Accredited to ISO 17025 standards, WMINOLAB operates as a trusted global partner in the Extractables Leachables studies, leveraging its team of experts and state-of-the-art instrumentation

The primary objective of Extractables and Leachables (EL) studies is to ensure that pharmaceutical packaging is safe and does not negatively impact the drug product.

Impurities that may migrate from pharmaceutical container-closure systems, manufacturing equipment, or medical device packaging into the drug product during production or throughout its shelf life can lead to significant quality issues. Identifying, measuring, and evaluating these impurities—critical risk factors for patient safety—is of utmost importance.

Including EL study data—conducted in reliable laboratories that meet high-quality standards—in national and international regulatory submissions for APIs, finished products, packaging materials, and medical devices is essential for ensuring the safe manufacture of pharmaceutical products.

As WMINOLAB, we perform Extractables and Leachables studies in accordance with global standards, providing comprehensive characterization to ensure the quality and safety of your products.

Acquiring a Chemical Profile for the Risk Assessment

Defining the Material

Obtaining the Accurate Data

Researching Matching with the Databases

Current Literature Research

Characterization and Determination of the Structure

Qualitative

Obtaining the extraction design
Packaging extraction
Determining the extractables profile

Quantitative

Sample screening
Determination of representative quantity with the analytical evaluation threshold approach

Method Validation

Targeted analysis
Quantification
Validation of analytical methods or verification of validated methods

R Studies