| Water | 2.8% ~ 4.2% |
| Impurity A | ≤0.024% |
| Conclusion | Up to the EP 10.0 |
| pH | (50mg/15 H2O) 5.0 ~ 7.5 |
| Impurity D | ≤0.2% |
| Solubility | Slightly soluble in water, sparingly soluble in ethanol 96% |
| Assay | Procaine(HPLC): 39%~42%(calculated with reference to the anhydrous substances) |
| Residual Solvents | n-Butanol ≤5000ppm / Ethyl acetate ≤5000ppm |
| Sterility | Meets the requirements |
| Bacterial endotoxins | ≤0.1IU/mg |
| Appearance | white or almost white crystalline powder |
| Any other impurity | ≤0.2% |
| Impurity F | ≤0.5% |
| Impurity E | ≤0.2% |
| Impurity G | ≤0.5% |
| Impurity H | ≤0.5% |
| Impurity I | ≤0.5% |
| Impurity J | ≤0.5% |
| Identifcation | IR spectrum complies with that of the reference standard |
| Impurity B (sum of isomers) | ≤0.4% |
| Impurity C (sum of epimers) | ≤0.4% |
| Specified impurity I | ≤0.2% |
| Total impurity 1 | ≤2.0% |
| Total impurity 2 | ≤2.0% |
| Procaine:benzylpenicillin | 96% ~ 102%(calculated with reference to the anhydrous substances) |
