Extractables & Leachables from Container and Closure Systems
ICH Topic Q6A requires the determination of the level of extractables and leachables from containers and closure systems. Development and stability data should demonstrate that extractables from container/closure systems are consistently below levels that are acceptable and safe.
SGS M-Scan has developed in-house validated methods for the analysis of plasticizers and leachables from rubber seals, tubing and containers as well as analysis methods for other extractables.
All SGS M-Scan services are provided on a fully confidential basis and reports are peer reviewed. When required by the client, studies are conducted in accordance with the GLP/GMP Compliance Programmes.