The Challenge:
Even widely used packaging materials can release unexpected compounds into pharmaceutical products, including oligomers, antioxidants, and degradation products detectable only at trace levels. As regulatory scrutiny around extractables and leachables (E&L), analytical laboratories face a growing challenge: identifying unknown migrants before they become a product safety issue. The increasing complexity of modern drug products, combined with the growing use of polymer-based packaging materials, single-use systems, and advanced delivery devices, has significantly expanded the scope of E&L testing. At the same time, regulatory agencies expect more comprehensive characterization of packaging-related risks throughout the product lifecycle.
Our Approach:
CLS has developed extensive methodologies for designing studies to identify extractables and leachables in drug products. We conduct extractable studies for a broad range of primary packaging materials, and leachable studies for parenteral and IV drug products. Volatile, semi-volatile, non-volatile compounds and elemental impurities are measured using different analytical techniques.
Our Expertise
We bring over five years of specialized experience in Extractables and Leachables (E&L) studies for pharmaceutical container closure systems, performed in accordance with applicable USP requirements (USP<1663> and <1664> )and regulatory expectations.
We have successfully executed about 75 + E&L projects, covering various Container closure systems, Parental products and Primary and Secondary packing materials. Our expertise enables us to deliver scientifically robust, reliable, and regulatory-compliant analytical solutions to support pharmaceutical and medical device manufacturers throughout product development and regulatory submissions.
A dedicated analytical team conducts these studies and interprets data from relevant analytical platforms.
Why It Matters
Track Record
Applications
- Pharmaceutical packaging materials
- Container Closure Systems (CCS)
- Primary and secondary packaging
- Parental Product
- Ophthalmic Product
Regulatory Standards
Instrumentation
Standards & Compliance
Every test we perform adheres to globally recognized regulatory frameworks.