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Spironolactone 52-01-7

Spironolactone 52-01-7

EP8, USP38
  • Product Details

Product Information


Product name

Spironolactone

Molecular Formula

C24H32O4S

Molecular Weight

416.57

CAS No.

52-01-7

Quality Standard

99% up, medical grade

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. , The effect is poor.

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