| S.no |
Test |
Specification |
Result |
| 1.0 |
Appearance |
White to off white crystalline powder |
White Crystalline powder |
| 2.0 |
Solubility |
Very soluble in water, soluble in alcohol and insoluble in ether and benzene |
Complies |
| 3.0 |
Identification |
| 3.1 |
Ultra Violet
Absorption |
do not difer by more than 2.0 |
Complies |
| 3.2 |
Melting Range |
130°C - 132°C |
130°C – 131.1°C |
| 3.3 |
Chloride |
should be positive |
Complies |
| 4.0 |
Water by KF (w/w) |
NMT 2.0% |
0.46% |
| 5.0 |
Reside on Ignition(w/w) |
NMT 0.1% |
0.04% |
| 6.0 |
Chromatographic Purity
by TLC |
a)Any spot obtained from thetest solution, other thanthe principal spot is not more intense than the principal spot obtained from standard solution (0.4%)
b)Sum of the intensities of any suchspots is not grearer than 0.8% |
Less than 0.4%
Less than 0.8% |
| 7.0 |
Assay by titration on anhydrous basis (w/w) |
NLT 98.5 and NMT 101.0% |
100.3% |
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