TEST

SPECIFICATION

RESULT

Character

White or grayish yellow powder,odor free and humidifying

Conform

Identification

1. In the chromatogram of the assay, 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

2. It gives flame reaction of sodium salt

Conform

Water

Not more than 3.0%

0.71%

Acidity(pH)

5.5~7.5

6.2

Color of solution

No more intensity colored than reference solution Yedllow 9 or Orange-yellow 9

Less intensely colored than reference solution Yellow 8

Clarity of solution

No more pronounced than that of reference suspension I

Less pronounced than that of reference suspension I

Assay (Ceftiofur sodium)

No less than 98.0%(anhydrous and aceton free)

98.8%

Related substances

Biggest individual impurity

No more than 0.5%

0.1%

Total

No more than 3.0%

0.98%

Residual solvents

Aceton: no more than 2.0%

1.0%

Particulate matter

≥10μm:no more than 5000 particles/g

597 particles/g

≥25μm:no more than 500 particles/g

27 particles/g

Bacterial endotoxin

No more than 0.2EU/mg (Ceftiofur)

Less than 0.20EU/mg(Ceftiofur)

Sterility

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

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