Extractables and Leachables Testing

Extractables and Leachables Testing
Product Description

Solvias provides expert testing and consulting services for Extractables & Leachables in single-use process materials and container closure systems. With our proprietary EXLEA database, we provide unique automated high throughput screening of more than 6000 Extractablesusing Accurate Mass LC/MS/MS Technology at trace levels. Benefiting from its vast experience in trace analysis using accurate mass LC/MS/MS and GC/MS in complex matrices, Solvias has the capability to provide high quality services for the investigation of E&L in accordance with PQRI, BPOG,EMEA, USP and FDA guidelines.

Solvias AG

  • CH
  • 2015
    On CPHI since
  • 500 - 999
    Employees
Company types
Contract Research Organisation (CRO)
Primary activities
Analytical Services

Solvias AG

  • CH
  • 2015
    On CPHI since
  • 500 - 999
    Employees
Company types
Contract Research Organisation (CRO)
Primary activities
Analytical Services

More Products from Solvias AG (10)

  • Analytical Services

    Product Analytical Services

    Solvias provides cGMP-compliant contract analytical services to help you ultimately provide safer products to consumers. We provide a comprehensive range of analytical services to the pharmaceutical, biotech, medical devices and cosmetics industry with similar regulatory requirements for raw materia...
  • Biopharmaceutical Analysis

    Product Biopharmaceutical Analysis

    Solvias has a solid reputation with market-leading biopharmaceutical companies for the characterization and QC analysis of monoclonal antibodies (mAbs), glycoproteins, PEGylated proteins and peptides and biosimilars (follow-on biologics).. This means that businesses of all sizes, even smaller biotechs, can...
  • Custom Synthesis

    Product Custom Synthesis

    Solvias has all the experience, resources and expertise required to meet your custom synthesis and manufacturing needs.
    Custom synthesis:  lead synthesis up to 20 kg or more / synthesis of scaffolds and building blocks / synthesis/isolation of reference compounds
    Process R&D for: chiral inte...
  • Biological Analysis

    Product Biological Analysis

    Solvias provides high calibre microbiology, chemistry, toxicology and cell biology services according to GMP, CGMP (FDA), GLP and ISO 17025 standards.Testing for sterile and non-sterile products / Environmental testing / Specialised studies (antibiotics, integrity testing, alternative methods) / Endoxin an...
  • Catalysis Technology

    Product Catalysis Technology

    Solvias has a proven track record for the efficient and successful development of catalytic processes. This world-wide recognized expertise spans from discovery (catalyst evaluation) to the production of multi kg batches under optimized reaction conditions.

    Solvias’ areas of technical expert...
  • Cell and Gene Therapy

    Product Cell and Gene Therapy

    Solvias offers a comprehensive range of orthogonal analytical methods for ATMPs. Our cell and gene therapy building blocks include raw materials testing, cell culture media specific analysis and oligonucleotide analytics. For gene therapies, vector analytics covers the full range of AAV or LV release a...
  • Ligands

    Product Ligands

    Solvias provides wide range of catalysis and ligands which includes ligands. It offers over 700 own ligands and catalysts in its portfolio, all having well-known industrial applications for asymmetric hydrogenation and CX-coupling. Every ligand in portfolio is synthesized through key common intermediates. ...
  • Quality Control and Release Analysis

    Product Quality Control and Release Analysis

    Solvias provides wide range of analytical services which includes quality control and release analysis. The analyses are routinely performed at Solvias according to GMP quality standards for drug substances & products, intermediates, starting materials and excipients. Contact us for more information.
  • Solid-State Development

    Product Solid-State Development

    Solvias provides an integrated and comprehensive approach to solid-state development – from systematic salt, co-crystal, and polymorph screening to controlled scale-up of the crystallization process, all complemented with the full range of physico-chemical studies performed in our laboratories.
  • Stability Studies

    Product Stability Studies

    Solvias offers the complete range of stability studies according to ICH guidelines for drug development and follow-up stability studies, covering all ICH standard storage conditions as well as low temperature storage. All our processes take place on one connected site, where there is a high degree of QC ex...

Solvias AG resources (2)