Spironolactone has a molecular formula of C24H32O4S and a molecular weight of 416.57. It is a steroidal anti-mineralocorticoid drug and also a potassium-sparing diuretic. It has unique anti-aldosterone activity. The main mechanism of action of this type of drug is to regulate the balance of electrolytes and water by antagonizing the mineralocorticoid receptors in the human body, especially the aldosterone receptors.
Its core utility lies in the design of a variety of health conditions, including the treatment of primary aldosteronism, the relief of edema symptoms, the regulation of hypertension, and the prevention of hypokalemia.
| Items | Standard | Results |
| Ref Standard | According with Ph.Eur.9.8 /USP40 | |
| Assay | 97.5% - 102.0%(Ph.Eur.) | 100.90% |
| 97.0% - 103.0%(USP) | 99.40% | |
| Appearance(Ph. Eur.) | a White or yellowish-white powder | White powder |
| Solubility (Ph. Eur.)(annual) | Practically insoluble in water, soluble in ethanol(96 per cent) | Complies |
| Particle Size(In-house) | 95% not more than 20 microns | Complies |
| Specific Optical Rotation | -41°to -46°(Ph.Eur.) | -44.7° |
| -41° to- 45°(USP) | -43.3° | |
| Loss on Drying | ≤ 0.5%(Ph.Eur.) | 0.02% |
| ≤ 0.5%(USP) | 0.07% | |
| Sulphated Ash(Ph. Eur.) | ≤0.1% | 0.00% |
| Related Substances(Ph. Eur.) | Impurity A≤0.2% | ND |
| Impurity F≤0.3% | ND | |
| Impurity C≤0.2% | ND | |
| Impurity D≤0.15% | 0.05% | |
| Impurity E≤0.3% | ND | |
| Impurity I≤0.5% | ND | |
| Any Unspecified Impurity ≤0.10% | Complies | |
| Total ≤0.7% | 0.11% | |
| Ordinary Impurities | ≤2.0%(USP) | Complies |
| Free Thiol Compounds(Ph.Eur.) | a blue colour develops | Complies |
| Free Mercapto Compounds(USP) | ≤0.10ml | Complies |
| Methanol | ≤3000ppm | 6ppm |
| Tetrahydrofuran | ≤720ppm | ＜LOD(0.4ppm) |
| DMF | ≤880ppm | ＜LOD(43ppm) |
| Conclusion | Complies |
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