Item | Specification |
Appearance | White or pale yellow amorphous powder |
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 | |
Water | ≤1.3% |
Residue on ignition | ≤0.2% |
Heavy metals | ≤20ppm |
Assay | 92.0-102.0% (anhydrous Substance) |
Organic Impurities | |
Early-eluting impurities | Moxidectin butenyl analog ≤1.5% |
5’-Demethyl Moxidectin ≤0.5% | |
Moxidectin Pentenyl Analog ≤1.5% | |
Moxidectin 17a-epimer ≤2.5% | |
Sum of moxidectin 19-s-17a-ene and moxidectin ethyl isomers (E+F) ≤1.7% | |
Mibemycin B analog (moxidectin open ring) ≤1.5% | |
Any other individual impurity eluting before milbemycin B analog (moxidectin open ring) ≤0.5% | |
Late Elutomg impurities | Moxidectin deoxydienea, and 4’-Methylthiomethoxymoxidectin (H+I) ≤ 1.0% |
20b-Methylthiomoxidctin (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% |
Solvent residue | Methanol ≤ 3000ppm Methylene Chloride ≤ 300ppm Isopropyl Acetate ≤ 5000ppm N-Heptane ≤ 5000ppm |
BHT | 0.3%-0.6% |