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Description

Physical signs that a reconstituted injectable solution may have degraded include: Visible particulate matter cloudiness, floating particles, or sediment that does not clear upon gentle swirling Discolouration any yellowing, browning, or change from the expected clear, colourless appearance Change in consistency a gel-like or unusually viscous texture may suggest protein aggregation Any unusual odour upon opening, which may indicate contamination Importantly, chemical degradation including oxidation, deamidation, or hydrolysis of peptide bonds can occur without any visible change to the solution (EMA/ICH Q5C guideline on stability of biotechnological products)

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