Europe Revises Monographs for Gonadotropins: Higher Purity Standards on the Horizon

The European Pharmacopoeia (Ph. Eur.) has initiated a revision process for monographs related to urinary gonadotropins (e.g., Menotrophin, Chorionic Gonadotrophin). The proposed changes include stricter limits for host cell proteins, viral safety documentation, and batch potency testing. While these requirements raise the bar for urinary-derived API producers, they also enhance product quality and market credibility. Manufacturers that have already invested in multi-step chromatography and viral inactivation steps will find themselves ahead of the curve.