2022 | March / April 2022

Extractable and Leachables in drug products – The toxicological and risk evaluation

by cyb2025

ANTONIO CONTO
Chemsafe, Colleretto Giacosa (TO), Italy

DEFINITIONS
Extractables are chemical substances that can be extracted from the product using aggressive solvent conditions including acidic, basic, organic and aqueous solvent and sohxlet or accelerated solvent extraction. Extractable studies are typically carried out to create a worst-case scenario and support the substances selection and early risk assessment.

ABOUT THE AUTHOR

Antonio Conto is the founder of Chemsafe, an indipendent Regulatory Affairs company established in 2001. He has been working as Experimental Toxicologist in an Italian CRO for 13 years (1988-2001) before founding Chemsafe.
He manages a lot of REACH registration dossiers and related Risk Assessment at international level. In 2011 he was recognized as European Registered Toxicologist i within EUROTOX as well as RENTIC (the Italian Registry of Toxicologist). Antonio pubblished around 100 papers in the field of regulatory science and attended lots of regulatory/scientific events as invited speaker. He is active members of various associations both in the chemical and medical areas (pharma and Medical Devices).

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