发布日期:2020-09-04 10:05 浏览次数:

| Item | Standard(USP30) | Test Result |
| Appearance | White powder or crystalline powder | White powder |
| Identification | IR | Conform |
| Crystallinity | Meets the requirements | Conform |
| X-ray diffraction | Meets the requirements | Conform |
| Water | ≤3.0% | 1.4% |
| Residue on ignition | ≤1.0% | 0.2% |
| Related Compounds | Erythromycin B ≤3.0% | 1.2% |
| Erythromycin C ≤3.0% | 1.0% | |
| Erythromycin A enol ether ≤3.0% | 1.0% | |
| Erythromycin N-ethylsuccinate ≤3.0% | 1.1% | |
| Any individual related compound ≤3.0% | 0.6% | |
| Residual Solvents | THF: ≤720ppm | 288ppm |
| Assay | ≥76.5% | 77.5% |
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