Analysis of Urea, an Impurity in Fluorouracil Injection, Proposed in USP-NF Pharmacopeial Forum (SB-802.5 HQ)

According to the United States Pharmacopeia and the National Formulary Pharmacopeial Forum (PF 47(3)*) ,analysis of urea, an impurity in fluorouracil injection, is proposed to be carried out with a column filled with L39 packing material and meets following requirements. The SB-802.5 HQ confirmed the requirements were met.

System suitability requirements:
  Tailing factor of urea: ≤ 2.0
  Relative standard deviation(RSD): ≤ 3.0 %

*The version at the time of the application acquisition.

Sample : 50 μL
Urea 0.5 mg/mL

Column       : Shodex OHpak SB-802.5 HQ (8.0 mm I.D. x 300 mm)
Eluent       : 12.7 g/L of Sodium nitrate with 0.1%(v/v) of Triethylamine in Water
Flow rate    : 0.8 mL/min
Detector     : RI
Column temp. : 35 °C 

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