Concentration and Chemical Stability of Commercially Available Insulins: A High-Resolution Mass Spectrometry Study.

Baechler, Fabio; Stettler, Christoph; Vogt, Bruno; Bally, Lia; Groessl, Michael (2020). Concentration and Chemical Stability of Commercially Available Insulins: A High-Resolution Mass Spectrometry Study. Diabetes technology & therapeutics, 22(4), pp. 326-329. Mary Ann Liebert 10.1089/dia.2019.0412

	Text doi_10.1089_dia.2019.0412.pdf - Published Version Restricted to registered users only Available under License Publisher holds Copyright. Download (129kB) | Request a copy
Preview	Text LB_10.1089_DIA-2019-0412_Manuscrip_R1_clean.pdf - Accepted Version Available under License Publisher holds Copyright. Download (250kB) | Preview

Adequacy of insulin concentration in commercially available insulin formulations has recently been challenged. We therefore repeatedly evaluated insulin content and stability of 58 insulin vials containing 5 different insulin formulations (human insulin, standard/faster-acting insulin aspart, insulin lispro, and insulin glargine) over a period of 85 days. High-resolution mass spectrometry was used to quantify intact monomeric insulin in glass vials and plastic pump cartridges exposed to three different temperatures (4°C, 22°C, 37°C), simulating real-life conditions. In all cases, measured insulin concentration was in accordance with FDA and European Medicines Agency (EMA) requirements without evidence of chemical instability.

Interest & Impact

Downloads

33 since deposited on 06 Nov 2020
20 in the past 12 months

Citations

5 Citations in Web of Science ®
6 Citations in Scopus

Search

in Google Scholar™

Services

Actions (login required)

Edit item

Actions (login required)

Edit item