What are Extractables and Leachables Studies?
Extractables and leachables (E&L) studies are an in-depth analytical investigation of the chemical interactions between a container closure system or drug delivery system, its packaging components and a drug product or pharmaceutical formulation. The primary purpose of the investigation is to identify any potential chemicals derived from the interaction of the constituent parts, and then determine the impact to safety and/or efficacy that those chemicals pose to human health. This is often termed an extractables/leachables profile. Organizations that seek to provide guidance for E&L studies include the FDA, ICH and USP.
What are Extractables?
Extractables are substances in a device or container closure system which can be “pulled out” using stressing conditions such as strong solvents, elevated temperatures and increased surface area. Substances observed in this stage are characterized and identified per FDA guidelines and further evaluated by a toxicologist to determines if the substance is a potential hazard. Common extractables include plasticizers, surfactants, processing aids, degradants and container closure system dependent materials.
What are Leachables?
Leachables are substances in the device or container closure system that leach or “come out” under normal conditions of exposure over the natural lifespan of a product. In a well-designed E&L study, observed leachable substances have typically been identified as an extractable. Sources of leachables are potentially numerous and can include ink and adhesives from labels or secondary packaging material. Known extractables and leachables are monitored according to FDA guidelines to ensure human exposure levels do not exceed appropriate safety limits.
Extractables and Leachables Studies at EKG Labs
Understanding the complex chemical interactions between pharmaceuticals and materials is critical to designing a proper extractables and leachables program. The head of our analytical team, Dr. Allen Kesselring, is known throughout the medical device development industry for designing and managing large E&L programs. We can perform E&L analytical studies with the ultimate goal of submitting data for FDA review and approval. EKG Labs is familiar with guidance from respected organizations such as ICH and USP. Our capabilities include:
- Full scale GMP analytical extractables and leachables programs
- Drug-Device Biocompatibility Studies
- Method Development
- Method Validation
- Chemical Characterization
- Impurity Identification
- Storage and Stability
Extractables and Leachables Analytical Techniques at EKG Labs
- Chromatographic Characterization – HPLC, LC/MS, GC, GC/MS, GC/FID, GC/TCD, GPC/SEC,
- Spectroscopy Characterization – ICP-MS, NMR, MS, PXRD, TF-XRD, UV-Vis, FTIR, Raman
- Extraction Techniques – Soxhlet, Reflux, Immersion, Agitation