EzetiMibe; 1-(4-fluorophenyl)-3-[3-(4-fluorophenyl)-3-hydroxy-propyl]-4-(4-hydroxyphenyl)-azetidin-2 1-(4-fluorophenyl)-3-[3-(4-fluorophenyl)-3-hydroxy-propyl]-4-(4-hydroxyphenyl)-azetidin-2-one; 163222-33-1
Appearance |
White to off-white power |
Complies |
Solubility
|
Freely soluble in methanol, ethanol and acetone
|
Complies
|
Identification by IR
|
IR spectrum of the sample in KBr dispersion should concordant with Ezetimibe working standard |
Complies
|
Identification by HPLC
|
The retention time of the main peak in the chromatogram of the test preparation should match to that in the chromatogram of the standard preparation |
Complies
|
Specific optical rotation |
Between -25.0° and -34.0° -28.91°
|
-28.91° |
A) EZB-1 impurity B) Desfluro impurity C) Any other impurity D) Total impurity |
≤0.30% ≤0.50% ≤0.30% ≤1.0% |
Not Detected 0.18% 0.007% 0.19% |
Loss on Drying |
≤0.5% |
0.19%
|
Residue on ignition |
≤0.2% |
0.04%
|
Heavy metal |
≤20ppm |
Complies
|
Assay
|
98.0%-102.0% |
99.52%
|
Appearance |
White to off-white power |
Complies |
Solubility
|
Freely soluble in methanol, ethanol and acetone
|
Complies
|
Identification by IR
|
IR spectrum of the sample in KBr dispersion should concordant with Ezetimibe working standard |
Complies
|
Identification by HPLC
|
The retention time of the main peak in the chromatogram of the test preparation should match to that in the chromatogram of the standard preparation |
Complies
|
Specific optical rotation |
Between -25.0° and -34.0° -28.91°
|
-28.91° |
A) EZB-1 impurity B) Desfluro impurity C) Any other impurity D) Total impurity |
≤0.30% ≤0.50% ≤0.30% ≤1.0% |
Not Detected 0.18% 0.007% 0.19% |
Loss on Drying |
≤0.5% |
0.19%
|
Residue on ignition |
≤0.2% |
0.04%
|
Heavy metal |
≤20ppm |
Complies
|
Assay
|
98.0%-102.0% |
99.52%
|
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