Cefquinome Sulfate

Appearance

White to light yellow crystalline powder without visible impurities

Identification

HPLC

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.

Reaction of sulphates

White precipitate is formed

Appearance of solution

Clarity

Not stronger than No.1 turbidity standard

Color

Not darker than yellow or yellowish-green standard colorimetric solution No.8

PH (0.1g/ml)

1.6~2.6

Water Content

Not more than 4.0%

Specific optical rotation

16.5~22.5

Heavy metal

NMT 0.0020%

Residue of ignition

Not more than 0.1%

Related substances

Cefotaxime

NMT 0.50%

5,6,7,8-Tetrahydroquinoline

NMT 0.50%

Other individual impurity

NMT 0.20%

Total impurities

NMT 2.0%

Residue solvents

Dichloromethane

NMT 600ppm

Toluene

NMT 890ppm

Ethanol

NMT 5000ppm

Acetone

NMT 5000ppm

Benzene

NMT 2ppm

Assay

Cefquinome sulphate

calculated on anhydrous basis

98.0~101.0%

Cefquinome

82.6~85.1%

Sulphate

15.3~16.3%

Bacterial endotoxin

Less than 0.10EU/mg(Cefquinome)

Sterility

Confirm the test

Particle size

95%≤10μm