BENZOCAINE IP
| Sr No | Tests | Specifications |
|---|---|---|
| 1 | Description | Colourless crystals or a white crystalline powder, odourless. |
| 2 | Solubility | Freely soluble in ethanol (95 percent), in chloroform and in ether; soluble in dilute acids and very slightly soluble in water. |
| 3 | Identification | |
| A. By IR | The IR absorption spectrum of the sample should be concordant with reference spectrum of Benzocaine standard. | |
| 4 | Appearance of Solution | A 5% w/v solution in ethanol (95%) is clear & cololurless. |
| 5 | Acidity or Alkalinity | No pink color is produced with phenolphthalein solution and pink color develop with 0.01M sodium hydroxide solution. |
| 6 | Heavy metals | NMT 10 ppm |
| 7 | Sulphated Ash | NMT 0.1% |
| 8 | Chloride | No turbidity is produced immediately. |
| 9 | Loss on drying | NMT 0.5% |
| 10 | Assay | 99% to 101% (ODB) |
| 11 | Residual Solvents | |
| Ethanol | NMT 5000 ppm | |
| Toluene | NMT 890 ppm |
BENZOCAINE USP
| Sr No | Tests | Specifications |
|---|---|---|
| 1 | Description | Small white crystals or white crystalline powder is odourless is stable in air. |
| 2 | Solubility | Freely soluble in alcohol, in chloroform and in ether, Sparingly soluble in almond oil and in olive oil. Very slightly soluble in water. Dissolve in dilute acid. |
| 3 | Identification | |
| A. By IR | The IR absorption spectrum of the sample should be concordant with reference spectrum of Benzocaine standard. | |
| B. By HPLC | The retention time of the major peak of the sample solution corresponds to that of standard as obtained in the assay. | |
| 4 | Residue on ignition | Not more than 0.1% |
| 5 | Chloride | No turbidity is produced immediately. |
| 6 | Organic Impurities | |
| Amino benzoic acid | NMT 1.0% | |
| Ethyl-4 nitrobenzoate | NMT 1.0% | |
| Any other unspecified impurity | NMT 1.0% | |
| Total Impurity | NMT 1.0% | |
| 7 | Loss on drying | NMT 1.0% |
| 8 | Residual solvents | |
| Ethanol | NMT 5000 ppm | |
| Toluene | NMT 890 ppm | |
| 9 | Assay | 98% to 102% (ODB) |