The new cleanroom at our global headquarters in Salt Lake City, Utah, was designed for today's rigorous contamination control expectations, driven by EU GMP Annex 1. Learn More
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...
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...
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...
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...
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...
