Dothiepin hydrochloride CAS NO.897-15-4

Item	Standard		Test Results
Identification	A.H-NMR:Comply with the structure		Complies
	B.LC-MS:Comply with the structure		Complies
	C.The IR :Comply with the reference standard;		Complies
	D.HPLC-ESI-MS		Complies
Crystallinity	meets the requirements.		Complies
pH value	3.0~4.5		4.3
Optical ratation	-128 to -121		-123
Loss of Drying	≤0.5%		0.28%
Sul. ash	≤0.1%		0.06%
HPLC	Impurity A, B, C, D, E: for each impurity	≤0.2%	Complies
	Unspecified impurities: for each impurity	≤0.1%	Complies
	Total Impurities	≤0.3%	0.15%
Assay	98.5~101.0%		100.1%
Microbiological Analysis
Total plant count	<1000cfu/g		Complies
Yeast and Moulds	<100cfu/g		Complies
E. Coli.; Salmonella; S.aureus	Absent		Negative
Storage	Preserve in well-closed, light-resistant and airtight containers.		Complies