November 22, 2024

Hydrocortisone

Product HYDROCORTISONE BASE
Shelf Life 3 years
ITEM SPECIFICATION RESULT
CHARACTER WHITE TO ALMOST WHITE CRYSTALLINE POWDER ALMOST WHITE CRYSTALLINE POWDER
IDENTIFICATION (A)COMPLIES BY IR CONFORMS
(B)UV:△E/EES≤2.5% 0.2%
TEST
SPECIFIC ROTATION  +150° TO +156° +153.0°
LOSS ON DRYING ≤1.0% 0.3%
RESIDUE ON IGNITION ≤0.5% 0.1%
RELATED SUBSTANCES INDIVIDUAL IMPURITY ≤0.5% 0.28%
TOTAL IMPURITIES ≤2.0% 0.09%
RESIDUAL SOLVENT CYCLOHEXANE ≤3880ppm 2PPM
METHANOL≤3000PPM 82PPM
ASSAY

CONTAINS 97.0% TO 102.0% OF C21H30O5 CALCULATED ON DRIED BASIS 100.1%
CONCLUSION: THE PRODUCT CONFORMS TO USP38 AND CUSTOMER STANDARD.

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