Piramal Pharma Solutions Blog

Piramal Pharma Solutions Blog

Integrated Solutions for Extractables and Leachables

Posted on Sep 27, 2016 10:02:46 AM by Piramal Pharma Solutions in sterile manufacturing, in extractables and leachables

Studies of extractable and leachable components (E&L) within packaging systems and pharmaceutical container closures have become mandatory to meet the safety requirements for marketed medicines over the past two decades. The regulatory guidance for E&L provides only general recommendations to ensure safety. The development and analysis of E&L for inhalation, ophthalmic, and injectable drug products is challenging since studying them depends on the type of formulation and packaging material being used.

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