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Olmesartan medoxomil olmesartan medoxomil CAS:144689-63-4
Production name | Olmesartan medoxomil |
CAS No. | 144689-63-4 |
Appearance | White powder |
Molecular Formula | C29H30N6O6 |
Molecular Weight | 558.585 |
Assay | 99% |
Items | Specifications | Result |
Appearance | White or almost white, crystalline powder | White crystalline powder |
Solubility | Slightly soluble in methano/l; practically insoluble in water | Conforms |
Identification | IR: The IR spectrum is consistent with that obtained with the reference standard. | Conforms |
HPLC: The ratio of retention time of the major peak of the internal standard of the Sample solution corresponds to that of the standard solution, as obtained in the Assay. | Conforms | |
Water | NMT 0.5% | 0.04% |
Residue on ignition | NMT 0.1% | 0.04% |
Heavy metals | NMT 10ppm | Conforms |
Related substances | Olmesartan NMT 0.5% | Below disregards limit |
Olmesartan medoxomil related compound A NMT 0.1% | Not detected | |
Olefinic impurity NMT 0.6% | Below disregard limit | |
N-alkyl impurity NMT 0.1% | Not detected | |
Any other individual unidentified impurity NMT 0.1% | Below disregards limit | |
Total impurities NMT 1.3% | 0.08% | |
Residual solvents | Aceton/e NMT 5000ppm | 2352ppm |
Assay | 98.5%~101.5% (on anhydrous and solvent-free basis) | 100.6% |
Conclusion | The analysis results show that this batch of Olmesartan medoxomil conforms to USP.36 |
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