Benefiting from its vast experience in analytical services, including trace analysis in numerous matrices, Solvias has the experience and capability to provide comprehensive services for investigating leachables and extractables in accordance with the guidelines of the EMEA and FDA for primary packaging materials. A typical program is made up in the following way.

Design and Perform an Extractable Study
Extract packaging material with defined solvents under defined conditions and analyze extract (for example using GC-MS, LC-MS, and for inorganics using ICP-OES, ICP-MS, AAS). If possible, identify the chemical structures.

Perform Risk Assessment
Evaluation of the hazard potential and maximum acceptable limits of each chemical detected by a toxicologist.

Develop Analytical Methods for the Drug Product Matrix
Make sure that all identified critical substances can be analyzed in the drug product with an LOQ of at least the maximum acceptance level.

Perform Leachable Study

Put real samples into storage under normal and stress conditions (e.g. ICH conditions). Analyze the samples using the methods developed earlier.
As each study is unique, and tailored to the customer's specific needs, details of the program are agreed using a written protocol.

Services Leachables and Extractables Syringes

Syringes