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CAS NO.107753-78-6
Items |
Standard |
Results |
Description | Off-white to pink powder | Light pink powder |
Solubility |
Freely soluble in methanol and ethanol,practically insoluble in acetonitrile | Complies |
Identification | Retention time of the sample should be concordant to the retention time of working standard | Complies |
IR absorption spectrum of the sample must be concordant with that of a similar preparation of montelukast sodium working standard /reference standard. | Complies | |
Loss on drying | ≤1.0% | 0.35% |
Sulphated Ash | ≤0.2% | 0.04% |
Heavy metals | ≤20ppm | <20ppm |
Relative substances (HPLC) |
Total impurity:≤1.0% | 0.8% |
Assay(on dried basis) | 98.0% ~ 102.0% | 99.5% |
Conclusion:It complies to prescribed enterprise standard |