Dexamethasone base

CAS number:50-02-2

Molecular formula:C22H29FO5

molecular weight:392.4611

Chemical structure:

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