Floxuridine 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

Floxuridine for Injection is lyophilized Floxuridine suitable for intra-arterial infusion. It contains NLT 90.0% and NMT 110.0% of the labeled amount of floxuridine (C₉H₁₁FN₂O₅).

2 IDENTIFICATION

Change to read:

A. Spectroscopic Identification Tests 〈197〉, Ultraviolet-Visible Spectroscopy: 197U_{(CN 1-May-2020)}

Sample: Use the Sample solution prepared for the Assay.

Acceptance criteria: Meets the requirements

B.

Sample solution: Nominally 20 mg/mL of floxuridine in water

Analysis: Add a few drops of bromine TS to 10 mL of the Sample solution.

Acceptance criteria: The bromine color is discharged.

3 ASSAY

Procedure

Diluent: Potassium hydroxide solution (1 in 180)

Standard solution: 20 µg/mL of USP Floxuridine RS in Diluent

Sample stock solution: Nominally 0.4 mg/mL of Floxuridine for Injection in Diluent

Sample solution: 20 µg/mL from the Sample stock solution in Diluent

Blank: Diluent

3.1 Instrumental conditions

Mode: UV

Analytical wavelength: 268 nm

Cell: 1 cm

3.2 Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of floxuridine (C H FN O ) in the portion of Floxuridine for Injection taken: 9 11 2 5

Result = (A_U /A_S ) × (C_S /C_U ) × 100

A_U = absorbance of the Sample solution

A_S = absorbance of the Standard solution

C_S = concentration of USP Floxuridine RS in the Standard solution (µg/mL)

C_U = nominal concentration of floxuridine in the Sample solution (µg/mL)

Acceptance criteria: 90.0%–110.0%

4 PERFORMANCE TESTS

Uniformity of Dosage Units 〈905〉: Meets the requirements

5 SPECIFIC TESTS

pH 〈791〉

Sample solution: 1 in 50

Acceptance criteria: 4.0–5.5

Constituted Solution: Meets the requirements in Injections and Implanted Drug Products 〈1〉, Specic Tests, Completeness and clarity of solutions

Pyrogen: Meets the requirements of Pyrogen Test 〈151〉, the test dose being 0.50 mL/kg of a solution prepared by diluting Floxuridine for Injection with Sodium Chloride Injection to a concentration of 100 mg/mL

Other Requirements: Meets the requirements in Injections and Implanted Drug Products 〈1〉

6 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve as described in Packaging and Storage Requirements 〈659〉, Injection Packaging, and protect from light. Store containers of constituted Floxuridine for Injection under refrigeration for NMT 2 weeks.

USP Reference Standards 〈11〉

USP Floxuridine RS