Extractables and Leachables Studies

Extractables and leachables (E/L) studies quantify potential leachable impurities that originate from pharmaceutical container closures, process equipment and medical device packaging

Extractables and leachables (E/L) studies are critical to the identification and quantification of harmful leachable impurities which could migrate from pharmaceutical container closure systems, process equipment and packaging to contaminate pharmaceutical products.

A profile of extractable components must be obtained, via controlled extractables studies (CES), in order to identify potential sources of leachables such as antioxidants, plasticizers, dyes and metal catalysts. As pharmaceutical packaging, drug delivery systems and implantable medical devices can be extremely complex, with mixtures of plastic, polymer, rubber or glass materials, printed surfaces and coatings all utilized, it is critical that E/L studies are designed specifically for your drug product and the container materials so that the risks associated with leachable impurities can be assessed.

Our scientists conduct extractables and leachables studies in accordance with regional guidance, Good Manufacturing Practice (GMP) PQRI recommendation, United States Pharmacopeia (USP) requirements (including USP chapters <1663>, <1664>, and <1664.1>), and awareness of FDA guidelines. As an initial step, we aim to gather all information about your packaging system in order to obtain a strong impression of potential sources of extractables or leachables. The combination of our experience in method development for controlled extractables studies, coupled with our vast knowledge of leachable compounds, mean that we can anticipate and identify potential sources of risk through strategic screening studies.

We provide leachables method validation compliant to Good Manufacturing Practice (GMP) for use in storage and stability programs  and can support a wide range of closure or drug delivery systems such as pre-filled syringes, large volume parenteral products, orally inhaled and nasal drug products (OINDP), single use and disposable medical equipment, printed packaging and bioprocessing equipment. Leachables associated with drug delivery systems, implantable medical devices and other devices such as e-cigarettes are also assessed. 

Our analytical teams can determine both organic and inorganic contaminants through the application of  a range of instrumentation including liquid chromatography (HPLC) liquid chromatography-mass spectrometry (LC-MS(MS)), gas chromatography (GC), gas chromatography-mass spectrometry (GC-MS(MS)), and inductively coupled plasma spectroscopy (ICP, ICP-MS), dependent on the analysis. 

With specialists in glass delamination studies, we provide a range of solutions that help mitigate the risks associated glass delamination and leaching of metal ions /elemental impurities from glass into drug products for molded bottles, containers, vials or prefillable syringes. 

Comprehensive evaluation and safety assessment review of laboratory E/L study data is performed by our in-house toxicologist consultants in order to identify and address potential risks and to assist with comprehensive impurity testing, whilst identifying any gaps in your existing data packages. We also provide recommendations and support for preparation of very low-risk data packages related to E/L testing.

Extractable Leachables Specialists
Our experts have over 25 years’ experience in specialised analytical and toxicology assessment for extractables and leachables, and this is reinforced by our knowledge of polymer, plastic and packaging materials, allowing us to identify components from the most complex polymer formulation including adhesives, additives and stabilizer ingredients and their degradation products. Our consultants provide a first-class evaluation and assessment of existing E/L data gaps, and through strategic screening or quantitative studies, we offer the right study for your product. Intertek also provides recommendations and support for preparation of very low risk data packages related to E/L testing.

Good Manufacturing Practice (cGMP) Services

• GLP and cGMP Method Development, Validation and Remediation
• Good Manufacturing Practices (GMP) Batch Release Testing
• cGMP Quality Control Testing
• Elemental Analysis and Trace Metals Testing for Pharmaceuticals
• cGMP Stability Studies
• Pharmaceutical Impurity Testing
• Reference Standard Materials Program
• Solid State Characterisation
• Inhalation Drug Product Development Support
• Formulation Development
• Clinical Trial Materials Manufacturing
• Pharmaceutical Regulatory Affairs Services
• Pharmaceutical Auditing

Global Expertise
Intertek offers extractable and leachable testing services through GMP-compliant laboratories located in Whitehouse, NJ (USA) and Basel (Switzerland) with research support from our Mumbai (India) facility, as part of our commitment to Total Quality Assurance. Bringing quality and safety to life, we offer Total Quality Assurance expertise to help you to meet and exceed quality, safety and regulatory standards.