| Customization: | Available |
|---|---|
| CAS No.: | 74578-69-1 |
| Formula: | C18h19n8nao7s3 |
|
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| Test items | Standard | Test results |
| Characters | White to yellowish-orange crystalline powder. | Almost white crystalline powder. |
| Identification | A. Spectroscopic identification test, infrared spectroscopy | Complies |
| B. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay. | Complies | |
| C. Identification test -General,Sodium | Positive | |
| Crystallinity | Meets the requirements | Complies |
| pH | 6.0~8.0 | 6.76 |
| Water | 8.0%~11.0% | 9.07% |
| Organic impurities |
- Deacetylcefotaxime lactone ≤0.5% | 0.01% |
| - 7-Aminocephalosporanic acid ≤0.5% | Not detected | |
| - Ceftriaxone triazine analog≤1.0% | 0.07% | |
| - Ceftriaxone benzothiazolyloxime ≤0.2% | Not detected | |
| - Deacyl ceftriaxone ≤0.5% | 0.02% | |
| - Ceftriaxone 3-ene isome ≤0.3% | 0.01% | |
| - Ceftriaxone E-isomer ≤0.5% | Not detected | |
| -Any individual unspecified impurity ≤0.2% | 0.009% | |
| - Total impurities ≤2.5% | 0.14% | |
| Visible foreign matter | ≤5Particles | ≤5Particles |
| Particulate matter | ≥10um,≤6000Particles/g | 114.0 Particles/g |
| ≥25um,≤600Particles/g | 2.0 Particles/g |
| Residual solvents | -Methanol ≤0.3% -Ethanol ≤0.5% -Acetone ≤0.5% -Isopropanol ≤0.5% -Dichloromethane ≤0.06% -Ethyl acetate ≤0.5% -Triethylamine ≤0.02% -Acetonitrile ≤0.041% |
Not detected Not detected 0.01% Not detected Not detected Not detected Not detected Not detected |
| Bacterial endotoxins test | ≤0.20 USP Endotoxin Unit per mg of ceftriaxone. | <0.20EU/mg |
| Sterility | Meets the requirements | Complies |
| Assay |
NLT 795 µg/mg on the anhydrous basis | 929.7µg/mg |
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