Cefepime Hydrochloride
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This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
1 DEFINITION
Cefepime Hydrochloride contains the equivalent of NLT 825 µg/mg and NMT 911 µg/mg of cefepime (C19H24N6O5S2), calculated on the anhydrous basis.
2 IDENTIFICATION
Change to read:
A. SPECTROSCOPIC IDENTIFICATION TESTS 〈197〉 , Infrared Spectroscopy: ▲197A, 197K, or▲ (USP 1-May-2024) 197M
Sample: Proceed as directed in the chapter, but do not dry. Acceptance criteria: Meets the requirements
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. IDENTIFICATION TESTS—GENERAL 〈191〉 , Chemical Identification Tests, Chloride: Meets the requirements▲ (USP 1-May-2024)
3 ASSAY
Change to read:
PROCEDURE
Solution A: 0.68 mg/mL of monobasic potassium phosphate in water
Solution B: Acetonitrile and Solution A (10:90). Adjust with 2% phosphoric acid or 2% potassium hy droxide to a pH of 5.0. Solution C: Acetonitrile and Solution A (50:50). Adjust with 2% phosphoric acid or 2% potassium hydroxide to a pH of 5.0. Mobile phase: See Table 1.
