With the USFDA and the European Medicines Agency turning their attention more and more to pharma packaging material, we look at three different phases of studies that can help alleviate the risk of extractable and leachable chemical components being released.

Prior to the release of a pharmaceutical, it has always been necessary to determine the impurity profile of the final product, however nowadays the impurities from the components used during manufacture and storage must be also considered. Consequently, Extractable & Leachable studies have become critical in determining the interactions between manufacturing components and product.

By definition, Extractables are the chemicals that can be extracted from the packaging under aggressive conditions (organic solvents, acidic and basic aqueous solvents and/or exaggerated temperatures and pH values); while Leachables are those released into the product under normal use and shelf-storage. 

Defined in three stages, such studies usually comprise of:

1/ Extractables Study

  • The output of this study is a fully comprehensive profile of substances (organic and inorganic) extractable from the material.  To achieve this, very strong conditions (aggressive solvents and/or high temperature) are usually selected for the extraction.  
  • Making use of analytical expertise, individual extracts are analyzed via different techniques, such as HS-GC-MS (for volatile organic compounds), GC-MS, LC-UV-MS (for non-volatile organic compounds), ICP-MS (for elemental impurities), or IC-CD (for inorganic anions).
  • The results are compared with a database containing the most common organic extractables, and unknown substances are further identified by mass spectrum. 
  • Following the identification, a quantitative determination follows. 

 

2/ Method development and toxicological assessment

  • Those Extractable substances that could be released during the normal use of a specific product, in other words, the Leachables, are identified. A toxicological assessment for individual Leachable is then carried out.
  • Analytical methods for the measurement of Leachables are developed and validated by our scientists. 
  • In strict agreement with the ICH Q1A directive, the conditions for the Leachables study are set, reflecting the intended use and storage time of the product.

3/ Leachables study

  • Stressed samples are subsequently tested and then analyzed by multiple validated methods.

As a world-leading pharma service provider who offers a wide range of pharmaceutical analyses under Good Manufacture Practice, QUINTA-ANALYTICA are experts in providing such comprehensive Extractable & Leachable studies.  

Considering that authorities are now taking a closer and closer look at the packaging as well as the drug, it’s not worth taking the risk. Get in touch with the Quinta team to plan your next study and a huge stride forward in your drug development today.

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