Short Description:
CAS Number: 64485-93-4
Molecular Formula: C16H17N5NaO7S2
Standard: USP32/BP2010/EP6
Package: 5kg/tin
Description:
CAS Number: 64485-93-4
Molecular Formula: C16H17N5NaO7S2
Standard: USP32/BP2010/EP6
Package: 5kg/tin
| ITEMS | LIMIT |
| Description | An almost white to pale yellow crystalline powder |
| Clarity and color of solution | (1) The solution is clear (2) Absorbance NMT 0.20 |
| Identification | (1) Infrared Absorption (2) The retention time of major peak of Cefotaxime in the Chromatogram of the Assay preparation corresponds to that exhibited in the chromatogram of the standard preparation (3) It responds to the tests for sodium |
| Specific rotation | +58° ~ +64° |
| pH | 4.5 ~ 6.5 |
| Loss on drying | NMT 3.0% |
| Chromatographic purity | |
| Any impurity | NMT 1.0% |
| Total impurities | NMT 3.0% |
| Sterility | Meets the requirements |
| Bacterial endotoxins | <0.20 USP EU/mg Cefotaxime |
| Visible particles | Meet the requirements |
| Methanol | NMT 3000ppm |
| Ethyl Acetate | NMT 5000ppm |
| Assay | 916 – 964ug/mg (Calculated on the dried basis) |
