Appearance

White or off-white powder

Identification

1)The IR absorption spectrum of the substance to be examined corresponds to that of the reference standard.

2)The retention time of the principal peak in the chromatogram obtained with the test solution corresponds to that of the principal peak in the chromatogram obtained with reference solution,as obtained in the assay.

Specific rotation

(anhydrous and solvent-free)

-22°~ -26°

Water

≤0.5%

Demethyl-azithromycin

≤0.5%

Structural isomer of tulathromycin

≤0.50%

Enantiomer of tulathromycin

≤0.50%

Impurity 1

≤0.20%

Impurity 2

≤0.20%

Impurity 3

≤0.20%

Impurity 4

≤0.20%

Any individual unknown impurity

≤0.20%

Total impurity

≤6.0%

Residue on ignition

≤0.1%

Heavy metal

≤0.0020%

Bacterial endotoxin

(Tulathromycin)

＜2EU/mg

Bacterial count

≤1000cfu/g

Yeasts and mould count

≤100cfu/g

Escherichia coli

Not detectable

Methanol

≤0.30%

Ethanol

≤0.50%

Acetone

≤0.50%

Methylene dichloride

≤0.06%

Isopropanol

≤0.50%

Tetrahydrofuran

≤0.072%

N-heptane

≤0.50%

Dimethyl sulfoxide

≤0.50%

Triethylamine

≤0.032%

N-propylamin

≤0.025%

Residue of palladium

≤0.0001%

Sulfate

Assay(anhydrous and solvent-free)

Study(≤0.02%）

Sum of tulathromycin and structural isomer of tulathromycin:95.0%~103.0%