Extractables and Leachables Studies
Extractables and Leachables testing to quantify and assess risks associated with 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 potentially harmful leachable impurities which could migrate from pharmaceutical container closure systems, medical devices, medical device packaging, and process equipment and packaging to contaminate pharmaceutical products. This can pose a risk to the health of the patient and cause significant quality issues.
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, and polymer and degradation products. 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 specific guidances (EU, US, China), nationally and internationally recognized standards (USP, ISO), 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 high-end analytical instrumentation including liquid chromatography hyphenated with HRAM-mass spectrometry (LC-MS-MS), gas chromatography hyphenated with enhanced resolution or HRAM-mass spectrometry (GC-MS-MS), and inductively coupled plasma spectroscopy (ICP, ICP-MS), dependent on the analysis. In addition to the solvent-based extractions, we also apply various high performance automated solventless extraction methods, such as Solid Phase Microextraction (SPME), dynamic head-space and thermal desorption for better characterisation and understanding of the materials.
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.
Extractables and Leachables Specialists
Our experts have over 30 years of experience in specialised analytical and toxicology assessment for extractables and leachables. 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.
Intertek offers extractables and leachables 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.
- Method development for controlled extractables studies
- Identification of extractables using GC-MS, GC-MS/MS and LC-MS/MS, according to USP <1663> Assessment Of Extractables Associated With Pharmaceutical Packaging/Delivery Systems
- Complex polymer formulation component identification
- Screening or quantitative studies for additives and stabilizer ingredients and their degradation products
- Rapid, decisive identification of extractables including transformation or degradation products
- Modifying specific controlled extractables methods for routine E/L testing
- Extractables studies for medical devices and medical and pharmaceutical packaging
- Complete identification of leachables for pharmaceutical packaging, drug delivery systems, implantable medical devices and other devices such as e-cigarettes
- Method validation compliant to Good Manufacturing Practice (GMP)
- Assessment of leachables according to USP <1664> Assessment Of Drug Product Leachables Associated With Pharmaceutical Packaging/Delivery Systems
- Assessment of specific considerations for leachables in orally inhaled and nasal drug products (OINDP), including metered dose inhalers (MDIs); nasal sprays; inhalation solutions, suspensions, and sprays; and dry powder inhalers (DPIs) according to USP <1664.1>
GMP Laboratory Services
- GMP and CMC Pharmaceutical Laboratory Services
- cGMP Pharmaceutical Stability Studies and ICH Storage
- cGMP Pharmaceutical Quality Control Testing
- Analytical Method Development and Validation
- Glass Delamination Studies for Pharmaceutical Containers
- ICH Q3D Guideline For Elemental Impurities Testing & Risk Assessment
- Inhalation Drug Product Development Services