Name:CarvedilolCAS:72956-09-3MF:C24H26N2O4Appearance: white crystalline powderQuality standard: EP5.0/BP
The detailed specifications are as below:
| Itemoftesting | InspectionStandard | Result | |
| Description | Whiteoralmostwhite,crystallinepowder.Slightlysolubleinalcohol,practicallyinsolubleinwateranddiluteacids(dilutehydrochloricacid.) | Conforms | |
| Identification | InfraredabsorptionspectrumcorrespondstothespectrumobtainedwithCarvedilolReferenceStandard. | Conforms | |
| TheretentiontimeofthemajorpeakinthechromatogramoftheAssaypreparationcorrespondstothatinthechromatogramoftheStandardpreparation,asobtainedintheAssay. | Conforms | ||
| Relatedsubstance | (1)ImpurityA(2)ImpurityB(3)ImpurityC(4)ImpurityD(5)ImpurityE(6)Anyotherimpurity(7)Totalimpurities | (1)≤0.10%(2)≤0.10%(3)≤0.02%(4)≤0.10%(5)≤0.10%(6)≤0.10%(7)≤0.50% | (1)0.01%(2)N.D.(3)N.D.(4)N.D.(5)0.01%(6)0.05%(7)0.12% |
| Lossondrying | Max0.5% | 0.1% | |
| Residueonignition | Max0.1% | <0.1% | |
| Heavymetals | Max10ppm | <10ppm | |
| Assay | 98.0~102.0%(driedsubstance) | 99.8% | |
| Residualnickel | Max10ppm | 1.3ppm | |
| Conclusion | ComplieswithUSPspecification | ||