Protamine Sulfate in the EU: Analytical Validation, FinishedForm Control and Regulatory Pathways

Protamine sulfate is an argininerich polypeptide used as the clinical antidote to heparin and as a functional excipient in selected parenteral and combination products. Its mechanism of action is electrostatic binding to negatively charged heparin, forming stable complexes that rapidly neutralise anticoagulant activity. Clinically, protamine is employed primarily in cardiovascular and surgical settings, including cardiopulmonary […]