Sinoway Industrial Co., Ltd.

Hidrocortisona 50-23-7 Hidrocortisona 50-23-7

Hidrocortisona 50-23-7
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Informação básica de Hydrocortisone 50-23-7

  • Nome do produto: hidrocortisona
  • Fórmula Molecular: C21H30O5
  • Peso Molecular: 362.46
  • Nº CAS: 50-23-7
  • Aparência: branco pó cristalino
  • Especificações: EP6 / USP37; EP8

Uso de hidrocortisona 50-23-7

  • Trate por dermatite alérgica, eczema, neurodermatite, dermatite seborréica, etc.
  • Insuficiência adrenocortical e hipopituitarismo.

COA de hidrocortisona 50-23-7

SINOWAY INDUSTRIAL CO., LTD.
16 / F., HUICHENG COMM.COMPLEX, 839 XIAHE RD., XIAMEN, CHINA
TEL: 0086-592-5854962 POSTCODE: 361004
FAX: 0086-592-5854960 E-MAIL: sale3@china-sinoway.com
Certificado de análise
Nome do produto: hidrocortisona
Lote nº .: T2930
Manuf. Data: 2014-03-16
Data do novo teste: 2017-03-15
Data do relatório: 2014-04-09

Items

Specifications

Results

Appearance

A white or almost white,crystalline powder

Whitecrystalline powder

Solubility

Practically insoluble in water, sparingly soluble in acetone and in alcohol, slightly in methylene chloride

Complies

Identification



A: IR-Spectrum

Meets the requirement

Complies

B: HPLC

Meets the requirement

Complies

Specific optical rotation

Between+162°and +168°

+165.4°

Loss on drying

Not more than 1.0%

0.09%

Related substances



Impurity D RRT0.2

Not more than 0.50%

0.23%

Impurity H RRT0.3

Not more than 0.15%

N.D

Impurity I RRT0.5

Not more than 0.50%

0.17%

Impurity M RRT0.7

Not more than 0.10%

0.09%

Impurity G RRT0.8

Not more than 0.40%

0.08%

Impurity E RRT0.86

Not more than 0.50%

0.09%

Impurity A RRT0.96

Not more than 0.20%

0.09%

Impurity B RRT1.1

Not more than 0.20%

N. D

Impurity F RRT1.4

Not more than 0.30%

0.06%

Impurity C RRT1.5

Not more than 0.50%

0.08%

Impurity N RRT1.7

Not more than 0.15%

N.D

Any unspecified impurity

Not more than 0.10%

Complies

Sum of impurities

Not more than 2.0%

1.01%

Assay

Between 97.0% and 103.0%

100.7%

Residual solvents (in-house)



Methanol

Not morethan 500ppm

Not detect out

Ethanol

Not more than 2000ppm

Not detect out

Methylene chloride

Not more than 600ppm

Not detect out

Chloroform

Not more than 60ppm

Not detect out

Particle size (In-house )

90% not more than 15micron

Complies

Conclusion

The product conforms to Ph.Eur. 8.0



MORE_DETAIL Hidrocortisona 50-23-7

Informação básica de Hydrocortisone 50-23-7

  • Nome do produto: hidrocortisona
  • Fórmula Molecular: C21H30O5
  • Peso Molecular: 362.46
  • Nº CAS: 50-23-7
  • Aparência: branco pó cristalino
  • Especificações: EP6 / USP37; EP8

Uso de hidrocortisona 50-23-7

  • Trate por dermatite alérgica, eczema, neurodermatite, dermatite seborréica, etc.
  • Insuficiência adrenocortical e hipopituitarismo.

COA de hidrocortisona 50-23-7

SINOWAY INDUSTRIAL CO., LTD.
16 / F., HUICHENG COMM.COMPLEX, 839 XIAHE RD., XIAMEN, CHINA
TEL: 0086-592-5854962 POSTCODE: 361004
FAX: 0086-592-5854960 E-MAIL: sale3@china-sinoway.com
Certificado de análise
Nome do produto: hidrocortisona
Lote nº .: T2930
Manuf. Data: 2014-03-16
Data do novo teste: 2017-03-15
Data do relatório: 2014-04-09

Items

Specifications

Results

Appearance

A white or almost white,crystalline powder

Whitecrystalline powder

Solubility

Practically insoluble in water, sparingly soluble in acetone and in alcohol, slightly in methylene chloride

Complies

Identification



A: IR-Spectrum

Meets the requirement

Complies

B: HPLC

Meets the requirement

Complies

Specific optical rotation

Between+162°and +168°

+165.4°

Loss on drying

Not more than 1.0%

0.09%

Related substances



Impurity D RRT0.2

Not more than 0.50%

0.23%

Impurity H RRT0.3

Not more than 0.15%

N.D

Impurity I RRT0.5

Not more than 0.50%

0.17%

Impurity M RRT0.7

Not more than 0.10%

0.09%

Impurity G RRT0.8

Not more than 0.40%

0.08%

Impurity E RRT0.86

Not more than 0.50%

0.09%

Impurity A RRT0.96

Not more than 0.20%

0.09%

Impurity B RRT1.1

Not more than 0.20%

N. D

Impurity F RRT1.4

Not more than 0.30%

0.06%

Impurity C RRT1.5

Not more than 0.50%

0.08%

Impurity N RRT1.7

Not more than 0.15%

N.D

Any unspecified impurity

Not more than 0.10%

Complies

Sum of impurities

Not more than 2.0%

1.01%

Assay

Between 97.0% and 103.0%

100.7%

Residual solvents (in-house)



Methanol

Not morethan 500ppm

Not detect out

Ethanol

Not more than 2000ppm

Not detect out

Methylene chloride

Not more than 600ppm

Not detect out

Chloroform

Not more than 60ppm

Not detect out

Particle size (In-house )

90% not more than 15micron

Complies

Conclusion

The product conforms to Ph.Eur. 8.0


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