Appearance :White to light yellow crystalline powder Identification: Absorptivities at the wavelength of maximumabsorbance at 315±…
Appearance :White to light yellow crystalline powder
Identification:
Absorptivities at the wavelength of maximum absorbance at 315±2nm and 215±2nm.
The retention time of the major peak in the
chromatogram of the related substances
preparation coresponds to that in the
chromatogram of the standard preparation.
Chloride :≤ 0.04%
Loss on drying: ≤ 1.0%
Residue on ignition: ≤ 0.1%
Heavy metals: ≤ 0.002%
Impurity :≤ 0.1%
Total impurities :≤ 0.5%
Residual solvents:
Methanol: ≤ 0.3%
Ethanol: ≤ 0.5%
Formic acid: ≤ 0.5%
DMF: ≤ 0.088%
Assay :≥ 98.5%
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