Research Peptide Glossary

HPLC is the analytical technique used to determine the purity of a peptide compound, expressed as the integrated chromatographic peak area relative to total area and reported as a percentage.

A Certificate of Analysis is a third-party laboratory document that records the identity, purity, and storage specifications of a specific production batch of a compound.

Research Use Only is the regulatory designation applied to compounds sold for in vitro scientific research and not for use in humans or animals.

USP General Chapter <797> is the U.S. Pharmacopeia standard for sterile compounding — applicable to sterile compounded preparations such as injectables, ophthalmics, and IV admixtures.

USP General Chapter <795> is the U.S. Pharmacopeia standard for non-sterile compounding — applicable to oral, topical, and other non-sterile compounded preparations.

Section 503A of the U.S. Federal Food, Drug, and Cosmetic Act governs traditional compounding pharmacies that dispense patient-specific prescriptions of compounded drugs.

Section 503B of the U.S. Federal Food, Drug, and Cosmetic Act governs outsourcing facilities that compound sterile drugs for distribution without patient-specific prescriptions.

An Active Pharmaceutical Ingredient is the substance in a drug product responsible for its physiological effect — the compound itself, before it is incorporated into a finished dosage form.

Solid-Phase Peptide Synthesis is a method for chemically constructing a peptide chain by anchoring the first amino acid to an insoluble resin and adding subsequent amino acids in sequence.