Effect of Sample Vials on Analyte Stability in Pharmaceuticals

This technical report investigates the impact of different types of sample vials on the stability of pharmaceutical analytes during liquid chromatography (LC) analysis. It specifically examines how vial selection can influence the degradation of two small molecule pharmaceuticals, drospirenone and lovastatin. The report outlines that certain vials, particularly standard glass vials, can lead to non-specific adsorption and degradation of active pharmaceutical ingredients (APIs), resulting in out of specification (OOS) results during quality control processes. The study compares the performance of polyethylene vials and specially treated TruView pH Control LCMS Certified Vials against standard glass vials. Results indicate that the treated vials minimize degradant formation due to their low levels of leachable sodium, which helps maintain a stable pH and reduces the potential for base-catalyzed degradation. The findings underscore the importance of vial selection in ensuring accurate and reliable pharmaceutical assays.