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Leachables

November 10, 2025

Through the Lens of GC/QTOF: Tracking Down Impurities in Ophthalmics

Blog Post 9 – Through the Lens of GC/QTOF: Tracking Down Impurities in Ophthalmics 3 min reading time In the development of ophthalmic drug products, impurity profiling is essential to ensure long-term safety and regulatory compliance. While many impurities are...

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November 3, 2025

The Case of the Vanishing Thickness: How NMR Solves the Impurity Mystery

Blog Post 8 – The Case of the Vanishing Thickness: How NMR Solves the Impurity Mystery 2 min reading time In pharmaceutical manufacturing, even the smallest modifications to packaging can have significant consequences. In a recent project, a minor reduction...

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October 27, 2025

When Formulation Tweaks Reveal Hidden Chemistry: A Case of Unexpected Impurities

Blog Post 7 – When Formulation Tweaks Reveal Hidden Chemistry: A Case of Unexpected Impurities 2 min reading time Recently, a customer reformulated a drug product containing a well-characterized Active Pharmaceutical Ingredient (API). Routine High-Performance Liquid Chromatography/Ultraviolet (HPLC/UV) analysis flagged...

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October 20, 2025

Database-driven discovery: how NIST23 helped trace a manufacturing impurity

Blog Post 6 – Database-driven discovery: how NIST23 helped trace a manufacturing impurity 2 min reading time Impurity identification primarily depends on mass spectrometric analysis and comparison with reference MS spectra. In most cases, impurities are identified by matching spectra...

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October 13, 2025

A spectrum of clues: identifying residual solvent impurities using diverse analytical tools

Blog Post 5 – A spectrum of clues: identifying residual solvent impurities using diverse analytical tools 2 min reading time Figure 1: Overview of different techniques used to identify the unknown In pharmaceutical manufacturing, controlling impurities is essential to ensure...

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