Method Development & Validation
Eurofins Regulatory Science Services offers the agro-chemical, pharmaceutical, chemical and consumer products industries unparalleled expertise in analytical method development, validation and application of a broad range of methodologies.
The know-how established within our laboratories in analytical chemistry is globally applicable to a large variety of matrices including technical and analytical grade substances, formulations, and end use products; air, soil, and water (drinking, ground, surface); crops; human exposure monitoring; animal/human matrices (urine, feces, blood, tissue); and more. These matrices can be tested for an immense number of analytes and contaminants including industrial chemicals, pesticides, pharmaceuticals, persistent organic pollutants (POPs), consumer use products, and heavy metals; along with the metabolites/degradates formed by such contaminants.
Our laboratories accommodate stringent and extensive requirements from a worldwide range of regulatory agencies (EPA, EU/OECD, SANCO, REACH, TSCA etc.), and are able to develop custom methods in order to address analytical challenges to specific complex matrices such as sediment, tissue, and salt water. With service lines in environmental fate and metabolism, environmental toxicology, plant science, and residue chemistry, our experienced staff has the tools and expertise to meet your development and validation needs.
Our Method Development & Validation services include:
- Analytical method development, adaptation, validation, refinement and transfer
- Independent laboratory validation (ILV)
- Development of chiral enantioselective methods for batch/formulation and for residue analysis
- Development, analysis and support of radiolabeled substances (14C and 3H) for chemical and radiochemical purity and for the analysis of metabolites/degradates in environmental fate, plant and animal metabolism, human mass balance, and degradation studies
- Radiochemical validation and extraction efficiency (demonstrating equivalency of different extraction procedures including hydrolysis and enzymatic deconjugation)
- Method development and validation in support of analysis of technical-grade material and formulations for accurate purity determinations and for the determination of production and relevant (toxic or persistent) impurities (including metals analysis) in production batches of pesticides, as well as in general chemicals (“5-batch” analysis, product chemistry, and for REACH registrations)
- Analytical support in environmental toxicity non-target plant, insect, animal or avian studies requiring analysis of residues in many matrices (e.g., water, soil, sediments), insects (including honey bees), earthworms, mammals, fish, birds, and vegetation (herbs, flower heads, grass, seeds, pollen, guttation sap, etc.)
Contact erssinfo@eurofins.com for more information!