Ahead of this year's Extractables & Leachables Asia, we spoke with Prabhakar Reddy, Ph.D, Director of Pharmaceutical Sciences General Chapters & Complex Generics at USP, who will be co-presenting with Ravi Kiran Kaja, Ph.D, Senior Principal Scientist at USP, to get a sneak peek of their presentation, “Updates on the Finalized System Suitability Standards Proposal from USP for the analysis of Organic Extractables & Leachables.” Here's what they had to say…


Q1. Why is this message particularly critical for industry professionals to hear right now?

Currently, there are no compendial or regulatory system suitability standards specifically designed for Extractables and Leachables (E&L) screening studies. This gap has led to inconsistencies in data quality, method performance, and regulatory compliance across laboratories worldwide. Given the complexity of analytical platforms like GC-MS and LC-MS, ensuring that instruments are functioning optimally before screening is essential. Without standardized system suitability checks, critical compounds may go undetected—posing potential safety risks to patients.

Recognizing this need, USP initiated a global effort in 2021 to develop robust, scientifically justified system suitability standards. This initiative was strongly supported by stakeholders through multiple surveys and culminated in a comprehensive round robin study involving 15+ global labs. The finalized set of standards now includes chemically diverse mixtures tailored for key analytical methods (Direct and Headspace GC-MS, LC-MS with ESI and APCI), with compounds selected to assess sensitivity, specificity, linearity, and chromatographic performance.

This message is especially timely as USP prepares to publish a second stimuli article and considers integrating these standards into General Chapter <1663>. For industry professionals, adopting these standards will not only enhance confidence in E&L data but also support global harmonization, regulatory acceptance, and ultimately, patient safety.


Q2. With evolving guidelines like USP <1663> and ICH Q3E, how do you foresee the regulatory landscape for E&L testing changing in the short future?

The regulatory landscape for E&L testing is on the cusp of significant transformation. While ICH Q3E is still under development, its eventual release is expected to bring global alignment and clarity to extractables and leachables testing and reporting, especially for complex drug products and delivery systems. In parallel, USP has proactively engaged the global scientific community through a comprehensive stakeholder survey to evaluate the relevance and scope of its current chapters, <1663> and <1664>. The feedback was clear: there is a strong demand to modernize these chapters to reflect recent scientific advances and to broaden their applicability to emerging modalities and complex materials.

In response, USP plans to initiate a major revision of these chapters starting in early 2026, following the formation of a new expert committee as part of the next revision cycle. These updates are expected to integrate new system suitability standards, address complex product categories, and align more closely with evolving international expectations.

In short, we are entering a pivotal era where harmonized, science-driven standards will elevate consistency, reliability, and regulatory confidence in E&L testing worldwide.


Q3. In resource-limited settings, how can companies prioritize E&L testing without compromising compliance?

In environments where resources are constrained, maintaining compliance with E&L testing can be particularly challenging, but not impossible. USP’s proposed system suitability standards are designed to be practical, reproducible, and globally applicable, helping laboratories of all sizes ensure their analytical systems are functioning correctly before screening begins. These standards offer a cost-effective way to verify method performance without the need for extensive in-house development.

Moreover, USP is expanding its suite of General Chapters to include targeted guidance for leachable assessments across a range of dosage forms—including oral, ophthalmic, parenteral, topical, and transdermal products. These upcoming chapters, along with associated analytical reference materials (ARMs), will provide scientifically validated tools and methods that can streamline testing and reduce the burden on individual labs to develop their own protocols from scratch.

By leveraging USP’s standardized tools and evolving guidance, even resource-limited labs can uphold high standards of quality and compliance—ensuring patient safety without overextending operational capacity.


Q4. How does the shift toward sustainable/biodegradable packaging materials complicate E&L profiling?

The transition to sustainable and biodegradable packaging materials introduces a new layer of complexity to extractables and leachables (E&L) profiling. While adoption in the pharmaceutical and biopharmaceutical sectors is still limited, the momentum is growing driven by environmental responsibility and regulatory encouragement. However, these novel materials often have less well-characterized chemical compositions and degradation pathways compared to traditional polymers.

This lack of historical data and standardized testing protocols makes it challenging to predict and assess potential leachables, especially under various storage and stress conditions. As these materials become more prevalent, the industry will need to develop new analytical strategies and expand existing guidance to ensure patient safety is not compromised.

In essence, the push for sustainability must be matched with scientific rigor—requiring proactive research, method development, and regulatory collaboration to ensure that greener packaging doesn’t come at the cost of product integrity or patient safety.


Q5. If you could propose one industry-wide initiative to tackle E&L challenges, what would it be?

If there were one initiative to unify and elevate the industry’s approach to E&L testing, it would be the global adoption of standardized system suitability protocols for extractables and leachables analysis. The greatest challenge facing the pharmaceutical and biotech sectors today is the generation of consistent, reproducible, and scientifically defensible E&L data across diverse labs, instruments, and methodologies.

Recognizing this, USP has invested over four years—guided by extensive stakeholder engagement and rigorous scientific evaluation—to develop comprehensive system suitability standards for GC-MS and LC-MS methods. This initiative is not just about instrument suitability,  it’s about building a foundation of trust in the data that drives regulatory decisions and protects patient safety.

A harmonized, industry-wide commitment to system suitability would transform E&L testing from a fragmented practice into a globally aligned, quality-driven discipline—ensuring that no matter where or how testing is performed, the results are reliable, reproducible, and regulatory-ready.