Analysis of Formic Acid in Povidone According to Pharmacopeia Method (KC-811)

According to the Japanese Pharmacopeia (JP; 17th edition*), the United States Pharmacopeia and the National Formulary (USP43-NF38*), and the European Pharmacopoeia (EP 10.4*), analysis of formic acid in povidone should be carried out with a method that meets following requirements. The RSpak KC-811 confirmed the requirements were met.

System suitability requirements:
   Theoretical plate number: ≥ 1,000
   Symmetry factor: 0.5 – 1.5
   Relative standard deviation (RSD) of six analyses: ≤ 2.0%

*The version at the time of the application acquisition.

Sample : 50 μL
Standard solution
(Formic acid aq. 0.01 mg/mL)
1. Formic acid

Column       : Shodex RSpak KC-811 (8.0 mm I.D. x 300 mm) 
Eluent       : Diluted HClO4(70 %) (1 in 700)
Flow rate    : 1.0 mL/min
Detector     : UV (210 nm)
Column temp. : 35 °C

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