Element follows a risk-based assessment approach to help you develop extractables and leachables (E&L) testing protocols tailored to your specific needs that meet the E&L best practices and industry regulations. 

As the best practices for pharmaceutical extractables and leachables testing are not mandated or prescriptive in their nature, the final design and protocol development is ultimately left to the pharmaceutical company to be determined. For example, there is no standard protocol for the selection of solvents and conditions of contact. 

At Element, we understand the regulatory expectations for each type of drug product and, working closely with you; we help you to develop the most efficient testing protocols that meet the risk-based approach for these products.

Our approach to custom extractables and leachables study protocols

We apply the following phases to the various products:

  • Materials risk assessment
  • Controlled extraction study
  • Simulation extraction study
  • Toxicological assessments
  • Peak identification both primary & secondary structural elucidation
  • Method development for target leachables
  • Method validation for target leachables
  • Routine leachables testing

Some of the available choices in protocol development include:

  • Which components should be tested?
  • Should the components be tested separately or grouped together?
  • What solvents should be selected? How many?
  • What are the “worst case” extraction conditions (time and temperature)?
  • What extraction techniques should be utilized?
  • How many sampling points?
  • Which extractables methods should be validated as leachables methods?
  • Which targets should be selected for the leachables validation?
  • Should an accelerated leachables study be used?

Our Engaged Experts can answer these questions by reviewing the type of drug product, route of administration, the composition of the packaging and manufacturing equipment used. When formulating your customized testing protocol, we also take into consideration the budget and timelines for the regulatory submission.  

For more information about how we streamline extractables and leachables testing protocols or to request a quote, contact us today. 

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