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Final ICH Guide Corrects Exposure Limit For Inhaled Cadmium

 
• By Vibha Sharma

An international guideline that sets permitted daily exposure limits for elemental impurities in new drugs has been updated to address an error in the original text regarding the exposure limit for cadmium through the inhalation route.

periodic table
The Revised ICH Guide Set A New Exposure Limit For Inhaled Cadmium • Source: Shutterstock

The International Council for Harmonisation's guideline on the control of elemental impurities in new drug products – which was recently revised to include an updated permitted daily exposure (PDE) limit for cadmium inhalation – has been finalized and is ready for implementation.

The ICH Q3D (R1) guideline establishes PDEs for 24 elemental impurities for drug products administered by the oral, parenteral and inhalation routes of administration. In May 2018, the ICH...

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