Countdown to compliance: Are you ready for the USP <232> and <233> changes?

RSSL will host a free breakfast meeting in Reading, UK on 9 December focusing on the impending changes to the USP <232> and <232>.

The event will be a unique networking opportunity to learn more about analysis of elemental impurities including:

• The latest updates from the ICH and USP;
• Risk assessment – how to decide which elements to look and test for;
• A case study of RSSL’s approach to implementation.

The USP started proposing changes to the <231> heavy metals test in 2008.

USP <231> is a colorimetric method which is not specific and does not provide suitable recovery of the elements being tested. The changes being proposed are necessary as the current <231> and the methodology are out of date.

The new proposal is for the use of inductively coupled plasma optical emission spectroscopy (ICP-OES) and inductively coupled plasma mass spectrometry (ICP-MS) to detect elemental impurities, e.g. heavy metal contamination, wear metals and catalytic residues in drug products, APIs and excipients. The testing methods described in the new chapter <233> are more accurate and sensitive allowing quantitative detection of the elements of interest at ppm levels and lower. While the changes have been postponed, it is intended that USP, EP and ICH methods be harmonised.

On 9 December, RSSL will hold this briefing session to share its knowledge and expertise in elemental impurities analysis from preparation through to analysis by ICP-OES and ICP-MS.

RSSL is a global leader in analysis, research, technical support and training for the pharmaceutical, biopharmaceutical and healthcare sectors.