Research
Scientific articles on peptide research, documentation, purity, and traceability.
Alpha Research
Science
Peptide Compounding: 503A vs. 503B Designations, USP <797> Compliance, and the Current Regulatory Debate
Analysis of peptide compounding regulatory framework: 503A/503B differences, USP <797> compliance parameters (sterility testing, endotoxin, BUD), GLP-1R agonist restriction debate, and research distribution boundaries.
Alpha Research
Science
Peptides in Clinical Development: Phase 1-3 Pipeline, Endpoint Design, and Key Regulatory Milestones
Overview of peptide clinical development: Phase 1-3 trial design, primary/secondary endpoint selection criteria, FDA/EMA regulatory milestones, and the current therapeutic peptide pipeline.
Alpha Research
Fundamentals
Clinical-Grade Peptide Supply Chains: Documentation, Traceability, and CoA Standards
Analysis of criteria defining a research-grade peptide supply chain: lot documentation standards, required analytical methods (HPLC, MS, LAL), endotoxin control, cold-chain custody, and minimum elements of a defensible certificate of analysis for preclinical and regulatory environments.