NMR Spectroscopy in Pharmaceutical Analysis
21CFR Part 11 of the GMPs requires the adequate control of manufacturing operations to ensure the safety, identity, strength, quality, and purity of drug products.
Therefore, each component of a final product – be it active pharmaceutical ingredients, excipients, fillers or coloring agents, needs to be tested during the drug development process and throughout the life cycle of the product.
NMR Spectroscopy has several uses in the pharmaceutical industry, from structure elucidation in early-stage molecule screening to batch release analysis of an API for purity, helping drug companies to ensure the production of effective and safe products.
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This article walks you through every aspect of this analysis technique, including:
- How it works
- What the spectrum provides
- Applications in the pharmaceutical industry
- The regulations