Warwick Analytical Services (WAS) rolls out Inductively Coupled Plasma Emission Spectroscopy (ICP) service to help drugmakers determine heavy metals in pharmaceutical products.
The new ICP method, which will allow pharmaceutical manufacturers to analyse and report metal impurities, is regulated under new rules set out by the US Pharmacopeia and will differ from the current USP method for distinguishing ‘heavy metals’ in pharmaceutical ingredients and products, say WAS.
The current USP method involves precipitating metal sulphides out of an aqueous solution, then comparing the colour of the test sample to that of the original solution. WAS say this method is “non-specific, insensitive, time-consuming and labour intensive, and it does not provide an adequate recovery of the elements being tested.”
The analytical services company, based at the University of Warwick Science Park, in the UK, claims the new ICP method is more sensitive due to part-per-billion (ppb) levels, will eliminate the specificity issue, and is able to evaluate a drug sample for 21 additional elements.