SPIRONOLACTONE 52-01-7

  • FOB Price : USD $100.00 / Piece
  • Minimum order:1
  • Place of Origin:China (Mainland)

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
Conclusion Compiles with EP8/USP38

  • Sinoway Industrial Co., Ltd.
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  • Fax:+86-0592-5854960
  • Email:xie@china-sinoway.com
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Sinoway Industrial Co., Ltd.

Floor 16, Huicheng Business Center, No. 839, Xiahe Rd., Siming Dist. Xiamen, Fujian, China Tel: 5925854962 Country: China (Mainland)