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Analytical guidelines such as ICH Q2(R2) discuss validation elements for procedures used to measure identity, purity, impurities, and other attributes [11]
After Reconstitution Reconstituted Sermorelin in BAC water should be: Stored at 2 to 8C (standard refrigerator, not the door where temperature fluctuates) Used within 30 days of reconstitution Kept away from light (opaque bag or dark drawer shelf inside the refrigerator works) Peptide stability data published in the Journal of Pharmaceutical Sciences demonstrate that GHRH analogues in benzyl-alcohol-preserved solutions retain greater than 95% purity at 4C for 28 days but drop below 90% purity within 14 days at 25C [7]
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Balenovic D et al
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