ITEMS
SPECIFICATIONS
RESULTS
CHARACTER
WHITE OR ALMOST WHITE CRYSTALLINE POWDER
ALMOST WHITE CRYSTALLINE POWDER
SPECIFIC ROTATION
+96°~+102°
+98.6°
IDENTIFICATION
A: COMPLIES BY IR
CONFORMS
B: COMPLIES BY TLC
CONFORMS
RELATED SUBSTANCES
INDIVIDUAL IMPURITY IS NOT MORE THAN 1.0%
0.59%
NOT MORE THAN ONE IMPURITY IS GREATER THAN 0.5%
1
TOTAL IMPURITIES NOT MORE THAN 2.0%
0.93%
LOSS ON DRYING
NOT MORE THAN 1.0%
0.10%
ASSAY
IT SHOULD CONTAIN 97.0% TO 103.0% OF C21H28O5 CALCULATED ON DRIED BASIS
98.80%
CONCLUSION
THE RESULTS CAN CONFORMS WITH THE EP7/BP2011