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Packaging Extractables Testing in the Pharmaceutical Industry: Migration Detection and Risk Assessment
Pharmaceutical packaging must protect drug products physically and chemically. Extractables testing identifies chemicals that may migrate from packaging into drugs, ensuring safety and regulatory compliance.
What Are Extractables?
Extractables are chemicals released from packaging materials (plastics, rubbers, adhesives) under stress conditions like heat or solvents. Common extractables include:
Plasticizers
Antioxidants
Lubricants
Stabilizers
Residual monomers
They can migrate into drug products from containers such as vials, syringes, and blister packs.
Purpose of Extractables Testing
Identify potential migrating compounds
Establish a worst-case profile for leachables
Support material selection and supplier qualification
Comply with FDA, EMA, USP guidelines
Migration Detection Methods
Solvent Extraction: Simulates harsh conditions to release extractables.
Chromatography (GC-MS, LC-MS): Detects and quantifies organic compounds.
Elemental Analysis (ICP-MS): Identifies heavy metals and inorganic substances.
Spectroscopy (FTIR, UV-Vis): Analyzes functional groups and pigments.
Risk Assessment Strategy
Toxicological Evaluation: Compare detected substances with safety limits like PDE and TTC.
Leachables Simulation: Assess actual migration during product storage.
Material Compatibility: Choose safer materials or apply protective barriers if needed.
Regulatory Guidelines
USP <1663> & <1664>: Extractables and leachables testing standards.
ICH Q3D: Elemental impurities guidelines.
FDA Guidance: Packaging system requirements for drugs and biologics.
Pharmaceutical companies must demonstrate packaging safety to protect product quality and patient health.
Conclusion
Extractables testing is vital for safe pharmaceutical packaging. Using validated analytical techniques and thorough risk assessment ensures compliance and patient safety, supporting product integrity from manufacturing to use.
