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
|