Sinoway Industrial Co., Ltd.

Hydrocortisone Acetate 50-03-1 Hydrocortisone Acetate 50-03-1

Hydrocortisone Acetate 50-03-1
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Basic information of Hydrocortisone Acetate 50-03-1

  • Product Name: Hydrocortisone Acetate
  • Molecular Formula: C23H32O6
  • Molecular Weight: 404.5
  • CAS No.: 50-03-3
  • Appearance: White crystalline powder
  • Specifications: EP8; EP6/USP37

Usage of Hydrocortisone Acetate 50-03-1

  • Eczema, itchy skin, neurodermatitis, seborrheic dermatitis,  allergic dermatitis, pruritus
  • Allergic conjunctivitis

COA of Hydrocortisone Acetate 50-03-1-1

Items

Standards

Results

Characters

A white or almost white, crystalline powder

White crystalline powder

Solubility(annual)

Practically insoluble in water, slightly soluble in anhydrous ethanol and in methylene chloride

Complies

Identification

A. IR-spectrum

B. HPLC


Meets the requirement

Meets the requirement


Complies

Complies

Specific optical rotation

Between +158°And +167°

+164.3°

Loss on drying

Not more than 0.5%

0.12%

Related substances



Impurity A RRT0.4

Not more than 0.4%

0.07%

Impurity B RRT0.7

Not more than 0.3%

N. D

Impurity C RRT0.9

Not more than 0.6%

0.08%

Impurity D RRT1.2

Not more than 0.3%

0.05%

Impurity G RRT1.8

Not more than 0.15%

N. D

Impurity E RRT2.3

Not more than 0.3%

N. D

Any unspecified impurity

Not more than 0.10%

Complies

Total

Not more than 1.0%

0.39%

Residual solvent( in-house )

Ethanol

DMF


Not more than 2000ppm

Not more than 880ppm


405ppm

Not detect out


Assay

Between 97.0% and 103.0%

99.1%

Particle size(In-house )

90% not more than 20 microns

Complies

Conclusion

The product conforms to Ph.Eur.8

COA of Hydrocortisone Acetate 50-03-1-2

Items

Standards

Results

Characters

A white or almost white, crystalline powder

White crystalline powder

Solubility(annual)

Soluble in anhydrous ethanol and in methylene chloride

Complies

Melting point(Ph.Eur)

About 220℃

220℃

Identification

A. IR-spectrum(Ph.Eur)

B. TLC(Ph.Eur.)

A.IR-spectrum(USP)

B.TLC(USP)


Meets the requirement

Meets the requirement

Meets the requirement

Meets the requirement


Complies

Complies

Complies

Complies

Specific Rotation

Ph.Eur

Between +158°and +167°

+163.7°

USP

Between+158°and +165°

+164.0°

Loss on drying

(Ph.Eur.)

(USP)


Not more than 0.5%

Not more than 1.0%


0.11%

0.03%

Residue on ignition(USP)

Not more than 0.5%

0.35%

Related substances(Ph.Eur)

Any individual impurity



Sum of impurities


Not more than 1.0%

Not more than one such peak has an area greater than 0.5%

Not more than 1.5%


0.32%

Complies


0.78%

Chromatographic purity(USP)

Any individual impurity

Sum of impurities


Not more than 1.0%

Not more than 2.0%


0.35%

0.88%

Residual solvent( in-house )

Methanol

Chloroform

Pyridine

DMF


Not more than 500ppm

Not more than 60ppm

Not more than 200ppm

Not more than 880ppm


Not detect out

Not detect out

Not detect out

703ppm

Assay

Ph.Eur.

USP


Between 97.0% and 103.0%

Between 97.0% and 102.0%



100.9%

97.6%

Particle size

90% not more than 20 microns

Complies

Conclusion

The product conforms to Ph.Eur.6/USP37


MORE_DETAIL Hydrocortisone Acetate 50-03-1

Basic information of Hydrocortisone Acetate 50-03-1

  • Product Name: Hydrocortisone Acetate
  • Molecular Formula: C23H32O6
  • Molecular Weight: 404.5
  • CAS No.: 50-03-3
  • Appearance: White crystalline powder
  • Specifications: EP8; EP6/USP37

Usage of Hydrocortisone Acetate 50-03-1

  • Eczema, itchy skin, neurodermatitis, seborrheic dermatitis,  allergic dermatitis, pruritus
  • Allergic conjunctivitis

COA of Hydrocortisone Acetate 50-03-1-1

Items

Standards

Results

Characters

A white or almost white, crystalline powder

White crystalline powder

Solubility(annual)

Practically insoluble in water, slightly soluble in anhydrous ethanol and in methylene chloride

Complies

Identification

A. IR-spectrum

B. HPLC


Meets the requirement

Meets the requirement


Complies

Complies

Specific optical rotation

Between +158°And +167°

+164.3°

Loss on drying

Not more than 0.5%

0.12%

Related substances



Impurity A RRT0.4

Not more than 0.4%

0.07%

Impurity B RRT0.7

Not more than 0.3%

N. D

Impurity C RRT0.9

Not more than 0.6%

0.08%

Impurity D RRT1.2

Not more than 0.3%

0.05%

Impurity G RRT1.8

Not more than 0.15%

N. D

Impurity E RRT2.3

Not more than 0.3%

N. D

Any unspecified impurity

Not more than 0.10%

Complies

Total

Not more than 1.0%

0.39%

Residual solvent( in-house )

Ethanol

DMF


Not more than 2000ppm

Not more than 880ppm


405ppm

Not detect out


Assay

Between 97.0% and 103.0%

99.1%

Particle size(In-house )

90% not more than 20 microns

Complies

Conclusion

The product conforms to Ph.Eur.8

COA of Hydrocortisone Acetate 50-03-1-2

Items

Standards

Results

Characters

A white or almost white, crystalline powder

White crystalline powder

Solubility(annual)

Soluble in anhydrous ethanol and in methylene chloride

Complies

Melting point(Ph.Eur)

About 220℃

220℃

Identification

A. IR-spectrum(Ph.Eur)

B. TLC(Ph.Eur.)

A.IR-spectrum(USP)

B.TLC(USP)


Meets the requirement

Meets the requirement

Meets the requirement

Meets the requirement


Complies

Complies

Complies

Complies

Specific Rotation

Ph.Eur

Between +158°and +167°

+163.7°

USP

Between+158°and +165°

+164.0°

Loss on drying

(Ph.Eur.)

(USP)


Not more than 0.5%

Not more than 1.0%


0.11%

0.03%

Residue on ignition(USP)

Not more than 0.5%

0.35%

Related substances(Ph.Eur)

Any individual impurity



Sum of impurities


Not more than 1.0%

Not more than one such peak has an area greater than 0.5%

Not more than 1.5%


0.32%

Complies


0.78%

Chromatographic purity(USP)

Any individual impurity

Sum of impurities


Not more than 1.0%

Not more than 2.0%


0.35%

0.88%

Residual solvent( in-house )

Methanol

Chloroform

Pyridine

DMF


Not more than 500ppm

Not more than 60ppm

Not more than 200ppm

Not more than 880ppm


Not detect out

Not detect out

Not detect out

703ppm

Assay

Ph.Eur.

USP


Between 97.0% and 103.0%

Between 97.0% and 102.0%



100.9%

97.6%

Particle size

90% not more than 20 microns

Complies

Conclusion

The product conforms to Ph.Eur.6/USP37

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