Dexamethasone Powder is a white or off-white crystalline powder, odorless. Calculated on a dry basis, its assay reaches 97.0% to 102.0%. Dexamethasone is an adrenal cortical hormone drug, and its anti-allergic, anti-inflammatory, and anti-shock effects are better than prednisone.
Other common corticosteroid APIs include some synthetic steroid compounds, such as hydrocortisone, betamethasone, prednisolone, etc.
Test Items | Standard | Test Results |
Appearance | white or almost white crystalline powder | Complies |
Solubility | Complies | Complies |
Identification | A、B Complies | Complies |
Specific optical rotation | +86 °~ +92° | +88.5° |
Loss on drying | ≤0.5% | 0.2% |
Related substances | Impurity B≤0.15% Impurity F≤0.15% Impurity J≤0.15% Impurity K≤0.15% Impurity G≤0.3% Unknown impurity≤0.1% Total impurities≤0.5% | 0.13% ND 0.01% ND ND 0.08% 0.48% |
Assay | 97.0~103.0% | 99.5% |
Conclusion | Complies with EP9.0 standard |
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Pregnenolone is a neurosteroid produced naturally by the human body, mainly synthesized in the adrenal glands, brain and gonadal organs.
Betamethasone powder is one of the most widely used powerful corticosteroids.