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Author: Piet Christiaens





September 5, 2025

Use of the Retention Index to Secure Correct Identities in GC/MS

Drug products and medical device extracts are chromatographically analysed via non-targeted analysis to detect, identify, and quantify organic leachables; GC/MS addresses primarily volatile and semi-volatile organic leachables. Identities of compounds detected by GC/MS are often secured by mass spectral matching...

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April 25, 2023

Updated Lab Testing Methods to Safeguard Global Health eBook

This ebook is intended to help educate readers about the importance of rapid, quality testing for extractables and leachables (E&L) to ensure cGMP compliance and, most importantly, patient safety. Inside this ebook you can learn more about trends in the...

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November 24, 2021

Good Identification Practices for Organic Extractables and Leachables Via Mass Spectrometry

The function of a pharmaceutical drug product or a medical device is to provide the patient with a desired therapeutic benefit. If the drug product or the medical device were pure (meaning without impurities), ideally the therapeutic benefit would be...

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July 12, 2021

Good Identification Practices for Organic Extractables and Leachables Via Mass Spectrometry

The function of a pharmaceutical drug product or a medical device is to provide the patient with a desired therapeutic benefit. If the drug product or the medical device were pure (meaning without impurities), ideally the therapeutic benefit would be...

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November 20, 2020

The Necessity of Extractable and Leachable Qualifications for Lyophilized Drug Products: Some Fallacies Addressed

Understand the need to perform extractable and leachable evaluations for lyophilized drug products from a scientific perspective. Lyophilized drug product containers and administration devices consist of the primary packaging (typically a glass vial and a rubber stopper), the reconstitution solution...

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