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Leachables

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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October 6, 2025

When one dimension isn’t enough: unraveling impurities from secondary packaging

Blog Post 4 – When one dimension isn’t enough: unraveling impurities from secondary packaging 2 min reading time In our ongoing series on impurities in drug products, we encountered a compelling case that highlights the hidden risks of packaging changes—even...

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September 29, 2025

From fill line to fault line: tracing impurities in drug manufacturing

Blog Post 3 – From fill line to fault line: tracing impurities in drug manufacturing 2 min reading time Among the numerous potential sources of impurities, changes in the manufacturing of pharmaceutical products are easily overlooked. Replacement of materials in...

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