Milbemycin Oxime

Item

Specifications

Results

Description

White or light yellow powder

Conforms

Solubility

Practically insoluble, very soluble in acetonitrile, in anhydrous ethanol and in ethyl acetate.

Conforms

Identification

Infrared Identification

Infrared absorption chromatograph obtained with the test solution should be consistent with that of the reference standard solution

Conforms

HPLC Identification

The retention time of the major peaks of the sample solution should correspond to that of the reference standard solution.

Conforms

Residue on Ignition

≤0.5%

0.05%

Water content

≤2.0%

1.4%

Heavy metal

≤30ppm

Conforms

Related Substances

Impurity G

≤2.0%

0.14%

Impurity E

≤0.7%

0.26%

Impurity H

≤0.5%

0.12%

Impurity I

≤0.5%

Negative

Any other impurities

≤0.2%

0.13%

Total impurities

≤3.5%

0.71%

Assay

A3+A4

95.0%~102.0%

98.8%

A3 Ratio

≤0.20

0.17

A4 Ratio

≥0.80

0.83

Residual solvents

Ethanol

≤5000ppm

76ppm

Acetone

≤5000ppm

8ppm

n-Heptane

≤5000ppm

1ppm

Methanol

≤3000ppm

28ppm

4-Dioxane

≤380ppm

Negative

Methylene chloride

≤600ppm

Negative

Chloroform

≤60ppm

Negative

Conclusion

The results conforms with enterprise standards