Extractables and Leachables Testing

Extractables and leachables analysis standard techniques include HPLC-UV, GC-MS, HS-GC/MS, LC-MS, LC-MS-MS, FTIR, ICP-MS, ICP-OES, NVR and TOC.  Biomanufacturer must ensure that a comprehensive extractables and leachables analysis (E&L) is performed to meet regulatory requirements. Performing an Extractables & Leachables (E&L) study is an important part of verifying the safety of a product. Design of an E&L study requires an understanding of the materials used to construct the device and the expected use conditions. The laboratory which conducts the study must have sufficient expertise in unknown identification to properly leverage information from multiple techniques, databases and control experiments to allow for positive unknown identification. They must also have the breadth of instrumentation which allows for analysis of a wide range of potential analytes. At the same, they must also be experts at analytical method development so that they can utilize this knowledge to develop  quantitative methods for the components identified.

Eurofins Lancaster Laboratories

Eurofins Lancaster Laboratories Environmental provides NELAP-accredited scientific services in the environmental sciences with comprehensive environmental lab facilities. Lancaster Environment Testing includes Volatiles, Semivolatiles, Waste Characterization, and other services during the drug development process. The specialized services include raw materials and excipient testing, extractables/leachables testing, container testing on plastics and glass, etc.

Toxikon

Toxikon provide analytical and bioanalytical services ( Toxikon Pharma Analytical Services) with advanced instrumentation, featuring gas chromatography/mass spectrometry  (GC/MC), gas chromatography (GC), high performance liquid chromatography  (LC), interfaced with specialized chromatographic detectors, LC/MS, LC /MS/MS and all standard laboratory instruments. Toxikon’s Analytical and Bioanalytical Services include: Method Development and Validation, Dose Analysis and Verification, Sample Analysis, Extractables and Leachables, API, Metabolite Synthesis and Identification.

WuXi AppTec

Biologics/Advanced Therapies offer U.S. based services range from IND-enabling GMP cell banking/cell line characterization programs and toxicology programs through to the development, validation and execution of GMP lot release, as well as stability assays for clinical and commercial production lots. Analytical Chemistry Services of Extractables and leachables for single-use systems in biologics manufacturing has all GC-MS, Headspace GC-MS, ICP-MS, and LC-MS analytical methods. Additional methods also available if applicable. The toxicology services provides a full range of in vivo and in vitro preclinical safety evaluation studies which are part of our integrated portfolio of drug discovery and development services.

Intertek  

Intertek Bioanalytical Services capabilities include proprietary method development, validation, method transfer, high throughput sample analysis and pharmacokinetic and toxicokinetic support, combined with automated data capture and reporting system. Clinical sample management services are provided for collection and shipment of samples from clinical study sites. Extractables and leachables studies, pharmaceutical impurity testing, elemental analysis and trace metals are included in GMP and CMC services. Regulatory and Toxicology Consulting service also provide a fast-track and cost-effective approach to gain market access for products and comply with global regulations

Sartorius Stedim Validation Services

Sartorius has created extensive extractables and leachable guides to different Sartorius single use components in the context of process validation. Analytical techniques include all standard techniques such as HPLC-UV, GC-MS, HS-GC/MS, LC-MS, LC-MS-MS, FTIR, ICP-MS, ICP-OES, NVR and TOC.

ThermoFisher Scientific

ThermoFisher Scientific offers comprehensive analytical workflows including ICP-MS, GC-MS, LC-MS and advanced information to enable identification and quantification of unknown organic and elemental impurities. Related information include impurity analysis, residual solvent analysis, drug monograph and assay using ion chromatography, antibiotic analysis, etc.

Jordi Labs Extractables and Leachables Testing

Jordi Labs specializes in the analysis of plastics and offfers E&L studies for single-use systems.  Read more about the process used to determine extractables and leachables from plastics in the white paper: Determining Extractables and Leachables in Polymeric Materials.   

Impact Analytical E/L Services   

Impact Analytical detect, identify, and quantitate all extractables and leachables using different instruments,  including:Fourier Transform Infra-red Spectroscopy (FT-IR) for material characterization, DSC and TGA for polymer characterization, Traditional extraction methodologies – Soxhlet, sonication, agitation, Accelerated Solvent Extraction (ASE), Headspace GC-MS for volatiles, GC-MS for volatile and semi-volatile organics, LC-MS, including exact mass for semi- and non-volatile organics, ICP-MS for trace metals, inorganics, Ion Chromatography for inorganics

Avomeen  

Avomeen is specialized in Extractable/Leachable Evaluations, Extractable Screening (Intelligent Planning for Materials Selection), Compatibility of Drug & Packaging, Method Development & Validation for Leachables Study, and Develop Routine Extractable Control Methods, etc.  Related services include Stability Programs, Elemental Impurities, Cleaning & Process Validation, Formulation & Process Development, GMP Small-Batch Manufacturing, and Full Program Support.

Catalent

Catalent product testing services include Manufacturing validation support (process and cleaning validation), Release and finished product testing, Particle sizing and spray analysis, Drug and delivery assays, Stability studies (ICH and custom conditions), Structural elucidation of drug-related impurities and degradation products, Extractables and leachables studies, etc.

Quantex Laboratories

Quantex extractables/leachables capacity include Profile extraction studies, Control extraction studies, Leachables studies

Routine container/closure testing, Formulation compatibility and stability, Identification, isolation and quantification of Extractables and Leachables, storage and stability programs. Instrument capabilities include GC/MS and/or GC-FID (liquid injection, headspace – static & dynamic), LC/MS (PDA, UV, ELSD), ICP and ICP-MS.

VR Analystical

VR analyticals offers extensive extractables and leachables testing services using organic and inorganic analysis tools. Featured testing include Elemental Analysis, Organic Analysis, and Accurate Mass Analysis. Also Consulting on Tangential Flow Filtration, Mass Spectral Interpretation or Processing Material Selection and ENDS testing (E-cigs and e-liquids).

PPD Laboratories

PPD® Laboratories provides full analytical support for extractables and leachables testing and can deliver an integrated toxicity/safety evaluation. Other GMP Lab services include Cell-based Assays, Mass Spectrometry/Structural Elucidation, Microbiology, Physicochemical Material Characterization, and Stability Learn More 

EuTech Scientific Services

EuTech Scientific Services for extractable and leachable services include compendial testing, method development and validation, stability testing, chemical characterization, and other testing such as raw material characterization and formulation compatibility. Learn more.

West Pharma

West offers extractables/leachables analysis for packaging and delivery systems for all pharmaceutical and biological products. Learn More from West Extractables Testing Information Sheet and Analytical Services Brochure.

SGS

SGS offers comprehensive testing for extractables in container materials, medical devices, single-use systems, leachables in final products and on finished container closures. Learn More

3M Purification Inc.

3M purification technical and scientific services offer supports and services such as Extractables and leachables testing, Micro-organism challenge testing, Compatibility testing, Integrity testing, Viability testing, Process design, and Process optimization. Learn More

Exova Extractables and Leachables Studies

Exova extractable and leachables services include material selection for pharmaceutical container closure systems (CCS), complete method development and validation, Toxicological safety assessments, risk assessments and strategy documents, materials characterization and leachables risk evaluation, and On-site training and consulting programs. Learn More

Smithers Rapra Extractables and Leachables Testing

Smithers Rapra provides extractables and leachables testing on a wide range of closure and drug delivery systems, including: Biopharmaceutical products, Pre-filled syringes, Container / Closures , Single Use Systems and Processing Equipment, Medical Devices, Combination Products, Residual Ethylene Oxide (ETO) testing, etc. Learn More

EKG Labs Extractables and Leachable Studies

EKG labs provide full scale GMP analytical extractables and leachables programs, including Method Development, Method Validation, Chemical Characterization, Impurity Identification, Storage and Stability, etc. Learn More

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