Extractables and Leachables
(E&L) Testing
Extractables and Leachables Assessments
Throughout the production journey from starting materials to GMP storage, and eventual administration to the patient, a drug product will contact manufacturing components including packaging systems, delivery devices and in-use components. These interactions may result in the migration of substances (leachables) from these materials into the drug product.
Assessment of extractable and leachable substances is important to ensure that the overall quality of a drug product (safety, identity, strength and purity) is not impacted. PharmSky have extensive knowledge in extractable and leachable assessments and can provide this service to support your product submission. We provide E&L services from early to late phase product development including:
Risk Assessment
PharmSky can assist clients to review manufacturing process components, container closure systems and/or device materials for extractables and leachables and identify high risk components for potential leaching. Recommendations can be suggested to replace high risk materials or components with more suitable alternatives to reduce risk.
E&L Strategy and Study Design
PharmSky can design E&L studies specific to the product, taking into consideration the risk assessment, dosage form, route of administration, dose frequency and duration, toxicity classification, drug formulation and product contact materials. Feasibility studies may be conducted to determine sample preparation, extraction conditions, instrument capability and suitability of test methods.
Extractables Studies
Controlled extraction studies are performed to generate an extractables profile to determine material compatibility, assist with container closure selection and identify potential leachables for further toxicological assessment.
Method Development and Validation
Develop and validate analytical methods for quantitation of extracted materials.
Leachables Evaluation
Assess the drug product for leachables at predefined time points over the product’s shelf life. In addition, PharmSky has dedicated GMP storage facilities to support E&L testing.
Compound Identification
PharmSky is equipped with highly sensitive instruments that provide accurate mass analysis for confident identification of unknowns.
Our Expertise in E&L Testing
PharmSky is equipped with specialised instruments including UPLC-QToF MS, GC-MS and GC-MS/MS to accurately identify and quantify extractable and leachable substances. We offer customised protocol driven E&L testing services to help ensure that your product meets applicable regulatory requirements and is safe for patient use. Our experienced scientific team has performed E&L studies for various products, and is fully conversant with applicable standards and regulatory requirements.
Our expertise includes, but is not limited to:
- Inhalation Products
- Ophthalmics
- Injectables (lyophilised products and parenteral solutions)
- Topicals
- Dermal Patches
Additionally, we have an extensive working knowledge of plasticisers, dyes, polymer species, phthalates, polycyclic aromatic hydrocarbons (PAHs), antioxidants, lubricants and curing agents typically used in the manufacturing of packaging and device components (rubber stoppers, glass vials, syringes, pre-filled syringes, inhalation devices, injectable bags, films, blister packs, large volume containers, plastic bags) as well as in process manufacturing components.
PharmSky can provide a custom extractables and leachables program specific to your product and appropriate to the phase of development. Contact PharmSky for your E&L testing needs.
Why Choose PharmSky To Partner With?
PharmSky can provide comprehensive analytical services for these compounds, utilising both internationally recognised methods and unique in-house analytical approaches.
Our team offers guidance on method selection, sampling techniques, and assistance in interpreting test outcomes.
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FAQs For Extractables and Leachables Testing
Extractables are organic or inorganic chemical species that can be extracted from packaging materials, delivery systems or manufacturing equipment under extreme conditions. Extractables studies are used to generate a material profile and identify potential leachables.
Leachables are organic and inorganic chemical species that migrate into the drug product under normal product use or storage conditions. Drug products are assessed for leachables at predefined time points over the product’s shelf life.
- GC-MS/MS for volatile and or semi-volatile organic compounds
- LC-QTof MS for non-volatile organic compounds
- ICP-MS for elemental impurities
- Inhalation Products
- Ophthalmics
- Injectables (lyophilised products and parenteral solutions)
- Topicals
- Dermal Patches
- Medical devices (chemical characterisation)
Depending on the development phase, E&L studies typically include:
- Initial evaluation of product contact materials (processing components, packaging system etc.) to identify potential sources of extractable and leachable impurities.
- Development and validation of analytical methods.
- Studies including extractables assessment of container closure system and processing components (USP General Chapter <1663> Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems)
- Evaluation of leachables in drug products throughout shelf-life (USP General Chapter <1664> Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging/Delivery systems.)