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CAS 86347-15-1/CAS 106807-72-1 Medetomidine Hydrochloride | ||
Product Name | Medetomidine Hydrochloride | |
Appearance | White powder | |
CAS | 86347-15-1 / 106807-72-1 | |
MF | C13H17ClN2 | |
Purity | 99% | |
Storage | Keep in cool ＆ dry place,stay away from strong light and heat | |
Shelf Life | 24 months | |
TEST | SPECIFICATIONS | RESULTS |
Appearance | White or off-white crystalline powder, hygroscopic | Conforms |
Identification | ||
A:IR | The infra-red spectrum should meet with the spectrum of reference substance. | Conforms |
B:The retention time | the retention time of the major peak of the sample solution should correspond to that of the system suitability solution,as obtained in the test for Enantiomeric purity . | Conforms |
C:General,chloride | Should meet the requirements | Conforms |
Organic Impurities | Hydroxymedetomidine≤ 0.1% N-Benzyl Hydroxymedetomidine≤ 0.1% Ethylmedetomidine≤ 0.1% N-Benzyl medetomidine≤ 0.1% N-Benzyl Vinyl analog≤ 0.1% Any other individual impurity ≤ 0.1% Total Impurities ≤ 0.3% | Absent Absent Absent Absent Absent 0.026% 0.043% |
Levomedetomidine Hydrochloride | ≤1.0% | 0.012% |
Loss on drying | ≤1.0% | 0.10% |
Residue on Ignition | ≤0.1% | 0.04% |
Heavy Metal | ≤20ppm | Conforms |
Residual solvent | Methanol≤0.3％ | N.D. |
Ethanol≤0.5％ | 0.003% | |
Acetone≤0.5％ | 0.0083% | |
Ethyl acetate≤0.5％ | N.D. | |
Tetrahydrofuran≤0.072％ | N.D. | |
Dichloromethane≤0.06％ | N.D. | |
Assay | 98.0-102.0% (anhydrous, containing Dexmedetomidine Hydrochloride) | 99.80% |
Solubility | Freely soluble in water | Conforms |
Bacterial Endotoxin | Not more than 10 EU per mg | Conforms |
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