Cefotaxime for Injection
» Cefotaxime for Injection contains an amount of Cefotaxime Sodium equivalent to not less than 90.0 percent and not more than 115.0 percent of the labeled amount of cefotaxime (C16H17N5O7S2).
Packaging and storage— Preserve in Containers for Sterile Solids as described under Injections 1.
Constituted solution— At the time of use, it meets the requirements for Constituted Solutions under Injections 1.
Identification—
Where the label indicates that there are no added substances
B: It responds to the tests for Sodium 191.
Where the label indicates that there are added substances
C: It responds to Identification test B under Cefotaxime Sodium.
Bacterial endotoxins 85 It contains not more than 0.20 USP Endotoxin Unit per mg of cefotaxime.
Sterility 71 It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined.
Uniformity of dosage units 905
Procedure— Perform the Assay on individual containers using Assay preparation 2, Assay preparation 3, or Assay preparation 4, as appropriate.
Particulate matter 788: meets the requirements for small-volume injections.
Chromatographic purity— Using the chromatogram of the Assay preparation obtained in the Assay, calculate the percentage of each impurity by the formula:
100ri / (ris + rc)
in which ri is the peak area response of a given impurity; ris is the sum of all the impurity peak area responses; and rc is the peak area response for the main cefotaxime peak. [note—Disregard any impurity peak that is less than 0.1%.] Not more than 6.0% of any individual impurity is found, and the sum of all impurities found is not more than 10.0%.
Other requirements— It meets the requirements for pH and Loss on drying under Cefotaxime Sodium and for Labeling under Injections 1.
Assay—
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:
50(CP / W)(rU / rS)
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:
(CP)(L/1000D)(rU / rS)
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.
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Topic/Question Contact Expert Committee
Monograph Ahalya Wise, M.S.
Scientist
1-301-816-8161
(MDANT05) Monograph Development-Antibiotics
Reference Standards Lili Wang, Technical Services Scientist
1-301-816-8129
RSTech@usp.org
85 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
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(MSA05) Microbiology and Sterility Assurance
71 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
1-301-816-8339
(MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 1845
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.