Sinoway Industrial Co., Ltd.

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

Spironolactone 52-01-7
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Informasi dasar dari Spironolactone 52-01-7

  • Nama Produk: Spironolactone
  • Formula Molekuler: C24H32O4S
  • Berat Molekul: 416,57
  • CAS No: 52-01-7
  • Penampilan: Bubuk putih
  • Spesifikasi: EP8 / USP38

Penggunaan Spironolactone 52-01-7

  • Perlakukan untuk tekanan darah tinggi
  • Obati untuk hiperaldosteronisme primer.
  • Obati untuk Hipokalemia (defisiensi Kalium
  • Gagal jantung yang parah
  • Edema (retensi cairan) dari berbagai kondisi, termasuk edema kongestif; Ascites sirosis hati; edema ginjal
  • Sebagai kosmetik, Spironolactone memiliki efek pada pertumbuhan rambut.

COA dari 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

Informasi dasar dari Spironolactone 52-01-7

  • Nama Produk: Spironolactone
  • Formula Molekuler: C24H32O4S
  • Berat Molekul: 416,57
  • CAS No: 52-01-7
  • Penampilan: Bubuk putih
  • Spesifikasi: EP8 / USP38

Penggunaan Spironolactone 52-01-7

  • Perlakukan untuk tekanan darah tinggi
  • Obati untuk hiperaldosteronisme primer.
  • Obati untuk Hipokalemia (defisiensi Kalium
  • Gagal jantung yang parah
  • Edema (retensi cairan) dari berbagai kondisi, termasuk edema kongestif; Ascites sirosis hati; edema ginjal
  • Sebagai kosmetik, Spironolactone memiliki efek pada pertumbuhan rambut.

COA dari 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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