| Items | Specifications | Results | |
| Characters | Almost white or yellowish, slightly hygroscopic, crystalline powder | CONFORM | |
| Specific rotation | -155°~ -170° | -161° | |
| Identification |
a. Infrared absorption spectrophotometry; Comparison: ceftriaxone sodium CRS
b. It gives reaction (a) of sodium. |
CONFORM | |
| Clarity of solution | Clear | CONFORM | |
| Color of solution | Not more intensely coloured than reference solution Y5 or BY5 | CONFORM | |
| PH | 6.0-8.0 | 7.3 | |
| Water | 8.0%- 11.0% | 8.9% | |
| Related substances | Any impurity | NMT 1.0% | 0.06% |
| Total impurities | NMT 4.0 % | 0.14% | |
| N, N-Dimethylani line | <0.0020% | NOT DETECTED | |
| 2-ethylhexanoic acid | <0.8% | NOT DETECTED | |
| Sterility | Sterile | CONFORM | |
| Bacterial endotoxins | less than 0.08 lU/mg | CONFORM | |
| Visible particles | Meet the requirement | CONFORM | |
| Sub-visible particles | ≥10μm | ≤2250 particles/g | 296 |
| ≥25μm | ≤225 particles/g | 6 | |
| ASSAY | 96.0% ~ 102.0% of C18H16N8Na2O7S3 (anhydrous substance) | 100.6% | |
| mode of transportation | ||
| By Air | By Express | By Sea |
| suitable for >50 | suitable for sampple order or <50 | suitable for >300 |
| Fast:3-7 days | Fast:3-10 days | Fast: 7-45 days |
| lower than the express cost | high shipping cost | lowest cost |