Abiraterone acetate CAS NO.154229-18-2

Product Details

items	specifications	results
appearance	white to almost white powder	conforms
identification	ir: sample ir spectrum corresponds with that of the standard. hplc: the rt of major peak of the test solution corresponds to that of the standard solution	conforms conforms
specific rotation	-45^。～ -55^。	-50.7^。
clarity of solution	nmt ref.susp.i (1% in acetone)	conforms
colour of solution	nmt ref.solutioon by₅(1% in acetone)	conforms
related substance	ac.1352: ≤0.1% n/1501: ≤ 0.1% n#1504: ≤ 0.3% largest unspecified impurity: ≤ 0.1% total impurities: ≤0.5%	nd nd 0.02% 0.01% 0.05%
residual solvents	ethanol : ≤ 5000ppm	nd
	acetone: ≤ 5000ppm	37ppm
	toluene: ≤ 890ppm	nd
	actonitrile: ≤ 410ppm	nd
	2,6-dimethylpridine: ≤ 400ppm	nd
	benzene: ≤ 2ppm	＜2ppm
	mesityloxide: ≤ 2ppm	＜2ppm
sulphated ash	≤0.1%	0.02%
heavy metals	≤10ppm	conforms
loss on drying	≤0.5%	0.08%
assay(on drying basis)	98.0% ～ 102.0%	99.7%

items	specifications	results
appearance	white to almost white powder	conforms
identification	ir: sample ir spectrum corresponds with that of the standard. hplc: the rt of major peak of the test solution corresponds to that of the standard solution	conforms conforms
specific rotation	-45^。～ -55^。	-50.7^。
clarity of solution	nmt ref.susp.i (1% in acetone)	conforms
colour of solution	nmt ref.solutioon by₅(1% in acetone)	conforms
related substance	ac.1352: ≤0.1% n/1501: ≤ 0.1% n#1504: ≤ 0.3% largest unspecified impurity: ≤ 0.1% total impurities: ≤0.5%	nd nd 0.02% 0.01% 0.05%
residual solvents	ethanol : ≤ 5000ppm	nd
	acetone: ≤ 5000ppm	37ppm
	toluene: ≤ 890ppm	nd
	actonitrile: ≤ 410ppm	nd
	2,6-dimethylpridine: ≤ 400ppm	nd
	benzene: ≤ 2ppm	＜2ppm
	mesityloxide: ≤ 2ppm	＜2ppm
sulphated ash	≤0.1%	0.02%
heavy metals	≤10ppm	conforms
loss on drying	≤0.5%	0.08%
assay(on drying basis)	98.0% ～ 102.0%	99.7%