Tulathromycin

Appearance

White or almost white crystalline powder

Identification

HPLC:The retention time of the major peak corresponds to that of the reference substance solution, as obtained in the Assay

IR spectrum of the sample corresponds to that of reference

Solubility

Freely soluble in methanol, acetone, ethyl acetate, Soluble in ethanol

Water

≤0.5%

Residual solvents

Methylene chloride

≤600 ppm

Ethyl acetate

≤5000 ppm

Heptane

≤5000 ppm

Specific rotation

-22°~ -26°

Residue on ignition

≤0.2%

Heavy Metals

≤20 ppm

Assay

Tulathromycin A should be at 96.0%-102.0% ( on dried substance)

Related substances

Tulathromycin B

≤1.0%

Impurity C

≤0.5%

Impurity D

≤0.5%

Impurity E

≤0.5%

Any single impurity

≤0.2%

Total impurities

≤3.0%