Terbinafine HCl CAS NO.78628-80-5

Items	Standard		Results
Appearance	White or off-white powder		Complies
Identification	UV，IR		Complies
Solubility	Very slightly and slightly soluble in water, freely soluble in anhydrous ethanol and methanol, slightly soluble in acetone		Complies
Related Substances	Impurity B	≤0.1%	0.020%
	Single unknown impurity	≤0.05%	0.031%
	Total impurity	≤0.3%	0.079%
Loss on drying	≤0.5 %		0.07 %
Heavy metals	≤20mm		Complies
PH	3.0～4.5		3.98
Residue on ignition	≤0.10 %		0.03%
Assay	99～101 % (Titration)		99.82 %
Storage	Keep tightly closed, Store in cool and dry place
Determination	Complies with EP6 standard

Analyst : wangsulan Checker: Wangyuan Supervisor :Lihong

Identification
Name		Terbinafine hydrochloride
Synonyms		(E)-N-(6,6-Dimethyl-2-hepten-4-ynyl)-N-methyl-1-naphthalenemethanamine monohydrochloride

Molecular Structure

Molecular Formula		C₂₁H₂₅N^.HCl;C₂₁H₂₆ClN
Molecular Weight		327.90
CAS Registry Number		78628-80-5

Properties

Melting point		204-208 ºC