7
Chloride	≤100ppm	＜100ppm
Individual impurities	≤0.1%	＜0.1%
Total impurities	≤0.3%	＜0.3%
Heavy metals	≤20ppm	＜20ppm
Lead	≤1ppm	＜1ppm
Cadmium	≤0.5ppm	＜0.5ppm
Mercury	≤0.1ppm	＜0.1ppm
Arsenic	≤1ppm	＜1ppm