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

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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.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Pre-clinic Human Medicine > BioMedical Research (DBMR) > Unit Childrens Hospital > Forschungsgruppe Nephrologie / Hypertonie
04 Faculty of Medicine > Department of Dermatology, Urology, Rheumatology, Nephrology, Osteoporosis (DURN) > Clinic of Nephrology and Hypertension
04 Faculty of Medicine > Department of Gynaecology, Paediatrics and Endocrinology (DFKE) > Clinic of Endocrinology, Diabetology and Clinical Nutrition

UniBE Contributor:

Stettler, Christoph; Vogt, Bruno; Bally, Lia Claudia and Grössl, Michael

Subjects:

600 Technology > 610 Medicine & health

ISSN:

1520-9156

Publisher:

Mary Ann Liebert

Language:

English

Submitter:

Laura Goetschi

Date Deposited:

06 Nov 2020 15:34

Last Modified:

10 Nov 2020 09:02

Publisher DOI:

10.1089/dia.2019.0412

PubMed ID:

32031881

Uncontrolled Keywords:

Analogs Insulin Mass spectrometry Quality assurance Therapeutic aspects

BORIS DOI:

10.7892/boris.147857

URI:

https://boris.unibe.ch/id/eprint/147857

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