Extractables and Leachables Testing

Extractables and leachables testing, also known as E&L testing, is a form of testing often used in the pharmaceutical and medical device industries. Extractables are compounds that can be extracted from a product under extreme conditions such as high temperatures or the use of solvents. Leachables, on the other hand, are compounds that migrate from a product under normal conditions of use.

The purpose of E&L testing is to identify any potential contaminants that could be released from a product and thus pose a risk to the patient or user. These contaminants may come from the packaging, the manufacturing process, or even the product itself. The testing process involves simulating the conditions under which the product will be used and then analyzing the results to determine the presence of any extractables or leachables.

After the completion of the extractable or extractives test, safety assessment should be conducted on the results according to the type and content of extractable or extractives in the filter, combined with the concentration, dose size, administration time and administration route in the final dosage form of the drug, so as to assess whether the extractable or extractives have safety risks.

STEMart provides comprehensive and reliable extractables and leachables testing services to ensure product safety and effectiveness and compliance with regulatory standards.

Test Samples

Silicone tubes, liquid storage bags, filters, mixing bags, etc.

Standard Tests

• UPLC and HPLC-MS/MS, HPLC Q-Tof (ESI, APCI), HPLC-UV, DADHS-GC, HS-GC-MS, GC-QTof (EI, CI)
• Semi-preparative fraction collection by HPLC
• Accurate mass determination by mass spectrometry
• Peak purity confirmation
• GC (FID, ECD, FID-NP), GC-MS
• GC-TEA (nitrosamines)
• HPLC-MS/MS (ESI) Perfluorinated Acids (PFCA)
• ICP-OES, ICP-MS, AAS, IR
• IC-ED (anionic, cationic)
• FTIR
• Accelerated Solvent Extraction (ASE)
• Soxhlet extraction and reflux extraction
• Static or dynamic liquid extraction by utilizing pump flow methods
• Simulate usage and migration studies

For more information about our extractables and leachables testing services, please contact us.