Moxidectin

Identification

IR spectrum of sample corresponds to that of reference substance

The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay

Solubility

Hardly soluble in water, easily soluble in ethanol,sightly soluble in hexane

Appearance of solution

The solution should be clear and transparent, and the color in not deep in the control solution of GY5

Water

≤1.3%

Residue on ignition

≤0.5%

Heavy metals

≤20ppm

Assay(anhydrous basis)

92.0%-102.0%

Organic impurities

Early-eluting impurities

Moxidectin butenyl analog (A)                   

≤1.5%

5’-Demethyl moxidectin ( B )                 

≤0.5%

Moxidectin pentenyl analog ( C )              

≤1.5%

Moxidectin 17a-epimer ( D )                     

≤2.5%

Sum of moxidectin 19-S-17a-ene and moxidectin ethyl isomers ( E+F )              

≤1.7%

Milbemycin B analog (moxidectin open ring) ( G )  ≤1.5%

Any other individual impurity eluting before milbemycin B analog (moxidectin open ring)                  ≤0.5%

Late-eluting impurities

Moxidectin deoxydienea and 4’-Methylthiomethoxymoxidectin(H+1)           

≤1.0%

20b-Methylthiomoxidectin( J)                   

≤0.5%

20-Nitrobenzoylmoxidectin (K)                  

≤0.5%

Any other individual impurity eluting after the milbemycin B analog (Moxidectin open ring )             ≤0.5%

Total organic impurities

≤7.0%