Terbinafine hydrochloride

CAS No. 78628-80-5
Other Names Terbinafine hcl
MF C12H25N HCl
EINECS No. 245-385-8
Place of Origin Zhejiang, China (Mainland)
Type Antibiotic and Antimicrobial Agents

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Terbinafine hydrochloride Details

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Item	Specification

Appearence	White or almost white powder
Loss on drying	No more than 0.5%
Sulphated ash	No more than 0.1%
Related substance	Impurity B is not more than 0.15%
	Impurity E is not more than 0.05%
	Single unspecified impurity is not more than 0.01%
	Total impurity is not more than 0.3%
Microbiology limit	Aerobic bacteria not more than 1000/g
	Total amount of fungi not more than 100/g
	Escherichia coli: none
Assay	>99.0%
conclusion	Comply with EP6

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