Description
Product Name | Eprosartan Mesylate | ||
Reference | USDMF26230 | ||
Test Items | Specifications | Results | |
Appearance | White to almost white crystalline powder | Almost white crystalline powder | |
Identification | 1) The infrared absorption spectrum of the substance to be examined is concordant with that obtained by Eprosartan Mesylate reference standard | Conform | |
2) The retention time of the major peak in the chromatogram of the Test solution corresponds to that in the chromatogram of the Standard solution, as obtained in the Assay. | Conform | ||
Loss on drying | ≤0.5% | 0.1% | |
Residue on ignition | ≤0.1% | <0.1% | |
Heavy metals | ≤0.001 % | <0.001% | |
Related substances (HPLC) | purity A≤0.13% | <LOQ(LOQ:0.05%) | |
Any unspecified Impurity≤0.10% | <LOD(LOD:0.02%) | ||
Total impurities≤1.0% | <LOQ | ||
Residual solvents(GC) | Ethyl acetate≤5000 ppm | 1233ppm | |
Ethanol≤5000 ppm | 293ppm | ||
Acetic acid≤5000 ppm | 3667ppm | ||
Assay (HPLC) | 98.0%~102.0% (Dried substance) | 99.2% | |
Conclusion | Complies with USDMF26230 |