Sinoway Industrial Co., Ltd.

Hidrokortison 50-23-7 Hidrokortison 50-23-7

Hidrokortison 50-23-7
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Informasi dasar Hydrocortisone 50-23-7

  • Nama Produk: Hidrokortison
  • Formula Molekuler: C21H30O5
  • Berat Molekul: 362.46
  • CAS No: 50-23-7
  • Penampilan: Bubuk kristal putih
  • Spesifikasi: EP6 / USP37; EP8

Penggunaan Hidrokortison 50-23-7

  • Rawat untuk dermatitis alergi, eksim, neurodermatitis, dermatitis seboroik, dll.
  • Adrenocortical insufficiency dan hypopituitarism.

COA Hidrokortison 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
Sertifikat Analisis
Nama Produk: Hidrokortison
Batch No: T2930
Manuf. Tanggal: 2014-03-16
Tanggal Pengujian: 2017-03-15
Tanggal Laporan: 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 Hidrokortison 50-23-7

Informasi dasar Hydrocortisone 50-23-7

  • Nama Produk: Hidrokortison
  • Formula Molekuler: C21H30O5
  • Berat Molekul: 362.46
  • CAS No: 50-23-7
  • Penampilan: Bubuk kristal putih
  • Spesifikasi: EP6 / USP37; EP8

Penggunaan Hidrokortison 50-23-7

  • Rawat untuk dermatitis alergi, eksim, neurodermatitis, dermatitis seboroik, dll.
  • Adrenocortical insufficiency dan hypopituitarism.

COA Hidrokortison 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
Sertifikat Analisis
Nama Produk: Hidrokortison
Batch No: T2930
Manuf. Tanggal: 2014-03-16
Tanggal Pengujian: 2017-03-15
Tanggal Laporan: 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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