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. Using the same condition, we analyzed povidone K-30. The elution of formic acid was observed by comparing the elution position of the formic acid standard.


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
Povidone K-30 20 mg/mL
Standard solution (Formic acid aq. 0.01 mg/mL)

  1. 1.Formic acid
Chromatogram of formic acid in povidone
Shodex RSpak KC-811 (8.0 mm I.D. x 300 mm)
Diluted HClO4 (70 %) (1 in 700)
Flow rate
1.0 mL/min
UV (210 nm)
Column temp.
35 ℃

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