All components, processes, packaging and final product must be tested for the presence of heavy metals to be in compliance with USP <232 & 233>, EP (2.4.20), and ICH Q3D. According to the company, inductively coupled plasma mass spectrometry (ICP-MS) is the most suitable technique to meet requirements of these, and future regulatory requirements.
Almac has invested in Agilent’s 7900 ICP-MS and Mars microwave digestion technology that offers exceptional matrix tolerance, interference, and false positives removal with a He collision cell, according to the company. It includes Ultra High Matrix Introduction (UHMI) technology that enables routine measurement of samples containing as much as 25% total dissolved solids (TDS). Also, the high organic kit allows the introduction of samples dissolved in pure solvent, samples, that previously required microwave digestion.
Linda McCausland, head of Almac’s Physical Sciences and Spectroscopy said, “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 whilst complying with the regulatory guidelines.”
Agilent Technologies was selected as the preferred vendor to supply the Mass Spectrometers to Almac. Declan Murray, sales manager said, “Agilent is delighted that Almac has invested in the industry leading Agilent 7900 ICP-MS. Agilent has a long and successful relationship with Almac and we’re looking forward to working with their analytical team to strengthen this relationship even further.”