Method for the analysis of related substances in germinal peptide preparation

Abstract

A method for analysis of related substances in a germinal peptide preparation is provided. The method refers to high-performance liquid chromatography (HPLC), and the HPLC is conducted under the following chromatographic conditions: a chromatographic column: a YMC-Triart C18 chromatographic column, 4.6×150 mm, 3 μm; a column temperature: 35° C.; an injection volume: 100 μL; a detection wavelength: 210 nm; a mobile phase A: a 0.1% trifluoroacetic acid (TFA) aqueous solution; a mobile phase B: 0.1% TFA-acetonitrile; and gradient elution as follows: 0 min: a volume ratio of the mobile phase A to the mobile phase B is 100:0; 8 min to 13 min: the volume ratio of the mobile phase A to the mobile phase B is 85:15; and 13 min to 20 min: the volume ratio of the mobile phase A to the mobile phase B is 100:0.

Dependencies are inferred from the claim text.