Superiority:
Appearance White to yellowish-white powder
Very soluble in ethanol or chloroform; soluble in water and practically insoluble in ethyl ether
Identification (1) IR
(2) HPLC
Water 5.0% max
Residue on ignition 0.2% max
Heavy metals 20ppm max
Methyl benzenesulfonate 0.01% max
Toluene 890ppm(ICH) max
Chromatographic purity (1) Laudanosine: 0.5% max
(2) Any other individual impurity 1.0% max
(3) Total impurities 3.5% max
Isomer ratio (1) trans-trans isomer 5.0%~6.5%
(2) cis-trans isomer 34.5%~38.5%
(3) cis-cis isomer 55.0%~60.0%
Assay 96.0%~102.0%
Residual solvents (1) Dichloromethane 600ppm max
(2) Acetonitrile 410ppm max
(3) Ethyl ether 5000ppm max
Details:
Appearance White to yellowish-white powder
Very soluble in ethanol or chloroform; soluble in water and practically insoluble in ethyl ether
Identification (1) IR
(2) HPLC
Water 5.0% max
Residue on ignition 0.2% max
Heavy metals 20ppm max
Methyl benzenesulfonate 0.01% max
Toluene 890ppm(ICH) max
Chromatographic purity (1) Laudanosine: 0.5% max
(2) Any other individual impurity 1.0% max
(3) Total impurities 3.5% max
Isomer ratio (1) trans-trans isomer 5.0%~6.5%
(2) cis-trans isomer 34.5%~38.5%
(3) cis-cis isomer 55.0%~60.0%
Assay 96.0%~102.0%
Residual solvents (1) Dichloromethane 600ppm max
(2) Acetonitrile 410ppm max
(3) Ethyl ether 5000ppm max