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Peptide Quality Standards

Meaning

Peptide Quality Standards are the comprehensive set of stringent criteria, specifications, and analytical testing protocols applied throughout the manufacturing, purification, and formulation of therapeutic peptides to ensure their identity, purity, potency, and safety for clinical use. These standards dictate the minimum acceptable level of the active peptide and the maximum allowable limits for impurities, such as truncated sequences, residual solvents, and microbial contaminants. Adherence is non-negotiable for patient safety and efficacy.