Betamethasone powder is one of the most widely used powerful corticosteroids. Its powder raw material is white to nearly white, odorless, crystalline powder, insoluble in water. In the international market, our company has previously passed FDA certification for many corticosteroid API products, and the products are sold to many countries and regions in Asia, America and Europe.
Glucocorticoid drugs have good anti-inflammatory effects and are used in the comprehensive treatment of certain infections.
It is a commonly used anti-inflammatory and anti-allergic drug in clinical practice and is often used in combination with other drugs.
In the published studies on the therapeutic effects of glucocorticoids, betamethasone is more commonly used, has high safety, and has more clinical medical evidence.
ITEMS | SPECIFICATIONS | RESULTS |
Appearance | White to almost white,odorless, crystalline powder | Conforms |
Identification | Complies with the stanard | Conforms |
Loss on drying | ≤0.5% | 0.08 % |
Residue on Ignition | ≤0.3% | 0.3% |
Specific on rotation | +118~ +126. | + 123.4 ° |
Melting point | 50 ℃ ~ 60 ℃ | 50 ℃ ~ 60 ℃ |
Sulphate ash | ≤0.1% | 0.05% |
Heavy metals | ≤ 20 ppm | < 20ppm |
Related substance | Total impurity ≤2.0%Single impurity ≤.20% | 0.41%0.12% |
Methanol | ≤ 3000 ppm | Conforms |
Ethylacetate | ≤ 3000 ppm | Conforms |
DMF | ≤ 3000 ppm | Conforms |
Acetone | ≤ 3000 ppm | Conforms |
Dichlormethane | ≤ 3000 ppm | Conforms |
Assay | 97.0~103.0% | 100.0 % |
Conclusiion | This product complied with the standard of EP 6 |
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