Shiva Analyticals Navigating the New Regulatory Era
The pharmaceutical industry is witnessing a pivotal shift in how we assess Extractables and Leachables (E&L)—driven by the newly released ICH Q3E guideline (August 2025) and evolving USP recommendations. These updates emphasize a risk-based, science-driven approach to evaluating materials that interact with drug products, especially in complex delivery systems.
As regulatory expectations evolve, so must our analytical strategies. The recent release of ICH Q3E marks a significant milestone in harmonizing global approaches to Extractables and Leachables (E&L) assessments. This guideline emphasizes a science- and risk-based framework for evaluating materials that come into contact with pharmaceutical products—especially critical for complex drug delivery systems, biologics, and combination products.
What Are Extractables and Leachables?
Extractables are chemical compounds that can be released from packaging or device materials when exposed to harsh laboratory conditions, simulating worst-case scenarios. Their identification helps anticipate potential risks and informs leachables study design.
Leachables are compounds that migrate into the drug product under normal storage or use conditions. Since they represent actual patient exposure, their detection and evaluation are critical for ensuring product safety and meeting regulatory requirements.
At Shiva Analyticals (India) Private Limited, we’ve built a comprehensive E&L platform that integrates cutting-edge instrumentation with deep regulatory insight. Our capabilities span the full spectrum of volatile, semi-volatile, non-volatile, and elemental impurity analysis.
Our Analytical Arsenal for E&L Studies
|
Analyte Class |
Technique |
Instrumentation |
Application |
|
Volatile & Semi-Volatile |
GC-MS |
Agilent 8000 Series |
Detection of residual solvents, plasticizers, and degradation products |
|
Non-Volatile Organics |
LC-MS/MS |
Sciex 6500, Sciex 5500, Waters TQS-micro |
Identification and quantification of oligomers, antioxidants, and additives |
|
Elemental Impurities |
ICP-MS |
Agilent 7700 Series |
Quantification of Class 1–3 elemental impurities per ICH Q3D / USP / |
Regulatory Landscape
- ICH Q3E (2025): Introduces a lifecycle-based, risk-driven approach to E&L assessments, emphasizing toxicological relevance and analytical justification.
- USP <1663>/<1664>: Provides guidance on extractables profiling and leachables simulation studies.
- ICH Q3D / USP <232>/<233>: Governs elemental impurity limits and risk assessments for drug products
Our End-to-End E&L Services
- Controlled Extraction Studies: Simulating worst-case scenarios using aggressive solvents and elevated conditions
- Leachables Simulation: Real-time and accelerated studies tailored to product-specific storage and usage conditions
- Analytical Data Packages: Generation of high-quality, traceable data suitable for toxicological interpretation and regulatory review
- Collaborative Support: Partnering with clients and third-party toxicologists or regulatory consultants for downstream risk assessment and submission needs
- Lifecycle Testing: Ongoing E&L monitoring to support packaging changes, stability studies, and post-approval modifications
Why Partner with Us?
- Regulatory Expertise: Deep understanding of global E&L expectations across US FDA, EMA, PMDA, and WHO
- Analytical Depth: High-sensitivity instrumentation for trace-level detection and quantification
- Integrated Workflow: From study design to toxicological interpretation and submission-ready reports
- Speed & Scalability: Agile turnaround times and scalable capacity for early-phase to commercial programs
Whether you're a CDMO, biotech innovator, or regulatory lead, we’re here to help you navigate the evolving E&L landscape with confidence and clarity.
Let’s connect to building a customized E&L strategy that aligns with your product lifecycle and regulatory goals
With our integrated platform and regulatory foresight, we help pharma and biotech partners de-risk their packaging, delivery systems, and combination products—ensuring patient safety and global compliance.
Let’s collaborate to build a science-driven, risk-based E&L strategy tailored to your product lifecycle.
About Shiva Analyticals
Shiva Analyticals is a leading testing laboratory in India, offering precise analytical services across industries such as pharmaceuticals, food, agriculture, and petroleum. Specializing in regulatory compliance and safety, Shiva uses state-of-the-art facilities and cGMP-compliant practices to deliver reliable, tailored solutions that help businesses ensure product quality and meet industry standards.