Name:Lrbesartan
CAS NO:138402-11-6
MF:C25H28N6O
Appearance:White to Off-white, crystalline powder
The detailed specifications are as below:
| Itemoftesting | InspectionStandard | Result |
| Appearance | WhitetoOff-white,crystallinepowder | Whitecrystallinepowder |
| Identification | Infraredabsorption:TheIRspectrumIsconsistentwiththatobtainedwithThereference | Conforms |
| TheretentiontimeofthemajorpeakInthechromatogramoftheAssayPreparationcorrespondstothatinthechromatogramoftheStandardpreparation,asobtainedintheAssay | ||
| Water | NMT0.5% | 0.31% |
| Limitofazide | NMT10ppm | Notdetected |
| Heavymetals | NMT0.002% | Conforms |
| Relatedcompounds | CompoundANMT0.2% | 0.02% |
| AnyotherimpurityNMT0.1% | 0.04% | |
| TotalimpuritiesNMT0.5% | 0.09% | |
| Residualsolvents(GC) | EthanolNMT5000ppm | 26ppm |
| TolueneNMT890ppm | 133ppm | |
| t-ButylmethyletherNMT5000ppm | Notdetected | |
| Assay(ontheanhydrousbasis) | 98.0~102.0% | 99.3% |
| Conclusion | TheanalysisresultsshowthatthisbatchofIrbesartanconformstoUSP. | |