What are Extractables and Leachables Studies?
Extractables and leachables (E&L) studies are in-depth analytical investigations of the chemical interactions between a container closure 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 to determine the impact to human health and/or drug efficacy that those chemicals pose. This identification is 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/or 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 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. Sources of leachables are potentially numerous and can include ink and adhesives from labels or secondary packaging material. FDA guidelines monitor known extractables and leachables 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 organizations such as ICH and USP. Our capabilities include:
- Full scale GMP analytical extractables and leachables programs
- Method Development
- Method Validation
- Chemical Characterization
- Impurity Identification
- Elemental Impurities Analysis
- Storage and Stability
Read More About Specific E&L Guidances
- USP general chapters 1663 and 1664
- USP 661, USP 661.1, USP 661.2, and USP 661.3 (now USP 665)
- ISO 10993 Biocompatibility
- BPOG Extractables and Leachables
Extractables and Leachables Analytical Techniques at EKG Labs
- Chromatographic Characterization – HPLC, LC/MS, 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