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Clinical Pharmacology Considerations for Peptide Drug Products: Guidance for Industry
Storage temperature consistency Optimal: 2-8C (36-46F) constant Temperature fluctuations shorten shelf life: Frequent door opening warms vials temporarily Power outages or fridge malfunctions Storing in fridge door (warmest, most variable location) Best practice: Store in main fridge section (not door) Middle or back of shelf (most stable temperature) Away from freezer section (avoid freezing) Avoid frequent removal for extended periods Light exposure Peptides degrade faster with light exposure, especially UV light
Scott R, MacPherson A, Yates RW, Hussain B, Dixon J
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What are the considerations for intravenous Vitamin B12 administration
Naunyn Schmiedebergs Arch Pharmacol
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