Item | Specification |
Appearance | White or almost white, hygroscopic powder |
Identification | IR spectrum of sample corresponds to that of reference substance |
The retention time of the major peak of the sample solution corresponds to that of the standard solution, as obtained in the Assay | |
Water | ≤7.0% |
Residue on ignition | ≤0.1% |
Heavy metals | ≤20ppm |
Related substance | |
Impurity A | ≤2.0% |
Impurity B | ≤2.0% |
Impurity C | ≤1.5% |
Impurity D | ≤1.5% |
Any other individual impurity | ≤1.0% |
Total impurities | ≤4.0% |
Disregard limit | 0.2% |
Assay (anhydrous and solvent-free basis) | 96.0%~102.0% |
Residual solvents | |
Methanol | ≤3000ppm |
Acetone | ≤5000ppm |
Toluene | ≤890ppm |
Methylene chloride | ≤600ppm |
Dioxane | ≤380ppm |