Identifying impurities

Identifying impurities is the first step in preventing them. By elucidating the structure of impurities, it is possible to understand their formation mechanism, which can then inform industry practice around prevention or control.

For impurity identification, the components of the drug must be separated to isolate any process contaminants, degradants, or leachables alongside the active pharmaceutical ingredients (APIs).

This can be achieved using high-performance liquid chromatography-mass spectrometry (LC-MS), which provides mass information for less volatile impurities, enabling structural identification. For more volatile impurities, gas chromatography-mass spectrometry (GC-MS) is required. Following separation, nuclear magnetic resonance (NMR) spectroscopy and Fourier-transform infrared (FTIR) spectroscopy can be used to identify any impurities in the sample.

Different combinations of techniques are used on a case-by-case basis, considering the complexity of the compound and the purity requirements of the customer. ISP Standards has state-of-the-art instrumentation and highly qualified teams to ensure the highest standards throughout impurity analysis, in addition to its catalogue of fully compliant impurity standards.