Product
|
HYDROCORTISONE BASE
|
Shelf Life
|
3 years
|
ITEM
|
SPECIFICATION
|
RESULT
|
CHARACTER
|
WHITE TO ALMOST WHITE CRYSTALLINE POWDER
|
ALMOST WHITE CRYSTALLINE POWDER
|
IDENTIFICATION
|
(A)COMPLIES BY IR
|
CONFORMS
|
(B)UV:△E/EES≤2.5%
|
0.2%
|
TEST
|
SPECIFIC ROTATION
|
+150° TO +156°
|
+153.0°
|
LOSS ON DRYING
|
≤1.0%
|
0.3%
|
RESIDUE ON IGNITION
|
≤0.5%
|
0.1%
|
RELATED SUBSTANCES
|
INDIVIDUAL IMPURITY ≤0.5%
|
0.28%
|
TOTAL IMPURITIES ≤2.0%
|
0.09%
|
RESIDUAL SOLVENT
|
CYCLOHEXANE ≤3880ppm
|
2PPM
|
METHANOL≤3000PPM
|
82PPM
|
ASSAY
|
CONTAINS 97.0% TO 102.0% OF C21H30O5 CALCULATED ON DRIED BASIS
|
100.1%
|
CONCLUSION:
|
THE PRODUCT CONFORMS TO USP38 AND CUSTOMER STANDARD.
|