Dexamethasone base

CAS number: 50-02-2

Molecular formula: C22H29FO5

molecular weight: 392.4611

Chemical structure:

Product
DEXAMETHASONE BASE
Shelf Life
5 years
ITEM
SPECIFICATIONRESULT
CHARACTER
WHITE OR ALMOST WHITE CRYSTALLINE POWDERALMOST WHITE CRYSTALLINE POWDER
SPECIFIC ROTATION +72° TO +80°
+76.2°
IDENTIFICATION(1)COMPLIES BY IRCONFORMS
(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 IGNITIONNOT MORE THAN 0.2%0.07%
RESIDUAL SOLVENT
CHLOROFORM NOT MORE THAN 60ppmNOT DETECTED
METHANOL NOT MORE THAN 1000ppm220ppm
ETHYL ACETATE NOT MORE THAN 300ppm22ppm
ASSAYCONTAINS 97.0% TO 102.0% OF C22H29FO5 CALCULATED ON DRIED BASIS100.1%
CONCLUSIONTHE PRODUCT CONFORMS TO USP39