Tests  Carried  out

Limits

Characters

A white or almost white, crystalline powder

Specific optical rotation

-153゜~ -170゜

Absorbance

495 ~ 545

Identification

A. B. C. Positive reaction

Acidity or alkalinity

pH 6.0 ~ 8.0

Particulate matter

Meets the requirements

Clarity of solution

Meets the requirements

Color of solution

Not more intensely colored than reference solution Y₇

Related substances

Maximum impurity: 0.5% max  Total impurity: 2.0% max

Water

8.0% ~ 11.0%

Polymer

0.5% max

Heavy metals

20ppm max

Toxicity

Meets the requirements

Bacterial endotoxins

Meets the requirements

Sterility

Meets the requirements

Assay

Contains Ceftriaxone  calculated witty reference to the anhydrous substance, not less than 84.0%