Purpose and Importance

In the pharmaceutical industry, product safety extends beyond the active ingredients — it also depends on the compatibility of packaging materials and delivery systems with the drug formulation.

Extractable & Leachable (E&L) Testing and Toxicological Risk Assessment (TRA) are essential studies to ensure that packaging components such as bottles, vials, rubber stoppers, or pre-filled syringes do not release harmful substances into the medicine over time.

During manufacturing, storage, or distribution, certain chemical substances may migrate from packaging materials into the drug product. These contaminants can impact the safety, efficacy, and stability of the drug. Regulatory agencies like the FDA, EMA, and ICH mandate E&L studies to ensure that no harmful interaction occurs between the container and its contents.

Conducting TRA alongside E&L testing helps evaluate the potential toxicological effects of any detected impurities, supporting risk-based safety decisions.

Our Testing Approach

At Accuprec Research Labs Pvt. Ltd., we provide a complete E&L testing solution designed to meet global regulatory guidelines. Our approach includes:

• Material Characterization: Identifying and analyzing packaging materials such as plastics, rubbers, glass, and metals.
• Extraction Studies: Using advanced techniques like GC-MS, LC-MS/MS, and ICP-MS to detect and quantify extractable compounds under controlled conditions.
• Leachable Studies: Simulating real-time storage conditions to determine which compounds actually migrate into the product.
• Toxicological Risk Assessment (TRA): Evaluating toxicological data to assess health risks and determine safe exposure limits.

Why Choose Accuprec

• Advanced Instrumentation: Equipped with state-of-the-art analytical tools for precise detection at trace levels.
• Expert Team: Experienced toxicologists and analytical chemists ensure scientifically sound, regulatory-compliant results.
• Comprehensive Reporting: Audit-ready reports to support regulatory submissions and product approvals.
• Global Compliance: Studies conducted following ISO 17025, OECD-GLP, USFDA, and EMA standards.

Outcome

Our E&L and TRA studies help pharmaceutical manufacturers ensure product integrity, minimize regulatory risks, and guarantee patient safety. By partnering with Accuprec, you gain confidence that your packaging materials and delivery systems meet the highest international quality standards.