| Product Name: | Cefuroxime sodium sterile | |
| Shelf Life | 2 years | |
| Parameter | Specification | Results |
| Characters | ||
| Appearance | White or almost white, slightly hygroscopic powder. | Compiles |
| Solubility | Freely soluble in water, very slightly soluble in ethanol (96 per cent) | Complies |
| Identification | ||
| Cefuroxime sodium | IR-spectra of the substance to be examined and of cefuroxime sodium CRS show comparable wave numbers and intensities of signals. | Positive |
| Sodium | It gives the reaction (a) of sodium. | Positive |
| Tests | ||
| Appearance of solution | Not more opalescent than reference [[. | Complies |
| Absorbance of solution | Not more than 0.25 (at 450 nm) | 0.04 |
| pH | 5.5-8.5 | 6.8 |
| Specific optical rotation | +59Q〜+66Q (Anhydrous substance) | +61° |
| Water | Not more than 3,5% | 2.1% |
| Sterility | Meets the requirement | Complies |
| Bacterial endotoxin | <0.10IU/mg | Complies |
| Sub-visible particles | >10pm: n.m.t, 600 per gram | 139 |
| >25pm; n.m.t. 60 per gram | 23 | |
| Visible particles | Shall not be detected | / |