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Determination of heavy metals in drugs

New approval regulations markedly increase the requirements for heavy metals trace analysis in drugs. Instead of the current normal wet chemical limit tests, spectrometric elemental analyses will be mandatory. The ICH Guideline Q3D, whose determinations for new approvals will come into force mid-2016, has other consequences.

UFAG LABORATORIEN AG is one of the leading independent providers of elemental analyses in Switzerland and tests raw materials, auxilliary materials and drugs for heavy metals for its customers.

In the article “Schwermetallen nicht die Spur einer Chance lassen" ("Don’t Give Heavy Metals the Slightest Chance") in the magazine Chemie Plus (Chemistry Plus) 11-2015 you can read about what to look out for with the upcoming legislative changes.

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Schwermetall-Tests nach ICH Guideline Q3D
Heavy metal testing according to ICH Guideline Q3D
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