Packaging and storage— Preserve in Containers for Injectionsas described under Injections á1ñ,protected from light.Store containers of constituted Floxuridine for Injection under refrigeration for not more than 2weeks.

USP Reference standards á11ñ— USP Floxuridine RS.

Constituted solution— It meets the requirements for Constituted Solutionsunder Injections á1ñ.

Identification—

Pyrogen— It meets the requirements of the Pyrogen Test á151ñ,the test dose being 0.50mLper kg of a solution prepared by dilution of Floxuridine for Injection with Sodium Chloride Injection to a concentration of 100mg per mL.

Uniformity of dosage units á905ñ: meets the requirements.

pHá791ñ: between 4.0and 5.5,in a solution (1in 50).

Other requirements— It meets the requirements under Injections á1ñ.

Assay— Transfer about 100mg of Floxuridine for Injection,accurately weighed,to a 250-mLvolumetric flask,dissolve in and dilute with potassium hydroxide solution (1in 180)to volume,and mix.Transfer 5.0mLof this solution to a 100-mLvolumetric flask,dilute with potassium hydroxide solution (1in 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 20µg per mL,in 1-cm cells at the wavelength of maximum absorbance at about 268nm,with a suitable spectrophotometer,using potassium hydroxide solution (1in 180)as the blank.Calculate the quantity,in mg,of C9H11FN2O5in the portion of Floxuridine for Injection taken by the formula: in which Cis the concentration,in µg per mL,of USP Floxuridine RSin the Standard solution;and AUand ASare the absorbances of the solution from Floxuridine for Injection and the Standard solution,respectively.

Expert Committee:(PA7)Pharmaceutical Analysis 7

USP28–NF23Page 828

Phone Number:1-301-816-8394