|
S.No. |
TEST |
SPECIFICATION |
|
01. |
Description
|
A white crystalline
powder. |
| 02. |
Solubility |
Slightly soluble in methanol. |
| 03 |
Identification
|
a) IR: The Infra Red absorption spectrum of the finely ground sample in KBr
dispersion compressed into a disc should exhibit maxima only at the same wavelengths as that of a similar preparation of working standard. |
|
04.
|
Melting Range |
Should be between
228o C and 232o C |
| 05. |
Optical Rotation |
Should be between +3.00 and +4.50
|
| 06. |
Loss of Drying |
Not more than 0.5% w/w |
| 07. |
Sulphated ash |
Should not be more than
0.2% w/w |
| 08. |
Heavy Metals |
Not more than 0.002 % w/w |
| 09. |
Chromatographic purity
By HPLC |
Maximum
Single Impurity - NMT : 0.5%
Total Impurities - NMT : 1.0% |
| 10. |
Assay by titration
(on dried basis) |
Should be between 98.0% and 102.0% w/w
|
