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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