Specifications EP6.0
Item | Standard(EP6.3) |
Appearance | A pale yellow powder |
Identification | Should comply with the IR spectrum |
Exhibits maximum absorption at 354nm | |
Clarity of solution | 5.0% w/v solution in DMF is clear |
Related Substances (Impurity A) | ≤0.10% |
Related Substances (Impurity B) | ≤0.10% |
Related Substances (Impurity C) | ≤0.05% |
Related Substances (Impurity D) | ≤0.05% |
Related Substances (Any other impurity) | ≤0.10% |
Related Substances (Total Impurities) | ≤0.3% |
Heavy metals | ≤20ppm |
Loss on drying | ≤0.5% |
Sulphated ash | ≤0.1% |
Assay,on anhydrous basis | 99.0%~101.0% |
Residual Solvents(Ethanol) | ≤5000ppm |
Residual Solvents(1,2-Xylene) | ≤2170ppm |