Leachable & Extractable

Extractables are chemical compounds that can be released from packaging material, device components, or manufacturing systems under exaggerated laboratory conditions such as strong solvents or elevated temperatures. These conditions are designed to simulate worst-case scenarios and identify potential leachable substances.

Leachables are chemical compounds that migrate into a drug product or formulation under normal use or storage conditions. They originate from packaging materials, manufacturing equipment, or delivery systems and result from direct contact with the product. Leachables may impact product quality, stability, or safety and are therefore critical to evaluate in safety assessments.

Extractables and Leachables (E&Ls) are considered impurities that may migrate into a drug or product. If not identified, quantified, and controlled, they can affect potency, stability, safety, quality, and overall effectiveness— posing significant risks to consumers and leading to regulatory non-compliance.

E&L assessments are guided by several key standards and guidelines, including ISO 10993 for medical devices, USP General Chapters <1663> and <1664> covering pharmaceutical packaging and delivery systems, and the ICH Q3E guideline for extractables and leachables, which provides a framework for testing and toxicological evaluatio.

SciQra’s expert toxicologists provides Toxicological Risk Assessments (TRA) and Hazard Summaries for Extractables and Leachables (E&Ls). We evaluate health risks, establish safe exposure limits, and deliver regulatory-accepted justifications helping companies meet global compliance while ensuring product safety.