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TR 2021/238: 4040/40 Lyophilization Stoppers - Aging and Gamma Irradiation Study
Assessment of physicochemical and physical changes in the component as per the baseline evaluations included in the EP, JP, and USP.
This document summarizes the physicochemical, functional, and bioreactivity data generated on 4040/40 Gray Lyophilization stoppers after gamma irradiation and storage at an elevated temperature for up to 12 months.
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