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 | ||
