Technical / White Paper

Elemental Impurity Analysis in Pharmaceuticals

Published

Format: PDF file | Document type: Technical / White Paper

Butterworth

A method to identify the presence of heavy metals in pharmaceuticals was introduced in the United States Pharmacopoeia more than 100 years ago. Today pharmaceutical companies are still using essentially the same method, the USP <231> Heavy Metals Limit Test. This paper will give an overview of the current method limitations, considerations for the new methodology and the risk-based assessments being carried out by manufacturers.

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