White to slightly yellow powder,hygroscopic
IR: IR spectrum of the sample corresponds to
that of the mibemycin oxime RS
HPLC:The retention time of the major peaks
of the sample solution corresponds to that of
the standard solution, as obtained in the assay.
11-desmethyl milbemycin A4 oxime: ≤0.7%
Milbemycin D-oxime:≤ 3.0%
Any other individual impurity: ≤ 0.5%
Total impurities: ≤ 5.0%
Sum of milbemycin A4 oxime and milbemycin
95.0%~101.0%(on the anhydrous basis)
The ratio of milbemycin A4 oxime: ≥ 80%
The ratio of milbemycin A3 oxime: ≤ 20%
Conclusion: The Product complies with in-house standard.