Preventing Drug Contamination: Extractable & Leachable (E&L)Testing & TRA

Introduction

In the pharmaceutical and medical device industries, patient safety and product integrity are non-negotiable. Extractable and Leachable (E&L) testing is essential for evaluating potential chemical contaminants that may migrate from packaging materials, container-closure systems, or manufacturing components into drug products.

Accuprec Research Labs Pvt. Ltd. offers comprehensive E&L testing and Toxicological Risk Assessment (TRA) services to ensure product safety, compliance, and global market readiness.

Understanding Extractables & Leachables

Extractables are compounds that can be extracted from a material under extreme laboratory conditions, whereas Leachables are compounds that actually migrate into the product during normal usage or storage. Both can pose toxicological or stability risks to the final product.

Why E&L Testing Matters

• Ensures product safety and prevents patient exposure to harmful chemicals
• Supports compliance with regulatory agencies like FDA, EMA, and USP
• Validates packaging compatibility with drug formulations

Accuprec’s Capabilities

Accuprec’s E&L testing laboratory is equipped with state-of-the-art analytical technologies and experienced scientists specializing in comprehensive analysis of drug-packaging interactions and extractables. Our expertise includes:

• Analytical Techniques: LC-MS/MS, GC-MS/MS, ICP-MS, FTIR
• Simulation Studies: Accelerated extraction and migration tests
• Material Characterization: Polymers, elastomers, coatings, and adhesives
• Toxicological Risk Assessment: Evaluating human exposure limits and safety thresholds

Regulatory Expertise

Our E&L testing is conducted in alignment with international regulatory guidelines, including:

• USP <1663> and <1664>
• EMA and FDA E&L frameworks
• ISO 10993 standards for medical devices

Meet Us at CPHI Frankfurt 2025

Connect with our experts at Stall D96 | Hall 6.1 at Messe Frankfurt, Germany, and explore how our Extractable & Leachable Testing and TRA solutions ensure drug purity and global compliance.