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Injectable routes carry a particular concern for immunogenicity from peptide aggregation and impurities, and FDA noted the available certificates of analysis for AOD-9604 bulk drug substances did not consistently control for impurities, aggregates, or microbial limits

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Czechia Greater than 99.8 % purity confirmed by COA Assay content verified at 124.6 mg Identity confirmed through MS Deconvolution Endotoxin level below 0.001 EU/mg No detectable heavy metals or microbial contamination For research use only not for human or veterinary use For laboratory research only

Non-blue colors (green, brown) indicate degradation requiring disposal