Quality Assurance of Commercial Insulin Formulations: Novel Assay Using Infrared Spectroscopy.

ABSTRACT:

Background

For insulins in commercial formulations, degradation can be observed within the certified shelf life when not stored at recommended conditions. Elevated temperatures and exposure to shear forces can cause changes in the secondary structure of the hormone, leading to a decrease in pharmaceutical potency. International pharmacopoeia recommendations for insulin quality monitoring assays mainly rely on liquid chromatography methods. These methods are unable to distinguish between active and inactive forms, both of which may exist in pharmaceutical insulins exposed to stress conditions.

Method

Infrared attenuated total reflection spectroscopy has been used for the analysis of insulin dry film preparations using affordable instrumentation. This method can be applied to

SUBMITTER: Delbeck S 

PROVIDER: S-EPMC8252148 | biostudies-literature | 2021 Jul

REPOSITORIES: biostudies-literature