Item | Specification |
Appearance | White or off-white powder |
Identification | Infrared spectroscopy |
The retention times of the major peaks of the Sample solution correspond to those of the Standard solution, as obtained in the Assay. | |
Residue on ignition | ≤0.5% |
Organic impurities | 11’-Desmethylmibemycin A4 oxime ≤0.7% |
(20’R)-Hydroxymilbemycin A4 keto form ≤0.5% | |
Milbemycin A4 keto form ≤0.7% | |
Milbemycin D-oxime ≤3.0% | |
Any other individual impurity ≤0.5% | |
Total impurities ≤3.5% | |
Water determination | ≤3.0% |
Residual solvents | Ethanol ≤5000ppm |
N-Heptane ≤5000ppm | |
Acetone ≤5000ppm | |
Dichloromethane ≤600ppm | |
Chloroform ≤60ppm | |
Microbial limit | Total aerobic bacteria ≤500cfu/g |
Total combined yeasts and molds ≤100cfu/g | |
Escherichia coli Absent/g | |
Assay | Milbemycin Oxime (A3+A4): 95.0%~101.0%, calculated on the anhydrous basis |
Ratio A4 / (A3+A4) ≥0.80 | |
Ratio A3 / (A3+A4) ≤0.20% |