Superiority:
Appearance Pale yellow crystalline powder
Assay,HPLC 98.5-101.5%
Solubility Soluble in water
Identification UV: the UV absorption of 0.001% solution in water exhibits a max at about 228nm
IR:IR Spectrum in potassium bromide dispersion of sample should beconcerdant with that of working standard spectrum
HPLC: Retention time of the sample should be concordant to the retention time of workting standard.
Element analysis:Carbon, Nitrogen, Hydrogen
Melting point 121℃
Specific optical rotation +39?
Isomer 75%min
Residue on ignition 0.1% max
Heavy metals 20ppm max
Water 1.0% max
Related substances Single impurity: 0.5% max
Total impurity: 1.0% max
Details:
Appearance Pale yellow crystalline powder
Assay,HPLC 98.5-101.5%
Solubility Soluble in water
Identification UV: the UV absorption of 0.001% solution in water exhibits a max at about 228nm
IR:IR Spectrum in potassium bromide dispersion of sample should beconcerdant with that of working standard spectrum
HPLC: Retention time of the sample should be concordant to the retention time of workting standard.
Element analysis:Carbon, Nitrogen, Hydrogen
Melting point 121℃
Specific optical rotation +39?
Isomer 75%min
Residue on ignition 0.1% max
Heavy metals 20ppm max
Water 1.0% max
Related substances Single impurity: 0.5% max
Total impurity: 1.0% max