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
(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
Sample Name Index
Operation Manual / Certificate of Analysis
Operation Manuals and Certificate of Analysis / Inspection Certificate for the following products can be downloaded here.