Cefotetan Disodium

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

Cefotetan Disodium contains the equivalent of NLT 830 µg/mg and NMT 970 µg/mg of cefotetan (C₁₇H₁₇N₇O₈S₄), 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, Sodium〈191〉: Meets the requirements

3 ASSAY

3.1 PROCEDURE

Protect the Standard solution, the System suitability solution, and the Sample solution from light, and use within 2 h. Mobile phase: Methanol, acetonitrile, glacial acetic acid, and 0.1 M phosphoric acid (105:105:100:1700)

Standard solution: 0.2 mg/mL of USP Cefotetan RS in methanol, acetonitrile, and water (5:5:90), prepared as follows. Place a suitable quantity of USP Cefotetan RS in a suitable volumetric flask, and add methanol, using 5% of the final volume. Swirl for several min, and add acetonitrile, using 5% of the final volume. Swirl until dissolved, and dilute with water to volume.

System suitability solution: Transfer 10 mL of Standard solution to a glass-stoppered flask containing a few mg of magnesium carbonate. Sonicate for 10 min. If the solution is not turbid, add a few more mg of magnesium carbonate, and repeat the sonication. Pass the turbid solution through a filter of 0.5-µm or finer pore size. Use the clear filtrate.

Sample solution: 0.2 mg/mL of Cefotetan Disodium in methanol, acetonitrile, and water (5:5:90), prepared as follows. Place a suitable quantity of Cefotetan Disodium in a suitable volumetric flask, and add methanol, using 5% of the final volume. Swirl for several min, and add acetonitrile, using 5% of the final volume. Swirl until dissolved, and dilute with water to volume.

3.1.1 Chromatographic system

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

Detector: UV 254 nm

Column: 4.6-mm × 25-cm; packing L1 Flow rate: 2 mL/min

Injection volume: 20 µL

3.1.2 System suitability

Samples: Standard solution and System suitability solution

[NOTE—The relative retention times for cefotetan and cefotetan tautomer are 0.75 and 1.0, respectively.]

Suitability requirements

Resolution: NLT 2.0 between cefotetan and cefotetan tautomer, System suitability solution Column efficiency: NLT 1500 theoretical plates, Standard solution

Tailing factor: NMT 1.5, Standard solution

Relative standard deviation: NMT 2.0%, Standard solution

3.1.3 Analysis

Samples: Standard solution and Sample solution

Calculate the quantity, in µg/mg, of cefotetan (C₁₇H₁₇N₇O₈S₄) in the portion of Cefotetan Disodium taken:

Result = (r_u/r_s) × (C_s/C_u) × P

r_u = peak response from the Sample solution

r_s = peak response from the Standard solution

C_s = concentration of USP Cefotetan RS in the Standard solution (mg/mL)

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

P = potency of cefotetan in USP Cefotetan RS (µg/mg) Acceptance criteria: 830–970 µg/mg on the anhydrous basis

4 SPECIFIC TESTS

PH 〈791〉

Sample solution: 100 mg/mL Acceptance criteria: 4.0–6.5

WATER DETERMINATION, Method Ic〈921〉: NMT 2.5%

STERILITY TESTS 〈71〉: Where the label states that Cefotetan Disodium is sterile, it meets the requirements when tested as directed for Test for Sterility of the Product to Be Examined, Membrane Filtration.

BACTERIAL ENDOTOXINS TEST 〈85〉: Where the label states that Cefotetan Disodium is sterile or it must be subjected to further processing during the preparation of injectable dosage forms, it contains NMT 0.17 USP Endotoxin Unit/mg of cefotetan.

5 ADDITIONAL REQUIREMENTS

PACKAGING AND STORAGE: Preserve in tight containers.

LABELING: Where it is intended for use in preparing injectable dosage forms, the label states that it is sterile or must be subjected to further processing during the preparation of injectable dosage forms.

USP REFERENCE STANDARDS 〈11〉

USP Cefotetan RS