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東康源120511-73-1質(zhì)檢單/質(zhì)量標(biāo)準(zhǔn)/COA

Product	Anastrozole
Batch No:	181201	Mfg.Date	2018-12-01	Analysis Date:	2018-12-01
Quantity:	10kg	CAS No.:	120511-73-1	Retest Date.:	2020-11-30
ANALYSIS		SPECIFICATIONS		RESULTS
Appearance		White to off-white crystalline powder		Conforms
Solubiltity		Very soluble in acetronitrile,freely soluble in methanol,in acetone,in alcohol,and in tetrahydrofuran		Conforms
Identification		IR HPLC		Conform with standard IR Conforms
Water		NMT 0.3%		0.1%
Residue on ignition		NMT 0.1%		Conforms
Heavy metals		NMT 10ppm		<10ppm
Related substances Related Compound B Related Compound C Related Compound D Related Compound E Individual unspecified impurity Total unspecified impurity Total impurities		NMT 0.2% NMT 0.2% NMT 0.1% NMT 0.1% NMT 0.1% NMT 0.1% NMT 0.5%		ND ND ND 0.05% 0.07% 0.08% 0.2%
Residual solvents Dichloromethane Chloroform Ethanol Cyclohexane Ethylacetate		NMT 0.06% NMT 0.006% NMT 0.5% NMT 0.08% NMT 0.5%		ND ND 0.07% ND 0.1%
Assay (on dry basis)		98.0%~102.0%		99.7%
Conclusion:complies with USP35
STORAGE		Cool and dry
SHELF LIFE		24 months

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