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Author: Piet Christiaens





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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May 26, 2020

Why Extractables and Leachables Matter

Medicines and other healthcare products rely for their value, integrity and commercial longevity on a delicate balance between quality, safety and efficacy. When that balance is disturbed by issues such as product adulteration, the damage to patients, revenues and corporate...

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