WHERE THE LABEL INDICATES THAT THERE ARE NO ADDED SUBSTANCES —

WHERE THE LABEL INDICATES THAT THERE ARE ADDED SUBSTANCES —

Procedure— Perform the Assay on individual containers using Assay preparation 2, Assay preparation 3, or Assay preparation 4, as appropriate.

100ri / (ris + rc),

(Official January 1, 2007)

0.05 M Phosphate buffer, Solution A, Solution B, Mobile phase, Standard preparation, Resolution solution, and Chromatographic system— Prepare as directed in the Assay under Cefotaxime Sodium.

Assay preparation 1 (for use where the Weight Variation test is to be performed)—Transfer about 40 mg of Cefotaxime for Injection, accurately weighed, to a 50-mL volumetric flask, add about 40 mL of Solution A, swirl to dissolve, dilute with Solution A to volume, and mix. [NOTE—Use this solution promptly. It may be used within 24 hours if stored in the refrigerator.]

Assay preparation 2 (for use in assaying vials and infusion bottles packaged for dispensing)—Constitute 1 container of Cefotaxime for Injection with the smallest volume of diluent specified in the labeling. Invert the container, and withdraw all of the withdrawable contents of the container with a hypodermic needle and syringe. Transfer the contents of the syringe to a 100-mL volumetric flask, dilute with Solution A to volume, and mix. [NOTE—Do not rinse the syringe or container.] Dilute an accurately measured volume of this solution quantitatively with Solution A to obtain a solution having a concentration of about 0.8 mg of cefotaxime (C16H17N5O7S2) per mL. [NOTE—Use this solution promptly. It may be used within 24 hours if stored in the refrigerator.]

Assay preparation 3 (for use in assaying piggyback infusion bottles)—Constitute 1 container of Cefotaxime for Injection with the smallest volume of diluent recommended in the labeling, using the directions specified in the labeling. Proceed as directed for Assay preparation beginning with “Invert the container. . . .”

Assay preparation 4 (for use in assaying pharmacy bulk packages where the label states the quantity of cefotaxime in a given volume of constituted solution)—Constitute 1 container of Cefotaxime for Injection with the volume of diluent, accurately measured, specified in the labeling. With a hypodermic needle and syringe, withdraw an accurately measured portion of the resultant solution, equivalent to about 1000 mg of cefotaxime, to a 100-mL volumetric flask, dilute with Solution A to volume, and mix. [NOTE—Do not rinse the syringe or container.] Dilute an accurately measured volume of this solution quantitatively with Solution A to obtain a solution having a concentration of about 0.8 mg of cefotaxime (C16H17N5O7S2) per mL. [NOTE—Use this solution promptly. It may be used within 24 hours if stored in the refrigerator.]

Procedure— Proceed as directed for Procedure in the Assay under Cefotaxime Sodium. Calculate the quantity, in µg, of cefotaxime (C16H17N5O7S2) in each mg of the Cefotaxime for Injection taken by the formula: in which W is the weight, in mg, of the Cefotaxime for Injection taken, and the other terms are as defined therein. Calculate the quantity, in mg, of cefotaxime in the container, and in the portion of constituted solution taken by the formula: in which L is the labeled quantity, in mg, of cefotaxime in the container, or in the volume of constituted solution taken; and D is the concentration, in mg per mL, of cefotaxime in Assay preparation 2 or in Assay preparation 3, or in Assay preparation 4, on the basis of the labeled quantity in the container, or in the portion of constituted solution taken, respectively; and the extent of dilution, and the other terms are as defined therein. Where the test for Uniformity of dosage units has been performed using the Procedure for content uniformity, use the average of these determinations as the Assay value.