Warwick Analytical Services has launched the ICP Analytical Service to enable pharmaceutical manufacturers to analyse and report metal impurities under standards proposed by the US Pharmacopeia (USP).
The current USP standard method (231) for determining 'heavy metals' in pharmaceutical ingredients and products involves precipitating metal sulphides out of an aqueous solution, then visually comparing the colour of the test sample with that of a standard lead solution.
Although still widely accepted and used in the pharmaceutical industry, these methods, which are based on the intensity of the colour of sulphide precipitation, are increasingly viewed to be non-specific, insensitive, time consuming and labour intensive and do not provide an adequate recovery of the elements being tested.
As a result of these limitations, the USP has proposed to replace the USP 231 heavy-metals test with a method using inductively coupled plasma emission spectroscopy (ICP).
The new ICP method will test for Al, Sb, As, Be, B, Cd, Cr, Co, Cu, In, Ir, Fe, Pb, Li, Mg, Mn, Hg, Mo, Ni, Os, Pd, Pt, Rh, Rb, Ru, Se, Sr, Tl, Sn, W and Zn.
The proposed revision will eliminate the specificity issue, provide greater sensitivity down to part-per-billion (ppb) levels and evaluate the drug sample for an additional 21 elements.
Operating in an ISO 17025- and GMP-compliant environment, following strict operating procedures, ensures that Warwick Analytical Service consistently delivers good-quality ICP data.
Equipped with modern high-resolution ICP instrumentation, the company is able to resolve complex spectra and analyse difficult samples.
Routine detection limits are low for most elements (typically less than 10ppb) and multi-element determinations can be achieved rapidly and precisely.
