| S.no |
Test |
Specification |
| 1.0 |
Appearance |
White or almost white, slightly hygroscopic crystalline powder |
| 2.0 |
Solubility |
Freely soluble in water, soluble in ethanol (96%) |
| 3.0 |
Melting Range |
Between 134°C to 148°C |
| 4.0 |
Identification |
| 4.1 |
Infrared absorption
Spectrometry |
Should match the spectrum with tetracaine Hydrochloride
working standrard. |
| 4.2 |
Melting Range |
melts about 131°C |
| 4.3 |
Chemical Test |
Should develop a Violet Colour |
| 4.4 |
Reaction of Chlorides |
Should comply the test |
| 5.0 |
Appearance of Solution |
Solution should be clear and colourless |
| 6.0 |
pH |
4.5 to 6.5 |
| 7.0 |
Related Substances by HPLC |
| 7.1 |
Impurity –A |
Not more than 0.05% |
| 7.2 |
Impurity- B |
Not more than 0.1% |
| 7.3 |
Impurity –C |
Not more than 0.1% |
| 7.4 |
Unspecified Impurities |
Not more than 0.10% |
| 7.5 |
Total Impurities |
Not more than 0.5% |
| 8.0 |
Heavy Metals |
Not more than 10ppm |
| 9.0 |
Loss on drying |
Not more than 1.0% w/w |
| 10.0 |
Sulphated ash |
Not more than 0.17w/w |
| 11.0 |
Assay by poteniometry
on dried basis |
Between 9.0% w/w to 101.0% w/w |
| 11.1 |
Residual Solvents |
|
| 12.1 |
Methanol |
Not more than 3000 ppm |
| 12.2 |
Hexanes |
Not more than 290 ppm |
| 12.3 |
Toluene |
Not more than 890 ppm |
| 12.4 |
Ethanol |
Not more than 5000 ppm |
| |
|
|
