Test items

Enterprise specification

Test results

Appearance

White to light yellow powder

Off-white powder

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.

Conform

Reaction of sulphates

White precipitate is formed

Conform

Appearance of solution

Clarity

Its opalescence is not more pronounced than that of reference suspension I.

Conform

Color

No more intensely coloured than reference solution Y10 or GY10

Less intensely coloured than reference solution Y7

PH (0.1g/ml)

1.6~2.6

1.7

Water Content

2.5~4.0%

3.0%

Specific optical rotation

+16.5°~+22.5°

+19.5°

Heavy metal

NMT 0.0020%

NMT 0.0020%

Residue of ignition

Not more than 0.3%

0.21%

Related substances

Cefotaxime

NMT 0.50%

0.011%

5,6,7,8-Tetrahydroquinoline

NMT 0.50%

0.06%

Any other

individual impurity

NMT 0.20%

0.17%

Total impurities

NMT 2.0%

0.748%

Residue solvents

Dichloromethane

NMT 0.0600%

Not detected

Toluene

NMT 0.0890%

0.0000252%

Ethanol

NMT 0.5000%

0.001252%

Acetone

NMT 0.5000%

0.02027%

Benzene

NMT 0.0002%

0.00001%

Assay(Cefquinome)

80.0~85.0%

83.2%

Bacterial endotoxin

Less than

0.10EU/mg(Cefquinome)

Conform

Sterility

No growth of micro-organisms should occur after 14 days of incubation

Conform

Particle size

d10:NMT 1.0μm

0.94μm

d50:NMT 4.0μm

2.4μm

d90:NMT 7.0μm

5.6μm