Final Container Extractables & Leachables Study
A final container extractables and leachables study for the presentation that reaches the patient. We test the assembled container closure system under real storage conditions, identify migrating compounds and assess patient exposure against established safety thresholds.
We offer an excellent platform for extractables and leachables study of vial, stopper and PFS.
Our services include:
- Container closure selection and integrity test;
- Container closure extractables and leachables study using GC-FID, GC-MS/MS, ICP-MS, LC-MS/MS;
- Toxicological safety assessment of extractables and leachables.
