Study on drug substance degradation under headspace GC conditions of residual solvent analysis

Abstract

Isobutyraldehyde (IBA) was detected in drug substance (DS) containing an amino acid group using a headspace-gas chromatography (HS-GC) method. High-performance liquid chromatography-mass-spectrometry (HPLC-MS) data from an HS vial confirmed that IBA was a degradant. The HS-GC method was modified to minimize IBA by keeping the HS oven temperature lower than 80 °C.