We use cookies to help provide you with the best possible online experience. Please read our Privacy Policy for information about which cookies we use and what information we collect on our site. By continuing to use this site, you agree that we may store and access cookies on your device.
One More Step to Finalize Your Registration
An activation link has been sent to your email address.
Please check the email and activate your account now. It might take few minutes to get the email.
If you did not find it, please check your spam box.
Having problem receiving the email? Send again
Still cannot receive? Contact us
Email :PharmaSources@imsinoexpo.com
Whatsapp :+86-13621645194
Main Sales Markets: North America,Central/South America,Western Europe,Eastern Europe,Australasia,Asia,Middle East
Monthly Production Capacity: 1000kg
Packaging Information: 25kg/drum 1kg/bottle
Delivery Lead Time: 7 days after payment
Sample Provided: yes
Payment Terms: L/L
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.