Abstract
This study aimed to evaluate the chemical stability of sincalide at two common storage conditions; room temperature and refrigeration in an attempt to simulate the conditions faced during centralized reconstitution and subsequent distribution to regional clinical facilities. Sincalide is a peptide hormone product administered parenterally as an aid for diagnostic imaging of hepatobiliary conditions. With an estimated post‐reconstitution shelf‐life of 8 hours (updated by the manufacturer in 2014 with limited supporting data) and frequent shortages due to intermittent supply, there is both clinical and economic value in the experimental determination of true chemical stability of this agent. Methods: Sincalide was reconstituted and stored at both temperatures (n = 4 each) and samples were collected at pre‐determined time points. A validated HPLC (high performance liquid chromatography) analytical method was employed for quantification of the active ingredient in these samples. Results: Little to no chemical degradation of sincalide was observed for the duration of study, over 8 days, following reconstitution and storage at room temperature. A trend of cyclic fluctuation in concentration was also shared between all samples. A similar trend of little to no chemical degradation and cyclic pattern was observed for the duration of study, over 8 days, following reconstitution and storage in refrigeration. Conclusion: This study supports that from a chemical standpoint, sincalide may potentially be used up to at least 8 days following reconstitution with sterile water, thus providing convenient and cost‐saving benefits to medical institutions utilizing the product. The findings of this study, however, warrants microbial testing over this storage duration before any recommendations for extended usage can be made.