Basic information of Spironolactone 52-01-7
Product Name: Spironolactone
Molecular Formula: C24H32O4S
Molecular Weight: 416.57
CAS No .: 52-01-7
Appearance: White powder
Specifications: EP8/USP38
Usage of Spironolactone 52-01-7
Treat for High blood pressure
Treat for primary hyperaldosteronism.
Treat for Hypokalemia (Potassium deficiency
Severe heart failure
Edema (fluid retention) from various conditions, including Congestive edema; Liver cirrhosis ascites; renal edema
As cosmetic, Spironolactone have an effect in hair grow.
COA of Spironolactone 52-01-7
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
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