Shelf Life
The period during which a pharmaceutical product remains within its approved quality specifications when stored under recommended conditions. Shelf life is determined by stability testing data. Lyophilised peptides generally have longer shelf lives (1-3 years) than liquid peptide formulations.
Technical Context
Shelf life is determined from real-time stability data: the point at which the lower 95% confidence limit of the stability parameter (purity, potency) crosses the specification limit. ICH Q1E provides statistical methods for shelf-life estimation from stability data. Typical shelf lives: lyophilised peptide products (18-36 months at 2-8°C), liquid peptide formulations (12-24 months at 2-8°C), and some room-temperature-stable formulations (up to 24 months at 25°C). After first use (multi-dose products): semaglutide pen 6 weeks at room temperature or refrigerated; reconstituted lyophilised peptides 28 days with BWFI at 2-8°C. Expired peptide products should not be used — degradation products may be present that reduce efficacy or potentially cause adverse effects. Pharmaceutical stability programmes continue testing beyond the established shelf life to generate supporting data for potential shelf-life extensions.