Regulatory Hot Topics III

Joint Pharmaceutical Analysis Group; Royal Society of Chemistry, London

Malvern Panalytical had pleasure in presenting a poster on USP<232> and ICH Q3D Elemental Impurities Standards for X-Ray Fluorescence Analysis at the Regulatory Hot Topics III, Joint Pharmaceutical Analysis Group at the Royal Society of Chemistry, London.

The symposium addressed the issues and challenges related to the implementation of new and emerging guidelines. It was a fantastic opportunity for the delegates that attended to engage with speakers, the presenters of various posters including Malvern Panalytical as well as the delegates that attended.

Many topics were discussed including of particular interest impurities in new drug substances (ICH Q3A/3) and elemental impurities (ICH Q3D).

Many of the delegates present were very interested in the poster I presented as never before have commercial standards been made available for the measurement of pharmaceutical materials using the analytical technique of X-Ray Fluorescence. These calibration sets were submitted for external testing by an FDA and ISO 17025 accredited laboratory to confirm the expected spiking levels. The data shown was measured on the Epsilon 4 energy dispersive benchtop X-Ray Fluorescence spectrometer.

The value that these calibration standards in combination with the XRF technique to the pharmaceutical sector is as follows:

• Sample preparation is reduced to minutes.
• Analysis is non-destructive, so sample can be further analyzed by other techniques.
• No hazardous solvents required.
• No dilutions required
• Consumable costs reduced by an order of magnitude.
• X-ray tube expected to last the life of the instrument.

Related content:

• Poster – USP<232> and ICH Q3D elemental impurity standards for X-Ray fluorescence analysis
• Webinar –  The simple alternative to ICP-MS for elemental impurity analysis in pharmaceutical products