Specifications

CAS No.:

52-01-7

Other Names:

Spirolactone

MF:

C24H32O4S, C24H32O4S

EINECS No.:

200-133-6

Place of Origin:

Fujian, China (Mainland)

Packaging & Delivery

Packaging Details:

25kg/drum,or as the requirement

Delivery Detail:

within 10 days after your confirmation (500kg in stock)

Specifications

Spironolactone 
1. CAS No.: 52-01-7 
2. Quality: EP8/USP39 
3. Document: GMP/EDMF/COS(4-AD fermentation process)

4. Specification 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.)	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 EP8/USP39

5. Usage for Spironolactone  

1) As a diuretic, antihypertensive, Spironolactone is used primarily to treat heart failure, axcites in patients with liver disease, low-renin hypertension, hypokalemia

2) As an antiandrogen. Spironolactone is a potent antagonst of the androgen receptor as well as an inhibitor of androgen production.

3) As cosmetic, Spironolactone have an effect in hair grow.

6. Our advantage for Spironolactone with GMP with EDMF, with COS(4-AD fermentation

process):

(1)30 year experience in pharmaceutical industry

(2)ISO9001:2008 certificated company

(3)Fischer Chemicals AG China office