| S.no |
Test |
Specification |
Result |
| 1.0 |
Appearance |
White or almost white, slightly hygroscopic crystalline powder |
White,slightly
hygroscopic crystalline powder |
| 2.0 |
Solubility |
Freely soluble in water,
soluble in ethanol (96%) |
Complies |
| 3.0 |
Identification |
| 3.1 |
By IR |
IR Spectrum of the test sample should match with standard Spectrum of Tetracaine Hydrochloride Standrard |
Complies |
| 3.2 |
Melting Range |
melts about 131°C |
131.8°C – 132.9°C |
| 3.3 |
Chemical Test |
Should develop a Violet
Colour |
Complies |
| 3.4 |
Reaction of Chlorides |
Should comply the test |
Complies |
| 4.0 |
Appearance of Solution |
Solution should be clear and colourless |
Clear and Colourless |
| 5.0 |
pH |
4.5 to 6.5 |
5.4 |
| 6.0 |
Related Substances by HPLC (in%) |
| 6.1 |
Impurity - A |
NMT 0.05% |
Not detected |
| 6.2 |
Impurity - B |
NMT 0.1% |
0.01 |
| 6.3 |
Unspecified Impurities |
NMT 0.10% |
0.06 |
6.4
|
Total Impurities |
NMT 0.5% |
0.3 |
| 7.0 |
Heavy Metals |
NMT 10ppm |
Less than 10 |
| 8.0 |
Loss on drying |
NMT 1.0% w/w |
0.22 |
| 9.0 |
Sulphated ash |
NMT0.1w/w |
0.04 |
| 10.0 |
Assay by Titration
on dried basis
(% w/w) |
Between 99.0% w/w to 101.0 |
99.8 |
| |
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