USP & Ph. Eur.
USP <1503> and Ph. Eur. peptide monographs describe expected assay, related substances and water content tests for clinical peptide APIs. Research-grade compounds borrow the analytical playbook even without the regulatory submission.
ISO 17025-aligned analytical practice
Method validation, calibration traceability, qualified instruments, controlled environment, and documented competence of analysts.
What Regena does
We commission third-party HPLC + MS testing aligned to these analytical practices and publish the raw reports. We do not claim cGMP or ISO certification for ourselves; our partners and labs do.
Frequently asked questions
Are you ISO certified?+
Our analytical partners operate to ISO-17025-aligned practice; Regena Peptides publishes their reports. We do not claim our own ISO certification.