BP2012,EP8.0
Appearance White or yellowish-white powder
Solubility Very slightly soluble in water,
slightly soluble in alcohol.
•Identification
A: Melting point
B: Specific absorbance
C: IR-spectrum
D: Chemical reaction
199-203℃
Max.287nm: 240-250
Complies with reference spectrum
Green fluorescence at 365nm
Appearance of solution Not more intensely colored than
Reference Solution BY7
Related substances
Method A by HPLC Impurity F≤0.1%
Any single impurity≤0.1%
Total impurities≤0.2%
Method B by HPLC Any single impurity≤0.1%
Total impurities≤0.2%
Heavy metals ≤20ppm
Residual methanol ≤3000ppm
Residual DMSO ≤5000ppm
Residual acetic acid ≤5000ppm
Impurity K(aniline) by GC ≤5ppm
Loss on drying ≤1.0%
Sulphated ash ≤0.1%
Assay 98.5-101.0%