The Edinburgh pharmaceutical lab of the global testing group Exova has added a new ICP-MS testing capability that will allow it to provide specialist trace metal analysis from a UK base for the first time
Inductively-coupled plasma mass spectrometry (ICP-MS) is the process of measuring trace metals in pharmaceuticals and raw materials, including proteins and peptides. The new capability has added importance due to new regulations monitoring heavy metals in raw materials, some of which come into force later this year.
The regulations state that all raw materials must undergo quantitative trace and heavy metals analysis, a type of specialist testing which is best carried out by ICP-MS.Mark Benger, general manager, for Exova’s Edinburgh lab, said: “This highly specialised service is a growth area for Exova. Indeed, our US colleagues have been recognised world experts in ICP-MS for the past 20 years.”
“With the regulations for heavy metals in raw materials changing this year in the EU and next year in the US, we wanted to demonstrate our expertise and further cement our global reputation in the fields of testing and analysis.
“It marks an exciting new capability for our UK operation and underpins Exova’s commitment to providing our customers with the confidence and assurance they require.”
The Agilent 7700 and Ultrawave microwave digester will be a key tool in helping Exova’s customers guarantee compliance with ICHQ3D regulations, and in accordance with USP chapters <232> & <233> and also EP chapters 2.4.20 and 5.20 in accordance with ICHQ3D.
Exova’s Edinburgh Pharma facility has been operational since 1988, and primarily serves the pharmaceutical, biotech and medical device markets. It is a GMP pharmaceutical laboratory and has been audited and approved by the MHRA for chemistry and microbiology analysis on pharmaceutical products and their components.
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