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Details:
Appearance White to yellowish crystalline powder
Identification Infrared Absorption
The retention times of the Component B1a peak and the Component B1b peak in the chromatogram of the Assay preparation correspond to those in the chromatogram of the standard preparation
Specific rotation +132°~ +140°
Water ≤2.0%
Residue on ignition ≤0.1%
Heavy metals ≤10ppm
Residual solvents Acetonitrile ≤0.005%
Sum of all solvent≤0.5%
8a-oxo-B1a ≤0.5%
Related compounds Related compounds with relative retentions of 0.23,0.93, and 1.16 correspond to B1a peak≤1.0%
Impurity A ≤1.0%
Impurity E ≤1.0%
All other known impurities ≤0.5%
Total unknown impurities ≤1.0%
Total impurities ≤5.0%
Assay Component B1a ≥90.0%
Component B1a and Component B1b ≥95.0%