Spironolactone 52-01-7

Basic information 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.

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

Country: China (Mainland)
Business Type: Manufacturer
Market: Africa
Founded Year: 1987
Address: Floor 16, Huicheng Business Center, No. 839, Xiahe Rd., Siming Dist. Xiamen, Fujian, China
Contact: Sinoway Sinoway