Spironolactone

Product Details

Name:Spironolactone

CAS No.:52-01-7

EINECS:200-133-6

MF:C24H32O4S

MW:416.57

MP:207-208 °C(lit.)

Purity:99% min

Introduction

It is a synthetic 17-lactone drug that is a renal competitive aldosterone antagonist in a class of pharmaceuticals called potassium-sparing diuretics, used primarily to treat heart failure, ascites in patients with liver disease, low-renin hypertension, hypokalemia, secondary hyperaldosteronism (such as occurs with hepatic cirrhosis), and Conn's syndrome (primary hyperaldosteronism). On its own, spironolactone is only a weak diuretic because its effects target the distal nephron (collecting tubule), where urine volume can only be slightly modified; but it can be combined with other diuretics to increase efficacy. About one person in one hundred with hypertension has elevated levels of aldosterone; in these persons, the antihypertensive effect of spironolactone may exceed that of complex combined regimens of other antihypertensives. Due to its antiandrogen effect, it can also be used to treat hirsutism. It is also used for treating hair loss and acne in women, and can be used as a topical medication for treatment of male baldness. It is commonly used to treat symptoms of polycystic ovary syndrome (PCOS) such as excess facial hair and acne. It can also cause gynecomastia in males and should never be given with potassium supplementation for fear of the development of hyperkalemia.

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.)	Meet the requirement	Complies
A. IR –spectrum (USP)	Meet the requirement	Complies
B. TLC (Ph.Eur.)	Meet the requirement	Complies
B. UV absorption (USP)	Meet the requirement	Complies
C. Colour reaction (Ph.Eur.)	Meet the requirement	Complies
C. Precipitate reaction (USP)	Meet the requirement	Complies
Specific optical rotation	-41°~-46°	-42.8°
(Ph.Eur.)	-41°~-45°	-42.9°
(USP)
Sulphated ash (Ph.Eur.)	≤0.1%	0.00%
Related substances (Ph.Eur.)
Impurity A	≤0.2%	N.D.
Impurity B	≤0.3%	N.D.
Impurity C	≤0.2%	N.D.
Impurity D	≤0.15%	N.D.
Impurity E	≤0.3%	N.D.
Impurity I	≤0.5%	0.05%
Any unspecified impurity	≤0.10%	Complies
Total	≤0.7%	0.13%
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	97.5%~102.0%	100.90%
HPLC (Ph.Eur.)	97.5%~103.0%	99.60%
HPLC (USP)
Residual solvent (In-house)	≤3000ppm	90ppm
Methanol	≤720ppm	≤LOD (0.0046ppm)
Tetrahydrofuran	≤880ppm	≤LOD (0.23ppm)
DMF
Particle size (In-house)	95% ≤ 20 microns	Complies
Conclusion	Compiles with EP7/USP35

Packaging & Shipping

Package: 25kgs/drum, plastic-bag inside, aluminum foil bag or fiber drum outside.

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Spironolactone

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