Product name | Dexamethasone |
CAS No. | 50-05-2 |
Molecular Formula | C22H29FO5 |
Molecular Weight | 392.461 |
Quality Standard | 99% up by HPLC， USP38/BP2010/EP6 |
Appearance | White powder |
ITEMS | STANDARDS | RESULTS |
Appearance | White to almost white powder | White powder |
Identification | Infrared absorption: The IR spectrum is consistent with that obtained with the reference |
Conforms |
The retention time of the major peak in the chromatogram of the assay preparation corresponds to that in the chromatogram of the standard preparation, as obtained in the assay | Conforms |
Absorbance | NMT 0.02 | 0.003 |
Water | NMT2.0% | 0.56% |
Residue on ignition | NMT0.1% | 0.06% |
Heavy metals | NMT0.001% |
|
Related compounds (HPLC) | Compound A NMT1.0% | 0.49% |
Compound B NMT0.2% | 0.08% |
Compound C NMT0.1% | Undetected |
Any other individual impurity NMT0.1% (excluding compound A ) | 0.04% |
Total impurities NMT0.3% (excluding compound A ) | 0.20% |
Residual solvents(GC) | Ethyl acetate NMT5000ppm | 2820ppm |
Dichloromethane NMT600ppm | Undetected |
Methanol NMT3000ppm | Undetected |
N,N-Dimethylformamide NMT880ppm | Undetected |
Assay | 98.0—102.0% | 99.2% |
Conclusion | The analysis results show that this batch of valsartan conforms to USP
|
Function of Dexamethasone
Dexamethasone, also known as flumethasone, flumethasone. Dexamethasone is a glucocorticoid. Its derivatives include hydrocortisone, prednisone, etc., and its pharmacological effects are mainly anti-inflammatory, anti-toxic, anti-allergic, and anti-rheumatic, and are widely used in clinical practice.
1. Anti-inflammatory effect: It can reduce and prevent the tissue's response to inflammation, thereby reducing the performance of inflammation. Hormones inhibit the accumulation of inflammatory cells, including macrophages and white blood cells, at the site of inflammation, and inhibit phagocytosis, the release of lysosomal enzymes, and the synthesis and release of inflammatory chemical mediators.
2. Immunosuppressive effects: including preventing or suppressing cell-mediated immune responses, delayed allergic reactions, reducing the number of T lymphocytes, monocytes, and eosinophils, and reducing the ability of immunoglobulin to bind to cell surface receptors , And inhibit the synthesis and release of interleukins, thereby reducing the transformation of T lymphocytes into lymphoblasts, and reducing the expansion of the primary immune response. It can reduce the passage of immune complexes through the basement membrane, and can reduce the concentration of complement components and immunoglobulins.
Dexamethasone is easily absorbed from the digestive tract. The plasma T1/2 is 190 minutes, and the tissue T1/2 is 3 days. After intramuscular injection of dexamethasone sodium phosphate or dexamethasone acetate, it reaches the blood within 1 hour and 8 hours, respectively. Peak drug concentration. The binding rate of dexamethasone to plasma protein is lower than that of other corticosteroids. Its anti-inflammatory activity of 0.75 mg is equivalent to 5 mg of prednisolone. In addition, as an adrenal cortex hormone drug, dexamethasone has stronger anti-inflammatory, anti-allergic and anti-toxic effects than prednisone, and has very light water and sodium retention and promotion of potassium excretion. It can be injected intramuscularly or intravenously on the pituitary and adrenal glands. Strong inhibitory effect.
