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Peptides such as CJC-1295 can be extremely sensitive to product formulation, process, and environmental conditions (e.g., pH, heat (temperature), concentration, in-process related impurities, excipients), which may lead to the aggregation and degradation of peptides, with consequent loss of biological activity and detecting the resulting aggregates may require specific analytical methods such as size exclusion chromatography or field flow fractionation [11]

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Finally, preclinical studies must have solely used animal models to investigate certain mechanistic parameters