Subathra Ramamoorthy on extractables and leachables in bioanalysis: key insights and best practices

Drug development Interviews Regulated bioanalysis Toxicology

During the American Association of Pharmaceutical Scientists (AAPS) PharmSci 360 2025 conference, Bioanalysis Zone caught up with industry experts across numerous disciplines to discuss their involvement with AAPS and their research. In this interview, we spoke to Subathra Ramamoorthy about key bioanalytical insights and best practices in extractables and leachables (E&L) studies.

Disclaimer: The opinions expressed in this interview are those of the author and do not necessarily reflect the views of Bioanalysis Zone or Taylor & Francis Group.

Interview questions:

  1. For those new or unfamiliar to the field, can you explain what extractables and leachables (E&L) actually are in simple terms? Why should we care about them?
  2. Could you walk us through the most important factors to consider when designing robust E&L studies?
  3. Can you explain how analytical evaluation threshold (AET), safety concern threshold (SCT) and threshold of toxicological concern (TTC) work together in practice? How do these thresholds guide decision-making?
  4. What happens when analytical results fall between these different threshold levels? How do you address that gray area?
  5. When FDA, EMA, USP and ISO guidance conflicts on E&L testing, how do you advise companies to navigate these differences?
  6. How do you decide which analytical platform (LC-MS, GC-MS, or ICP-MS) is most appropriate for a given E&L study?
  7. As we wrap up, what’s one thing you hope listeners will remember most from our conversation today?

 

Meet the speaker

Subathra Ramamoorthy
Senior Scientist
Veranova (MA, USA)

Subathra Ramamoorthy, MS, RPh, is an Associate Principal Scientist at Veranova with extensive experience in pharmaceutical analytical development. Her work spans method development, impurity profiling, extractables and leachables, and regulatory compliance for complex APIs and finished products. She has expertise in navigating science with compliance, chromatographic and spectrometric techniques including HPLC, LC–MS, GC–MS and ICP–MS, and has led risk assessments for nitrosamines, elemental impurities and genotoxic contaminants. Subathra actively contributes to scientific forums and publications and is a board-certified pharmacist. Her interest in advancing analytical science includes exploring the integration of emerging platforms like SEC–MALS to enhance data quality, workflow efficiency and regulatory robustness.

About AAPS

American Association of Pharmaceutical Scientists (AAPS) is a non-profit association of more than 7000 scientists and professionals employed in academia, industry, regulatory and other research related to the pharmaceutical sciences worldwide. Its mission is to advance the capacity of pharmaceutical scientists to develop products and therapies that improve global health, which members pursue through four peer-reviewed journals and a variety of events in person and online.

AAPS PharmSci 360 delivers research from across the pharmaceutical continuum, from discovery to delivery, and all stages in between. Thousands of scientists from across the globe converge to discuss cutting-edge breakthroughs, technologies, and techniques in symposia and poster presentations at this science-first event. https://www.aaps.org/pharmsci360.