November 21, 2024

Dexamethasone base

Product DEXAMETHASONE BASE
Shelf Life 5 years
ITEM SPECIFICATION RESULT
CHARACTER WHITE OR ALMOST WHITE CRYSTALLINE POWDER ALMOST WHITE CRYSTALLINE POWDER
SPECIFIC ROTATION  +72° TO +80° +76.2°
IDENTIFICATION (1)COMPLIES BY IR CONFORMS
(2)UV:△E/ERS ≤3.0% 1.8%
TEST
CHROMATOGRAPHIC PURITY PRINCIPAL IMPURITY NOT MORE THAN 1.0% 0.13%
TOTAL IMPURITIES NOT MORE THAN 2.0% 0.43%
LOSS ON DRYING NOT MORE THAN 0.5% 0.09%
RESIDUE ON IGNITION NOT MORE THAN 0.2% 0.07%
RESIDUAL SOLVENT CHLOROFORM NOT MORE THAN 60ppm NOT DETECTED
METHANOL NOT MORE THAN 1000ppm 220ppm
ETHYL ACETATE NOT MORE THAN 300ppm 22ppm
ASSAY CONTAINS 97.0% TO 102.0% OF C22H29FO5 CALCULATED ON DRIED BASIS 100.1%
CONCLUSION THE PRODUCT CONFORMS TO USP39

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