Fidaxomicin Fidaxomicin API
≥98.0%
Appearance White or off-white crystalline powder Identification HPLC :sample and standard exhibit the same rentention time IR: Sample spectrum corresponds to that of standrad spectrum Water ≤3.0% Heavy metals ≤20ppm Residual solvents Ethanol ≤5000ppm Ethyl acetate ≤500ppm Acetonitrile ≤410ppm Related substances Impurity A RRT≈0.83 ≤0.15% Impurity B RRT≈0.92 ≤0.15% Impurity C RRT≈1.08 ≤0.15% Single unknown impurity≤0.10% Total impurities≤1.0% Assay 98.0~102.0% (on anhydrous basis)
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