|
S.No. |
TEST |
SPECIFICATION |
|
01. |
Description
|
A white to off white crystalline powder |
| 02. |
Solubility |
Soluble in water ,
Methanol . |
| 03 |
Identification
|
IR: The Infra Red absorption spectrum of the test sample exhibits maxima at the same wavelengths as that of the working standard. |
|
04.
|
Melting Range |
Should be
between 215o C and 220o C |
| 05. |
Loss of Drying |
Not more than 0.5% w/w |
| 06. |
Specification Rotation
(On dried basis) |
Should be between +100 and +14.00 |
| 07. |
Sulphated ash |
Should be lees than 0.2% w/w |
| 08. |
Heavy
Metals |
Should be less than 0.002% w/w |
| 09. |
Chromatographic purity
by HPLC |
Total impurities --- Not more than 1.0%.
|
| 10. |
Assay on dried basis
(By titrimetry) |
Should be between 98.0%
w/w and 102.0%w/w. |
| 11. |
Chiral purity by
HPLC |
Not less than 98.0% ee
|
