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 10 – Yellow Discoloration of a Drug Product – How a Database Similarity Search Reveals the Culprit 3 min reading time A customer contacted us for analytical assistance to find the substance responsible for yellow discoloration of a...
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...
Blogpost 1 – An unexpected impurity in my drug product, what now? 6-7 min reading time Welcome to the first article in a series of blog posts on impurities in drug products. These blog posts will focus on different situations...
To consistently deliver safe and effective pharmaceutical products, processes for impurity control must be established and followed. It is both unfortunate and inconvenient to encounter an unexpected impurity while practicing routine quality control. It requires immediate action to identify, quantify,...