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Hydrocortisone Manufacturing Thailand, the United Kingdom and USA
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Hydrocortisone

  • Product Name : Hydrocortisone
  • Grade : IP / BP / USP
  • Therapeutic Category : Anti Inflammatory
  • CAS No : 50-23-7
  • COA : Available
  • MSDS : Available

Description

Hydrocortisone is the pharmaceutical term for cortisol used in oral administration, intravenous injection, or topical application. It is used as an immunosuppressive drug, given by injection in the treatment of severe allergic reactions such as anaphylaxis and angioedema, in place of prednisolone in patients needing steroid treatment but unable to take oral medication, and perioperatively in patients on long-term steroid treatment to prevent Addisonian crisis. It may also be injected into inflamed joints resulting from diseases such as gout.

 

Molecular formula:      C21H30O5

Grade:                             white or almost white crystalline powder

 

Specification:

 

TEST ITEM

SPECIFICATION

RESULTS

Appearance

white or almost white crystalline powder

Confirm

Identification

(A) Complies by IR

(B) Complies by UV≤2.5%

Confirm

1.1%

Specific rotation

+150°~+156°

+153.1°

Loss on drying

≤0.5%

0.1%

Residue on ignition

≤0.5%

0.05%

Related substances

Individual impurity≤0.5%

Total impurities≤2.0%

0.34%

0.58%

Residual Solvents

1,2-DICHLOROETHANE≤5ppm

METHANOL≤3000ppm

ETHANOL≤5000ppm

BUTYL ACETATE≤5000ppm

Undetected

85ppm

Undetected

Undetected

Assay

97.0% -102.0% of C21H30O5

Calculted on dried basis

98.4%

Color

According to the measured value

0.034

Conclusion

Meet the specification according to USP37

 

 Packaging details:

 

Packaging details:

25kg/drum with double plastic bags inside; packed in a cardboard drum or fiber HDPE drum.

Storage:

Stored in a clean, cool, dry area; keep away from moisture and strong, direct light/heat

Shelf Life:

5 years if sealed and store away from direct sun light.

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