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Dexmedetomidine Hydrochloride
Dexmedetomidine hydrochloride
CAS NO.145108-58-3
M.F: C13H17ClN2
M.W:236.74048
Appearance:White or almost white crystalline

TEST SPECIFICATIONS RESULTS
Appearance White or off-white crystalline powder, hygroscopic Conforms
Melting point 155℃~158℃ 156℃~158℃
Solubility Conforms Conforms
Identification    
(1) Weight 5mg of sample, dissolve it in 5ml of water, add several drop of Dragendorff’s reagent, gamboge precipitate is formed Conforms
(2) By IR, To match with working standard Conforms
(3) Test for chlorides. Reponds to the test for Chlorides. Conforms
pH 3.5-4.5 4.24
Clarity and Color of Solution Conforms Conforms
Specific Rotation +51.0°~+54.0° +52.6°
Related Substances ≤1.0% 0.10%
Levomedetomidine Hydrochloride ≤1.0% 0.049%
Loss on drying ≤1.0% 0.07%
Residue on Ignition ≤0.1% 0.05%
Heavy Metal ≤10ppm Conforms
Residual solvent Methanol≤0.3%
Acetone ≤0.5%
Dichloromethane≤0.06%
Ethanol ≤0.5%
Ethyl acetate ≤0.5%
0.01%
Not detected
Not detected
0.022%
Not detected
The largest single unknown impurities ≤0.1% <0.1%
Assay ≥99.0% (anhydrous, containing  Dexmedetomidine Hydrochloride) 99.76%