Cefepime for Injection

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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1 DEFINITION

Cefepime for Injection is a sterile mixture of Cefepime Hydrochloride and Arginine. It contains the equivalent of NLT 90.0% and NMT 115.0% of the labeled amount of cefepime (C₁₉H₂₄N₆O₅S₂).

2 IDENTIFICATION

A. THIN-LAYER CHROMATOGRAPHIC IDENTIFICATION TEST 〈201〉

Standard solution: 20 mg/mL of arginine

Sample solution: 40 mg/mL of Cefepime for Injection

Developing solvent system: n-Propyl alcohol, ammonium hy droxide, and water (7:4:5) Analysis

Samples: Standard solution and Sample solution

Proceed as directed in  〈201〉, except to spray the plate with ninhy drin TS.

Acceptance criteria: Arginine appears as a dark red spot. The intensity and the R value of the spot from the Sample solution correspond to those from the Standard solution.

B. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.

Add the following:

C. The UV spectrum of the cefepime peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay. (USP 1-May-2021)

3 ASSAY

Change to read:

PROCEDURE

Solution A: 0.68 mg/mL of monobasic potassium phosphate in water

Solution B: Acetonitrile and Solution A (1:9), adjusted with 2% phosphoric acid or 2% potassium hydroxide to a pH of 5.0 Solution C: Acetonitrile and Solution A (1:1), adjusted with 2% phosphoric acid or 2% potassium hy droxide to a pH of 5.0 Mobile phase: See Table 1.