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USP <232> Heavy Metals and Dissolution

27th December 2013  the USP general chapter <232> was approved and becomes a requirement, with enforcement in 2015.

Under this chapter, there is a requirement to show that pharmaceutical companies demonstrate that their compounds comply with strict limits for heavy metal and elemental levels determined by the USP. Previous testing for these is acknowledged to have been poor and this change is aimed to correct that anomaly.

In order to demonstrate that, it is necessary that no part of the dissolution system contributes any heavy metals into the system, and in particular the dissolution filters through which samples are taken.

From June1st 2013 all QLA dissolution filters are tested by ICP-MS and certified to be heavy metal free and therefore suitable for dissolution testing.

To further re-enforce the quality of their filters, QLA are introducing their ‘Pure Quality’ label, and all filters labelled as such are traceable not to contain heavy metals.

That coupled with their ISO9001 certification awarded by BSI ensure that QLA product remain at the highest quality level possible.

Customer electing to use non-certified dissolution filters do so at their own risk since not all filters are either good quality or consistent.

Read the USP <232> General Chapter

Read the USP <232> Elemental Impurity Bulletin