Packaging and storage— Preserve in Containers for Injections as described under Injections 1, protected from light. Store containers of constituted Floxuridine for Injection under refrigeration for not more than 2 weeks.

USP Reference standards 11— USP Floxuridine RS.

Constituted solution— It meets the requirements for Constituted Solutions under Injections 1.

Identification—

Pyrogen— It meets the requirements of the Pyrogen Test 151, the test dose being 0.50 mL per kg of a solution prepared by dilution of Floxuridine for Injection with Sodium Chloride Injection to a concentration of 100 mg per mL.

Uniformity of dosage units 905: meets the requirements.

pH 791: between 4.0 and 5.5, in a solution (1 in 50).

Residual solvents 467: meets the requirements.

Other requirements— It meets the requirements under Injections 1.

Assay— Transfer about 100 mg of Floxuridine for Injection, accurately weighed, to a 250-mL volumetric flask, dissolve in and dilute with potassium hydroxide solution (1 in 180) to volume, and mix. Transfer 5.0 mL of this solution to a 100-mL volumetric flask, dilute with potassium hydroxide solution (1 in 180) to volume, and mix. Concomitantly determine the absorbances of this solution and a Standard solution of USP Floxuridine RS, in the same medium having a known concentration of about 20 µg per mL, in 1-cm cells at the wavelength of maximum absorbance at about 268 nm, with a suitable spectrophotometer, using potassium hydroxide solution (1 in 180) as the blank. Calculate the quantity, in mg, of C9H11FN2O5 in the portion of Floxuridine for Injection taken by the formula: in which C is the concentration, in µg per mL, of USP Floxuridine RS in the Standard solution; and AU and AS are the absorbances of the solution from Floxuridine for Injection and the Standard solution, respectively.

Expert Committee : (MDAA05) Monograph Development-Antivirals and Antimicrobials

USP29–NF24 Page 911

Phone Number : 1-301-816-8394