ITEMS

SPECIFICATIONS

RESULTS

Appearance

White to Off-white Crystalline powder

Conform

Identification

The retention time of the principal peak

in the chromatogram obtained with the

test solution correspoonds to that of the

principal peak in the chromatogram

obtained with reference solution.

Conform

Reaction of  Chloride

Conform

Appearance of solution

Clarity

Not stronger than No.1 Turbidity Standard

<1

Color

Not darker than standard solution Y9

<8

Solubility

Soluble in N, N- Dimethylacetamide, slightly

soluble in 5% of sodium bicarbonate and methanol.

Conform

PH

2.0~3.0

2.2

Water Content

1.5%~4.0%

1.6%

Specific optical Rotation

-115°~-127°

-117°

Heavy metal

NMT 0.0020%

Conform

Residue of ignition

NMT 0.20%

0.15%

Related substances

The biggest impurity

NMT 0.20%

0.09

Total impurities

NMT 1.50%

0.38

Residue solvents

Ethyl Acetate

NMT 0.5000%

0

THF

NMT 0.0720%

0.006

Acetone

NMT 0.5000%

0.2739%

Benzene

NMT 0.0002%

0.0001

Assay

Ceftiofur Hydrochloride

NLT 98.0%

100.4%

Chloride

6.0%~6.5%

6.2%

Bacterial Endotoxin

Less than 0.20EU/mg

Conform

Sterility

Conforms the test

Conform

Particle size

D (0,1)

1.8

D (0,5)

<4

1.4

D (0,9)

<1

<7

3.7

D (1,0)

<10

4.2

CONCLUSION

THE TEST RESULTS CONFORMS

TO THE SPECIFICATION