ARDL offers comprehensive support for extractables and leachables studies, with years of experience in identifying and quantifying organic and inorganic components in a wide variety of products, including: polymers, plastics, metals, pharmaceuticals and other matrices.

Extractables are chemical species that migrate from a product or packaging component under aggressive exposure or storage conditions such as high temperature, long duration or contact with solvents.

Leachables are chemical species that migrate from a product or packaging component under normal conditions of exposure or storage.

Techniques
Analytical techniques involved in extractables and leachables studies include:
     • Gravimetric and Colormetric Analysis
     • Inorganic Species by ICP-OES and Cold Vapor AA
     • Organic Species by GC, GC/MS, HPLC, LC/MS
     • pH
     • Spectroscopy (UV/VIS, FTIR)
     • Total Organic Carbon (TOC)

Click here for available Extractables and Leachables methods

Good Manufacturing Practices
21CFR211.94(a)(b)

• Drug product container and closures shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality or purity beyond the official or established requirements.

• Container closure systems shall provide adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination of the drug product.