Watch our webinar recording on YouTube:
“Techniques and Strategies for Non-Target Leachables Analysis in Ointment Drug Products.”
Explore analytical strategies for overcoming the challenges of extractables and leachables testing in complex topical pharmaceutical formulations, including advanced sample preparation techniques, GC-MS analysis, and approaches for detecting and identifying potential leachables.
About this Webinar:
Extractables and leachables (E&L) testing of topical creams and gels presents unique analytical challenges due to complex formulation matrices, potential packaging-related impurities, and low analytical evaluation thresholds (AETs). These pharmaceutical formulations, often consisting of oil-in-water emulsions, require specialized sample preparation techniques to accurately detect and identify potential leachables from packaging components such as tubes and pumps.
In this webinar, explore analytical approaches for overcoming these challenges through advanced sample preparation workflows, gas chromatography-mass spectrometry (GC-MS), and time-of-flight mass spectrometry (TOFMS). The presentation examines two sample preparation methods involving concentration and clean-up techniques designed to reduce matrix interference while achieving the sensitivity required for low-level detection.
Learn how non-targeted GC-MS analysis, combined with TOFMS and mass spectral deconvolution software, can help identify coeluting compounds and improve the detection of potential leachables in complex topical drug products. The webinar also highlights analytical workflows and software tools that support both targeted and non-targeted extractables and leachables analysis.
Gain insights into strategies for addressing matrix complexity, improving analytical sensitivity, and supporting reliable extractables and leachables testing for topical pharmaceutical formulations.
Presenters:
Eric Hill, BA Sciences
Joseph Binkley, LECO
To view the webinar, please click here.