Product name
|
Dexamethasone Acetate
|
Shelf Life
|
3 years
|
Items
|
Standard
|
Results
|
Description
|
White or almost white crystalline powder
|
Almost white crystalline powder
|
Identification
|
IR Complies with the standard
|
Complies
|
UV: no more than 3.0%
|
1.1%
|
Specific Rotation
|
+82° to +88°
|
+86.9°
|
Loss on drying
|
not more than 0.4%
|
0.2%
|
Residue on ignition
|
not more than 0.1%
|
0.06%
|
Chromatographic purity
|
principal impurity no more than 1.0%
|
0.34%
|
total impurities no more than 2.0%
|
0.67%
|
Residual Solvents
|
Acetone no more than 1000ppm
|
86ppm
|
Heavy metal
|
Not more than 20ppm
|
Less than 20ppm
|
Assay
|
97.0% to 102.0% on dried base
|
98.7%
|
Conclusion: The test product complies with the requirements of USP39.
|