Sinoway Industrial Co., Ltd.

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

Spironolactone 52-01-7
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Maklumat asas Spironolactone 52-01-7

  • Nama produk: Spironolactone
  • Formula molekul: C24H32O4S
  • Berat molekul: 416.57
  • CAS No .: 52-01-7
  • Rupa: Serbuk putih
  • Spesifikasi: EP8 / USP38

Penggunaan Spironolactone 52-01-7

  • Rawat untuk tekanan darah tinggi
  • Rawat untuk hyperaldosteronisme primer.
  • Rawat untuk Hipokalemia (Kekurangan kalium
  • Kegagalan jantung yang teruk
  • Edema (pengekalan cecair) dari pelbagai keadaan, termasuk edema Congestive; Asma sirosis hati; edema buah pinggang
  • Sebagai kosmetik, Spironolactone mempunyai kesan dalam pertumbuhan rambut.

COA 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

Maklumat asas Spironolactone 52-01-7

  • Nama produk: Spironolactone
  • Formula molekul: C24H32O4S
  • Berat molekul: 416.57
  • CAS No .: 52-01-7
  • Rupa: Serbuk putih
  • Spesifikasi: EP8 / USP38

Penggunaan Spironolactone 52-01-7

  • Rawat untuk tekanan darah tinggi
  • Rawat untuk hyperaldosteronisme primer.
  • Rawat untuk Hipokalemia (Kekurangan kalium
  • Kegagalan jantung yang teruk
  • Edema (pengekalan cecair) dari pelbagai keadaan, termasuk edema Congestive; Asma sirosis hati; edema buah pinggang
  • Sebagai kosmetik, Spironolactone mempunyai kesan dalam pertumbuhan rambut.

COA 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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