Supports clients in response to new FDA heavy metal regulations
As the pharmaceutical industry faces the tightest ever new heavy metal mandates from the US FDA, which stipulate the control and documentation, where appropriate, of all elemental impurities in drug products, drug substances and excipients, Almac has invested in ICP-MS equipment at its European headquarters in Craigavon, UK with the aim of satisfying these requirements.
In compliance with USP <232 & 233>, EP (2.4.20), and ICH Q3D, all components, processes, packaging and final product must be tested for the presence of heavy metals, and Almac says inductively coupled plasma mass spectrometry (ICP-MS) is the most suitable technique to meet the requirements of these, and future mandates.
To prepare for these regulations, Almac has built on its mass spectrometry capabilities by investing in Agilent 7900 ICP-MS and Mars microwave digestion technology. This ICP-MS instrument offers exceptional matrix tolerance and unmatched interference and false positives removal with a He collision cell, the company says. It includes Ultra High Matrix Introduction (UHMI) technology that enables routine measurement of samples containing up to 25% total dissolved solids (TDS), which is 100 times higher than the traditional matrix limit for ICP-MS. The high organic kit allows the introduction of samples dissolved in pure solvent, which previously required microwave digestion.
'These mandates dictate a significant shift in the attitude of the FDA towards heavy metals in all aspects of drug development. Customer focus is our top priority, and the enhanced services offered from this additional investment will provide assurance for our clients while complying with the regulatory guidelines,' said Linda McCausland, Head of Almac’s Physical Sciences and Spectroscopy.
The addition of this new instrument complements Almac’s current suite of LC-MS and GC-MS technologies, which were part of a recent US$2m investment in its analytical laboratories.