Dexmedetomidine hydrochloride
CAS NO.145108-58-3
M.F: C13H17ClN2
M.W:236.74048
Appearance:White or almost white crystalline
The detailed specifications are as below:
| TEST | SPECIFICATIONS | RESULTS |
| Appearance | Whiteoroff-whitecrystallinepowder,hygroscopic | Conforms |
| Meltingpoint | 155℃～158℃ | 156℃～158℃ |
| Solubility | Conforms | Conforms |
| Identification | ||
| （1） | Weight5mgofsample,dissolveitin5mlofwater,addseveraldropofDragendorff’sreagent,gambogeprecipitateisformed | Conforms |
| （2） | ByIR,Tomatchwithworkingstandard | Conforms |
| （3） | Testforchlorides.RepondstothetestforChlorides. | Conforms |
| pH | 3.5-4.5 | 4.24 |
| ClarityandColorofSolution | Conforms | Conforms |
| SpecificRotation | +51.0°～+54.0° | +52.6° |
| RelatedSubstances | ≤1.0% | 0.10% |
| LevomedetomidineHydrochloride | ≤1.0% | 0.049% |
| Lossondrying | ≤1.0% | 0.07% |
| ResidueonIgnition | ≤0.1% | 0.05% |
| HeavyMetal | ≤10ppm | Conforms |
| Residualsolvent | Methanol≤0.3％ Acetone≤0.5％ Dichloromethane≤0.06％ Ethanol≤0.5％ Ethylacetate≤0.5％ | 0.01% Notdetected Notdetected 0.022% Notdetected |
| Thelargestsingleunknownimpurities | ≤0.1% | ＜0.1% |
| Assay | ≥99.0%(anhydrous,containingDexmedetomidineHydrochloride) | 99.76% |