Cefoperazone Sodium

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

Cefoperazone Sodium contains the equivalent of NLT 870 µg/mg and NMT 1015 µg/mg of cefoperazone (C₂₅H₂₇N₉O₈S₂), calculated on the anhydrous basis.

2 IDENTIFICATION

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

 B. IDENTIFICATION TESTS—GENERAL 〈191〉 , Chemical Identification Tests, Sodium: Meets the requirements

3 ASSAY

Change to read:

3.1 PROCEDURE

Solution A: Place 14 mL of triethylamine and 5.7 mL of glacial acetic acid in a 100-mL volumetric flask, and dilute with water to volume. Mobile phase: Acetonitrile, ▲1 M acetic acid TS,▲ (USP 1-Dec-2023) Solution A, and water (120: 2.8: 1.2: 876)

Standard solution: 0.16 mg/mL of cefoperazone from USP Cefoperazone Dihy drate RS in Mobile phase

Sample solution: 0.16 mg/mL of cefoperazone from Cefoperazone Sodium in Mobile phase

3.1.1 Chromatographic system

(See Chromatography 〈621〉, System Suitability.) Mode: LC

Detector: UV 254 nm

Column: 3.9-mm (USP 1-Dec-2023) × 30-cm; 10-μm (USP 1-Dec-2023) packing L1 Flow rate: 2 mL/min

Injection volume: 10 µL

3.1.2 System suitability

Sample: Standard solution Suitability requirements

Tailing factor: NMT 1.5

Relative standard deviation: NMT 0.73% (USP 1-Dec-2023)

3.1.3 Analysis

Samples: Standard solution and Sample solution

Calculate the quantity, in μg/mg, of cefoperazone (C H N O S ) in the portion of Cefoperazone Sodium taken:

Result = (r_u/r_s) × (C_s/C_u) × P

r_u = peak response of cefoperazone from the Sample solution

r_s = peak response of cefoperazone from the Standard solution

C_s = concentration of cefoperazone in the Standard solution (mg/mL)

C_u = concentration of cefoperazone in the Sample solution (mg/mL)

P = potency of cefoperazone in USP Cefoperazone Dihydrate RS (µg/mg) Acceptance criteria: 870–1015 µg/mg on the anhydrous basis

4 SPECIFIC TESTS

CRYSTALLINITY 〈695〉: Meets the requirements

PH 〈791〉

Sample solution: 250 mg/mL of Cefoperazone Sodium in water Acceptance criteria: 4.5–6.5

WATER DETERMINATION 〈921〉 , Method I: NMT 5.0%

Delete the following:

STERILITY TESTS 〈71〉▲ (USP 1-Dec-2023)

Delete the following:

BACTERIAL ENDOTOXINS TEST 〈85〉 (USP 1-Dec-2023)

5 ADDITIONAL REQUIREMENTS

PACKAGING AND STORAGE: Preserve in tight containers. Delete the following:

LABELING (USP 1-Dec-2023)

USP REFERENCE STANDARDS 〈11〉

USP Cefoperazone Dihydrate RS