Spironolactone 52-01-7

EP8, USP38，99.95% up by HPLC, total impurities < 0.05%

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Product Information

Product name	Spironolactone
Molecular Formula	C24H32O4S
Molecular Weight	416.57
CAS No.	52-01-7
Quality Standard	99.95% up
Appearance	White powder

COA of Spironolactone

ITEMS	STANDARDS	RESULTS
Appearance (Ph.Eur.)	A white or yellowish-white powder	White powder
Solubility (Ph.Eur.)	Practically insoluble in water, soluble in ethanol (96%)	Complies
Identification
A. IR –spectrum (Ph.Eur.) A. IR –spectrum (USP) B. TLC (Ph.Eur.) B. UV absorption (USP) C. Colour reaction (Ph.Eur.) C. Precipitate reaction (USP)	Meet the requirement Meet the requirement Meet the requirement Meet the requirement Meet the requirement Meet the requirement	Complies Complies Complies Complies Complies Complies
Loss on drying (Ph.Eur.) (USP)	Not more than 0.5% Not more than 0.5%	0.24% 0.23%
Specific optical rotation (Ph.Eur.) (USP)	-41°~-46° -41°~-45°	-43.4° -44.3°
Sulphated ash (Ph.Eur.)	≤0.1%	0.02%
Related substances (Ph.Eur.)
Impurity A Impurity B Impurity C Impurity D Impurity E Impurity I Any unspecified impurity Total	≤0.2% ≤0.3% ≤0.2% ≤0.15% ≤0.3% ≤0.5% ≤0.10% ≤0.7%	N.D. N.D. N.D. N.D. N.D. 0.07% Complies 0.16%
Ordinary impurities (USP)	≤2.0%	Complies
Free thiol compounds (Ph.Eur.)	≤0.05mL	Complies
Free mercapto compounds (USP)	≤0.10mL	Complies
Chromium (Ph.Eur.)	≤50ppm	Complies
Assay HPLC (Ph.Eur.) HPLC (USP)	97.5%~102.0% 97.5%~103.0%	100.2% 99.8%
Residual solvent (In-house) Methanol Tetrahydrofuran DMF	≤3000ppm ≤720ppm ≤880ppm	56ppm ≤LOD (0.0046ppm) ≤LOD (0.23ppm)
Particle size (In-house)	95% ≤ 20 microns	Complies
Conclusion	Compiles with EP8/USP38

Usage

Function of Spironolactone

Spironolactone is a steroid and is a strong endogenous salt corticosteroid aldosterone. Spironolactone has a similar chemical structure to aldosterone. It competes with aldosterone in the epithelial cells of the cortical segment of the distal convoluted tubule and collecting duct to bind to the aldosterone receptor, thereby inhibiting the effect of aldosterone in promoting K-Na exchange. Increase the excretion of Na and Cl, play a diuretic effect, while K is retained. The drug has a weak diuretic effect, slow and lasting. After a period of continuous medication, its diuretic effect gradually weakened. At the same time, it has anti-androgen activity, which can selectively destroy the testis and adrenal microsomal cytochrome P450, thereby inhibiting the production of androgens in the gonads, and can compete with dihydrotestosterone for receptors in the target tissues, reducing the stimulation of androgens to the sebaceous gland.

1. Edema diseases: spironolactone is used in combination with other diuretics to treat edema diseases such as congestive edema, liver cirrhosis, ascites, and renal edema. The purpose is to correct the secondary aldosterone secretion associated with the above diseases, and to combat other diuretics The role of potassium excretion. It is also used for the treatment of idiopathic edema.

2. Hypertension effect: Spironolactone is an auxiliary drug for the treatment of hypertension.

3. Primary aldosteronism: Spironolactone can be used for the diagnosis and treatment of this disease.

4. Prevention of hypokalemia: Combination of spironolactone and thiazide diuretics can enhance the diuretic effect and prevent hypokalemia.

Clinically, spironolactone is used to treat refractory edema related to elevated aldosterone, so it is more effective for patients with cirrhosis and nephrotic syndrome, but for congestive heart failure unless secondary hyperaldosteronism is caused by sodium deficiency.

*Products under the patent are only for R&D use