Description
Technical Parameters
|
Items |
Standard |
|
Appearance |
White or off-white crystallize powder |
|
Identification(HPLC) |
HPLC:Sample and standard exhibit the same retention time |
|
Solubility |
Freely Soluble in Ethanol Freely Soluble in Dichloromethane Slightly Soluble in water |
|
Water |
NMT 0.50%(By Karl Fischer) |
|
Melting range |
118.0℃-129.0℃ |
|
Heavy metals |
NMT 10ppm |
|
Residual Solvent |
Methanol NMT 1500ppm TBME NMT 2500ppm Dichloromethane NMT 600ppm Tetrahydrofuran NMT 720ppm Toluene NMT 60ppm |
|
Enantiomer |
NMT 0.10%(By HPLC) |
|
Related substance |
Single impurity NMT 0.10% Total impurities NMT 1.0% |
|
Assay |
98.0%-102.0% |
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