RSSL supports companies with method development and validation

Published: 9-Apr-2014

Calorimetric heavy metal tests in USP <231> will be replaced in December 2015

With the impending radical changes to the USP heavy metals tests Reading Scientific Services Ltd (RSSL) is focusing on supporting companies with method development and validation.

December 2015 will see withdrawal of the century-old calorimetric heavy metals tests in USP <231> and replacement of the same with the spectroscopy methods contained in the new elemental impurities chapters USP <232> and <233>, meaning there is an urgent requirement for businesses to implement new testing regimes, although some are waiting for the outcome of ICH Q3D before doing so.

There are many reasons why metals testing is crucial in the pharmaceutical industry. When metal catalysts (platinum, palladium etc.) are used in the production processes of pharmaceutical APIs it is imperative that no traces of these toxic metals remain in the finished products. Similarly if particular metal salts are used in cleaning processes no residues should remain. Toxic heavy metals (e.g. arsenic, cadmium, lead and mercury) are ubiquitous in the environment and detectable levels are therefore present in some raw materials. In formulations where metal salts are present, assay testing should be conducted to confirm that appropriate levels are present.

Of course, not all testing is affected by or falls under the scope of the USP chapters and RSSL has supported companies with atomic spectroscopy methods for metals analysis for many years.

Calum McOmish, Metals Laboratory Manager at RSSL, said: 'RSSL’s state-of-the-art analytical instrumentation and preparation techniques mean that we are extremely well equipped to develop and validate fit-for-purpose metals methods in pharmaceutical matrices. Using techniques including ICP-MS and ICP-OES, we work with clients in areas such as heavy metal limit tests, elemental assays, catalyst residues and cleaning validation and routinely conduct metals methods verifications and transfers.'

You may also like