Publications

Determination of heavy metals in accordance with emea

Final pharmaceutical products as well as raw materials often contain residues of heavy metals. These have been introduced to the product through a range of chemical processes in the course of the production process.

Until now, the monographs of the pharmacopoeias Ph. Eur. and USP stipulated the testing for heavy metals by means of a limit test. However, this test has a number of disadvantages.

For this reason, the European Medicines Agency (EMEA) has issued a new guideline in 2008: EMEA/CHMP/SWP/4446/2000.

This defines the concentrations in which particular heavy metals may be present. The respective acceptance criterion depends on the classification of the metal and the intended purpose of the pharmaceutical product. These specifications also result in more stringent requirements for the chosen test procedure.

In future, spectroscopic methods such as ICP-OES, FAAS and GAAS will predominate in the determination of heavy metals.
In an article in the Chemischen Rundschau 5/2009, Daniel Frattini of UFAG LABORATORIEN AG examines the context and consequences of replacing the old limit tests.

With reference to the practical implications, he illuminates the impact of the content of the new EMEA guidelines on the concentration limits for the various classes of metals and the analytical methods most appropriate to use.

For enquiries concerning the article, please contact the author by calling our service desk.