Senior Research Scientist Research Center Pharmaceutical Engineering Graz, Steiermark, Austria
Quantitative Nuclear Magnetic Resonance (qNMR) has become indispensable in pharmaceuticals for accurately quantifying Active Pharmaceutical Ingredients (APIs) and excipients in both innovative and generic products. It excels by directly measuring compounds without reference standards, crucial for complex matrices. In innovative pharmaceuticals, qNMR ensures precise control over formulation composition, guaranteeing product quality and performance. For generics, qNMR is vital for assessing bioequivalence and adhering to established formulations, enabling thorough analysis of API and excipient levels to meet regulatory Q1/Q2 equivalence requirements. This method supports consistency and compliance in pharmaceutical production, enhancing confidence in product quality and regulatory approval processes. Overall, qNMR's direct quantification capability underscores its versatility and accuracy, benefiting diverse pharmaceutical applications by streamlining analytical workflows and bolstering confidence in formulation and manufacturing processes.
Learning Objectives:
Upon completion, participants will learn qNMR to precisely quantify excipients in pharmaceutical formulations, demonstrating versatility across tablets/prefilled syringes. Insights aid in generic development and compliance with regulatory Q1/Q2 parameters.
