Elemental Impurity Analysis

Butterworth Laboratories Ltd has been providing contract elemental analysis for nearly 40 years.

We use ICP-OES, ICP-MS and ICP-MS-MS to accommodate the increasing demand for elemental impurity analysis, as a result of the publication of the ICH Q3D guidelines and the resulting changes to the EP, USP and JP.

We have assisted both pharmaceutical and excipient manufacturers with screening of excipients, API and drug products to provide data in support of risk assessments. These assessments are now a requirement in the EU for any marketing authorisation applications for new pharmaceutical products or new products containing an established active substance.

Where the risk assessment has identified possible elements of concern, we can provide method development and validation of material specific procedures for ongoing monitoring.

To find out more please download our White Paper here

To request a quotation please use our contact form

Related Techniques

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QC Testing

Method Development & Validation

GLP Studies

GCP Analysis

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