Elemental Impurities Analysis

Alan Cross, RSSL Technical Specialist, Metals Laboratory provides an insight into elemental impurities analysis in an article published in Manufacturing Chemist.

In the May issue of Manufacturing Chemist,  RSSL's Technical Specialist, Metals Laboratory, Alan Cross, provides an insight into Elemental Impurities Analysis. 

The control of elemental impurities has long existed within the US and European pharmacopoeias, but the wet chemistry tests specified in them are beset with several problems.

He covers ICH guidelines, risk assessment, ICH and the pharmacopoeias, method development and validation, concluding that "The road to agreement on elemental impurities regulation has been a long and winding one, but it does seem that there is now a clear view to the final destination. The work of the ICH and the relevant local regulators has led to a final procedure that has made the testing requirement less onerous on the manufacturer. With adequate risk assessment procedures, the process of compliance is much simplified and reduces the reliance on analysis."

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