Mometasone furoate CAS 83919-23-7
Items | Standard | Results |
Description | White or almost white powder | almost white powder |
Solubility | Practically insoluble in water,soluble in acetone and methylene chloride slightly soluble in ethanol (96%). | complies |
Melting point | About 220℃(with decompostion) | 220.5~223.5℃ |
Identification | ||
A) By IR | Infrared absorption spectrum should be concordant with working standard. | complies |
B) By HPLC | The retention time of major peak in the chromatogram of the assay preparation
corresponds to that of the standard preparation both relative to the internal standard, as obtained in the assay. |
complies |
Specific optical rotation | +50°~+55° | +51.0° |
Related substance (By HPLC) | ||
Any other impurity | Not more than 0.3% | 0.2% |
Total impurities | Not more than 0.6% | 0.3% |
Loss on drying | max.0.5% | 0.20% |
Assay(UV) | Not less than 97.0% not more than 103.0%. | 99.6% |
Partical Size | 100% not more than 20 Micron | complies |
Residual Solvent | ||
Methanol | not more than3000ppm | complies |
Ethyl acetate | not more than 5000ppm | complies |
Methylene chloride | not more than 600ppm | complies |
Conclusion: The product complies with the requirements of EP10.0 Standard. |