Betamethasone Beta steroid
Item |
Standard |
Result |
Characters |
A white powder,odorless |
Conforms |
Identification |
The infrared absorbance spectrum is concordant with the reference spectrum |
Conforms |
The principal spot in the chromatogram obtained with the test solution is similar in position, color in daylight,fluorescence in UV light at 365nm and size to the principal spot in the chromatogram obtained with reference solution |
||
Specification optical rotation |
+114º- +122º |
+117.5º |
Color value |
Exhibits a max.absorption at 240nm,the absorbance is about 0.37-0.40 |
Exhibits a max.absorption at 239.40nm,the absorbance is about 0.397 |
Residual solvents |
Acetone≤5000ppm |
108ppm |
Methanol≤3000ppm |
307ppm |
|
Dichloromethane≤600ppm |
63pm |
|
DMF≤880ppm |
No detected |
|
Acetic Ester≤5000ppm |
106ppm |
|
Glacial Acetic Acid ≤5000ppm |
No detected |
|
Related substances
|
Any impurity≤1.0% >0.5% Impurity not more than one Total impurities≤1.0% |
Any impurity<1.0% No impurity more than0.5% 0.68 |
Sulphated ash |
≤0.1% |
0.05 |
Loss on drying |
≤0.5% |
0.10 |
Assay |
98.5-103.0% |
99.2% |
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