Extractables and Leachables Analysis

Extractables and leachables (E&L) analysis is an area of growing regulatory significance. It poses a series of challenges to the development of pharmaceuticals, biopharmaceuticals, and medical devices. 

E&L concerns compounds that migrate into a product from container closure systems, manufacturing components, or packaging materials. Devices made from polymeric materials, elastomeric materials, and even metal and glass must also be analysed. These migrating compounds can potentially harm the patient, so regulation is in place to keep this minimal. 

The terms extractable and leachable provide clarity for: 

a) The potential versus the actual impact of the product:

  • Extractable = potential impact
  • Leachable = actual impact

b) The object on which the testing is performed:

  • Extractable = test the component/packaging system
  • Leachable = test the final product/device

Studies begin with a risk assessment to ascertain whether there are any materials that need to be qualified. From here, testing commences across single or multiple stages involving testing on extractables and/or leachables.

The primary end point of an extractable study is the selection or potential de-selection of a material

Do you need E&L testing?

Extractables and leachables (E&L) testing is conducted on a variety of products and medical devices intended for human use. Given the human element, it’s essential to ensure user safety and to stay on top of regulation. Through several chromatographic and spectrometric techniques, analytical science has become central in the medical industry, namely:

  • Orally inhaled & nasal drug products 
  • Parenteral drug products
  • Transdermal Ointments and patches
  • Single-use manufacturing components and systems 
  • Medical devices

Many medical devices and non-solid oral pharmaceutical product require extractable and leachable testing.

Regulatory bodies — such as the FDA and EMA — have provided extensive guidelines for what is expected of manufacturers. Understanding and following these guidelines is essential to avoid costly regulatory delays.

The E&L Process

Assess Risk



Target Leachables

Assess Risk: Review all materials involved in the study in order to define the scope. This is basically the planning stage.

Ascertain Extractables: Use appropriate solvents to extract compounds that could potentially be leachables. This study is performed using laboratory conditions to characterise the materials.

Toxicology: What is the risk to the patient from the potential leachables produced through extractable and leachable studies?

Leachables: Once potential harmful leachables have been ascertained, they can be quantitated in the final product to determine the actual risk that they pose.


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