| Testing Items | Specifications | Results |
| Appearance | White or almost white crystalline powder | Conforms |
| Identification | IR adsorption spectrum of the substance is same as that of Lidocaine HCL CRS | Conforms |
| Appearance of solution | Clear and colorless | Conforms |
| Melting point | 74℃~79℃ | 75℃~76.5℃ |
| PH | 4.0~5.5 | 4.6 |
| Moisture | 5.5~7.0% | 6.44% |
| Sulphated ash | ≤0.10% | 0.02% |
| Impurity A | ≤0.01% | 0.004% |
| Single unspecified impurity | ≤0.10% | 0.02% |
| Total impurity | ≤0.50% | 0.03% |
| Heavy metals | ≤5ppm | ＜5ppm |
| Assay | 99.0~101.0% | 99.8% |
| Conclusion: The Product Conforms to BP/USP. |
||
