Ceftiofur Hydrochloride(103980-44-5)
Product Description
Ceftiofur is an antibiotic of the cephalosporin type (third generation), licensed for use in veterinary medicine. It was first described in 1987.
It is resistant to the antibiotic resistance enzyme beta-lactamase, and has activity against both Gram-positive and Gram-negative bacteria. E. coli strains resistant to ceftiofur have been reported.
Ceftiofur Hydrochloride is the hydrochloride salt form of ceftiofur, a semisynthetic, beta-lactamase-stable, broad-spectrum, third-generation cephalosporin with antibacterial activity. Ceftiofur binds to and inactivates penicillin-binding proteins (PBPs) located on the inner membrane of the bacterial cell wall. PBPs are enzymes involved in the terminal stages of assembling the bacterial cell wall and in reshaping the cell wall during growth and division. Inactivation of PBPs interferes with the cross-linkage of peptidoglycan chains necessary for bacterial cell wall strength and rigidity. This results in the weakening of the bacterial cell wall and causes cell lysis.
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ITEMS |
SPECIFICATIONS |
RESULTS |
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Appearance |
White to Off-white Crystalline powder |
Conform |
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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 |
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Reaction of Chloride |
Conform |
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Appearance of solution |
Clarity |
Not stronger than No.1 Turbidity Standard |
<1 |
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Color |
Not darker than standard solution Y9 |
<8 |
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Solubility |
Soluble in N, N- Dimethylacetamide, slightly soluble in 5% of sodium bicarbonate and methanol. |
Conform |
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PH |
2.0~3.0 |
2.2 |
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Water Content |
1.5%~4.0% |
1.6% |
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Specific optical Rotation |
-115°~-127° |
-117° |
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Heavy metal |
NMT 0.0020% |
Conform |
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Residue of ignition |
NMT 0.20% |
0.15% |
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Related substances |
The biggest impurity |
NMT 0.20% |
0.09 |
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Total impurities |
NMT 1.50% |
0.38 |
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Residue solvents |
Ethyl Acetate |
NMT 0.5000% |
0 |
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THF |
NMT 0.0720% |
0.006 |
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Acetone |
NMT 0.5000% |
0.2739% |
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Benzene |
NMT 0.0002% |
0.0001 |
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Assay |
Ceftiofur Hydrochloride |
NLT 98.0% |
100.4% |
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Chloride |
6.0%~6.5% |
6.2% |
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Bacterial Endotoxin |
Less than 0.20EU/mg |
Conform |
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Sterility |
Conforms the test |
Conform |
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Particle size |
D (0,1) |
<1 |
1.8 |
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D (0,5) |
<4 |
1.4 |
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D (0,9) |
<7 |
3.7 |
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D (1,0) |
<10 |
4.2 |
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CONCLUSION |
THE TEST RESULTS CONFORMS TO THE SPECIFICATION |
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