How to Know When an Analytical Method is Fit-for-Purpose - Insights from NMR Case Studies

Intro

Regulatory guidance increasingly emphasizes analytical procedure understanding, performance‑based validation, and life‑cycle management. At the same time, growing drug‑modality complexity makes determining whether a method is truly fit‑for‑purpose more challenging. Nuclear Magnetic Resonance (NMR) spectroscopy stands out as an analytical technology, providing direct, absolute structural and quantitative information grounded in well‑defined physical principles. This supports enhanced analytical procedure life‑cycle management while offering the flexibility and robustness required by modern quality control concepts. Applied across the pharmaceutical industry, NMR addresses diverse analytical objectives and is particularly effective for polysaccharide analysis, enabling identity testing, impurity profiling, and linkage‑specific quantification from a single experiment, without derivatization or separation.

Webinar Overview

In this webinar, we examine how Nuclear Magnetic Resonance (NMR) spectroscopy supports analytically sound, fit‑for‑purpose methods across the pharmaceutical product life cycle, in line with evolving regulatory expectations for analytical procedure understanding. We highlight representative NMR applications ranging from early candidate screening and structure-activity relationship studies to data‑driven process understanding, optimization, and routine use from R&D through Quality Control.

A focused case study addresses the analytically challenging quantification of the α‑1,6 branching ratio in maltodextrin. Using an 80 MHz benchtop ¹H NMR spectrometer and a disaccharide model system, we illustrate how acquisition strategy, solvent suppression, and analysis mode directly impact method performance. Multiple analytical procedure performance assessment frameworks are applied and compared, demonstrating how framework selection influences fitness‑for‑purpose conclusions and supports informed, risk‑based development decisions in this analytically challenging case.

What to Expect

Discover how NMR is applied across pharmaceutical development and quality control to address complex analytical questions. Understand when and how NMR methods can be considered fit‑for‑purpose in practice. Gain a practical understanding of how to evaluate analytical performance using different assessment frameworks, and see how benchtop NMR can be used to tackle challenging quantitative applications under realistic, application‑driven conditions.

Key Learning Points

• NMR support of analytically justified methods across pharmaceutical R&D and Quality Control.
• Practical evaluation of analytical procedure performance using complementary assessment frameworks.
• Real‑world example of quantitative polysaccharide analytical procedure development and assessments using benchtop NMR.

Who Should Attend?

• Innovation leaders, scientific directors, analytical science experts, and QC laboratory managers exploring robust analytical technologies to address complex analytical challenges and support evolving regulatory expectations.
• Analytical scientists involved in CMC, R&D, or QC procedure development and implementation who want to better understand how NMR can be applied and assessed to support fit‑for‑purpose methods across the product life cycle.
• Regulatory and compliance professionals seeking practical insight into the application of modern analytical technologies, in the context of method performance evaluation and life‑cycle management.

Speaker: Christina Szabo, Ph.D. (Founder, Szabo Scientific Consulting LLC)

Christina Szabo is a scientific and analytical leader with broad experience in the pharmaceutical and medical device industries and expertise in NMR applications. She most recently served as Associate Director of Analytical Chemistry and Stability in R&D, where she led global teams supporting analytical chemistry, stability, mass spectrometry, extractables and leachables, elemental impurities, and related analytical strategies for healthcare products. Earlier in her career, she led advanced analytical capabilities in a centralized organization, with extensive application of NMR to complex analytical and investigational challenges. She earned her Ph.D. in Chemistry from the University of Illinois Urbana-Champaign, following earlier research in marine natural products chemistry at the University of Hawaii. She is a long-standing expert volunteer with the United States Pharmacopeia and currently serves on the Non-Botanical Dietary Supplements Expert Committee and is Chair of the Modern Analytical Methods Joint Subcommittee.