Identification and characterization of chemical and physical stability of insulin formulations utilizing degraded glycerol after repeated use and storage was written by Sun, Min-Fei;Xu, Youfu;Yuan, Jun-Jie;Fang, Wei-Jie. And the article was included in European Journal of Pharmaceutics and Biopharmaceutics in 2022.Quality Control of 1,2-Propanediol This article mentions the following:
Insulin treatment is currently considered to be the main strategy for controlling diabetes. Although the recombinant insulin formulation is relatively mature, we found that a batch of insulin formulation exhibited an unusual degradation rate in the stability experiment The main purposes of this article are to identify the root cause for this phenomenon and characterize of chem. and phys. degradation products. We compared the chem. and phys. stability of two batches of insulin formulations prepared sep. with simulated repeated use and freshly opened glycerol. The chem. stability of insulin was identified by liquid chromatog. coupled with tandem mass spectrometry (LC- MS/MS). Micro-flow imaging (MFI), far-UV CD (Far-UV CD) and Thioflavin T (ThT) fluorescent assays were used to reveal protein aggregation and fibrosis. The chem. and phys. stability of the insulin formulation with newly opened glycerol was much better than that with degraded glycerol, and both groups of formulations were extremely sensitive to light. The results indicated that the original batch insulin formulation with abnormal stability was indeed caused by the excipient glycerol after long-term storage and repeated usage. More attention should be paid to the quality changes of excipients during repeated usage and storage of excipients for the practical purpose. Moreover, we have discovered a novel degradation pathway for insulin and peptides in general. In addition, LC-MS/MS results suggested that the N-terminus of insulin B-chain was prone to chem. degradation which enlightens that it could be potentially modified to improve the stability of insulin formulations. In the experiment, the researchers used many compounds, for example, 1,2-Propanediol (cas: 57-55-6Quality Control of 1,2-Propanediol).
1,2-Propanediol (cas: 57-55-6) belongs to alcohols. Because alcohols are easily synthesized and easily transformed into other compounds, they serve as important intermediates in organic synthesis. Grignard and organolithium reagents are powerful tools for organic synthesis, and the most common products of their reactions are alcohols.Quality Control of 1,2-Propanediol
Referemce:
Alcohol – Wikipedia,
Alcohols – Chemistry LibreTexts