- Appearance: Yellow or pale yellow powder
Assay (Dried bases): 95.0%min.
Water: 5.0%max.
Specific optical rotation: +17.0deg to +25.0deg
PH: 4.0 to 5.0
Residue on ignition: 1.0%max.
Related substances
Anhydro-daptomycin: 2.5%max.
β-Isomer :0.5%max.
Hydrolysis impurity: 0.5%max.
Impurity 1: 0.75%max.
Impurtiy 2: 0.75%max.
Impurtiy 3: 0.75%max.
Any other impurity: 0.15%max.
Total impurities: 5.0%max.
Heavy metals: 30ppm max.
Detailed Introduction
