| 03 |
Melting Range
|
The two temperatures should fall
between 122o C and 126o C
|
|
04.
|
Loss
of Drying |
Not more than
0.50% w/w |
|
05.
|
Specific rotation
on dried basis |
Should be between
-30o and -34o |
|
06.
|
Assay on dried basis by
HPLC |
Should be between 98.0% w/w and 102.0% w/w |
|
07.
|
Related substances
By GC |
Maximum single impurity -Not more than 1.0%.
Total impurities-Not more than 2.0% |
|
08.
|
Residual Solvents by GC |
Methanol -- Not more than 1000ppm
Tolune -- Not more than 1000 ppm
|
