ivermectin
Inspection item standard [2015 edition of the Veterinary Drug Code of the People's Republic of China]
Properties This product is white crystalline powder; Slightly moisture-inducing. This product is soluble in methanol, ethyl acetate or chloroform, dissolved in ethanol or acetone, almost insoluble in water.
To identify
In the chromatogram recorded under the content determination item, the retention time of the main peak of the test solution should be the same as that of the standard solution.
The infrared light absorption spectrum of this product should be consistent with that of the reference product.
Moisture 1.0% or less
Incense burning residue ≤0.1%
Heavy metal 20 PPM or less
Residual solvent ethanol ≤5.0%
Formamide 3.0% or less
The peak area of ivermectin H2B1a should not be less than 90.0% of the sum of the peak areas of ivermectin H2B1a and ivermectin H2B1b.
The content (H2B1A +H2B1b) should be 95.0 ~ 102.0%
The relative retention time of the peak of the related substance ivermectin H2B1A is between 1.3 ~ 1.5 and the sum of each impurity is less than 2.5%
Other single impurities ≤1.0%
Total 5.0% or less