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Spironolactone 52-01-7 Spironolactone 52-01-7

Spironolactone 52-01-7
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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


MORE_DETAIL Spironolactone 52-01-7

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

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