Cefovecin Sodium 93% GMP factory

Test Items

Test Specifications

Testing Results

Appearance

Should be w hite to   pale yellow  powder

          O ff -w hite   powder

+44 ° to+50 ° (calculated on the anhydrous,acetone-free basis)

+48.2 °

Identification

The retention time of the major peak of sample should correspond to that of reference standard .(HPLC)

C onform

The infrared light absorption spectrum of this product should be consistent with that of the control product

C onform

This product should exhibit the flame reaction of sodium salts.

C onform

pH

5. 5 - 7.5

6.82

Clarity of Solution

Clear or not more opalescent than reference suspension 1.

Clear

Color of Solution 

Not more intense than reference solution Y7 or OY7.

＜ Y2

Water

≤ 2 .0%

0.80%

Related Substances

T he Cefovecin R-isomer should not exceed 0.5 %

0.36 %

T he Cefovecin dimer should not   exceed 0.5 %

0.12 %

Any unknown impurity should not   exceed 0.5 %  

C onform

Total impurities should not exceed 2 .0%

1.37 %

Residual Solvents

Acetone  should not more than 2.5 %

1.20 %



2-Ethylhexanoic acid

≤ 0.5%

C onform

Benzene

≤ 0.0002%

C onform

Heavy metals

≤ 20ppm

C onform

Bacterial endotoxins

＜ 0. 2 0EU/mg

C onform

Assay

Not less than 89.5% c ef ovecin   ( C _{1 9} H _{1 7} N ₅ O ₆ S ₂ ) on the anhydrous ,acetone-free   basis .

93.02 %