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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. |
