104010-37-9

Test items

Enterprise specification

Test results

Conclusion

Character

White to grayish yellow powder, odor free and humidifying

Light 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.

Conform

Conform

2. It gives flame reaction of sodium salt.

Conform

Water

No more than 3.0%

0.4%

Conform

Acidity (pH)

5.5~7.5

6.5

Conform

Color of solution

No more intensely colored than reference solution Yellow 9 or Orange-Yellow 9

Less intensely colored than reference solution Y7

Conform

Clarity of solution

No more pronounced than that of reference suspension I

Less pronounced than that of reference suspension I

Conform

Assay (anhydrous)

C₁₉H₁₇N₅O₇S₃: no less than 85.0%

89.4%

Conform

Related substances

Biggest individual impurity

No more than 0.5%

0.11%

Total

No more than 3.0%

0.99%

Residual solvents

Acetone: no more than 2.0%

1.0%

Conform

Particulate matter

≥10µm: no more than 5000 particles/g

537

Conform

≥25µm: no more than 500 particles/g

4

Conform

Bacterial endotoxin

No more than 0.2EU/mg (Ceftiofur)

Conform

Conform

Sterility

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

Conform

Conform