Manufacture CAS 113507 06 5 Moxidectin 95% 98%

Item

Specifications

Results

Appearance

White or pale yellow, amorphous powder

Conforms

Identification

IR spectrum corresponds to the IR spectrum of the reference standard

Conforms

Appearance of Solution

The solution is clear and not more intensely colored than reference solution GY5

Conforms

Water

Not more than 1.3%

0.8%

Heavy metals

Not more than 20ppm

Conforms

Sulphated ash

Not more than 0.2%

0.05%

Related substance

Test A Impurity A

Impurity B

Impurity C

Impurity D

Impurity E+F

Impurity G

Any other impurity

Not more than 1.5%

Not more than 0.5%

Not more than 1.5%

Not more than 2.5%

Not more than 1.7%

Not more than 1.5%

Not more than 0.5%

0.9%

0.2%

0.8%

1.2%

0.7%

0.3%

0.1%

Test B Impurity H+I

Impurity J

Impurity K

Any other impurity

Not more than 1.0%

Not more than 0.5%

Not more than 0.5%

Not more than 0.5%

0.1%

0.2%

0.07%

0.1%

Total impurities

Not more than 7.0%

4.8%

Residual solvents

Ethanol

Acetone

Heptance

Dichloromethance

Butyl Acetate

Not more than 5000ppm

Not more than 5000ppm

Not more than 5000ppm

Not more than 600ppm

Not more than 5000ppm

5ppm

Not Detected

45ppm

32ppm

17ppm

Assay(by HPLC)

92.0% to 102.0% (Calculated on anhydrous and solvent free basis)

93.5%

Conclusion

The results conforms with EP 7.0 standards