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Terbinafine Hydrochloride鹽酸特比萘芬78628-80-5出口標(biāo)準(zhǔn)廠家質(zhì)檢

Product Name	Terbinafine hydrochloride	Batch No.	20181202
MFG. Date	Dec 17,2018	Exp. Date	Dec 16,2021
Quantity	10g	Standard	EP7.0
ITEMS	SPECIFICATIONS		RESULTS
Appearance	White or almost white powder		Complies
Solubility	Very slightly or slightly soluble in water , freely soluble in anhydrous ethanol and in methanol , slightly soluble in acetone		Complies
Identification	A: IR the infrared absorption spectrum exhibits maximam only at the same wavelengths as that of the standard sample B: It gives reaction of Chlorides		Complies
Related Substances	A: impurity B NMT 0.1% B: any other impurity NMT 0.1% C: total of impurities NMT 0.3%		0.004% Complies 0.08%
Loss on drying	＜0.5%		0.19%
Sulphated ash	＜0.1%		0.02%
Assay	99.0～101.0%（dried substance）		99.83%
Conclusion	All analytical methods and results conform to the requirement of EP7.0

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