Extractables & Leachables Virtual Tour
Compliance and Customization.
Capabilities and Capacity.
Collaboration and Consultation.
Extractables & Leachables testing services uniquely designed and inspired by our clients, for our clients:
- Can your Lab customize testing strategies to meet your individual project and compliance goals?
- Does your Lab have comprehensive capacity and capabilities to manage projects of any size?
- Will your Lab partner with you to develop scientific solutions and deliver successful outcomes?
View our E&L Virtual Tour
Compliance & Customization. Capabilities & Capacity. Collaboration & Consultation.
Extractables & Leachables testing services uniquely designed and inspired by our clients, for our clients.
Compliance & Customization
With unsurpassed scientific talent & state-of-the-art laboratory equipment, we design your project based on intended use of component and applicable guidance documents.
Our extractables studies follow guidances as outlined in USP <1663> and <1664>, as well as FDA/CDER/CBER and EMEA, PQRI, BPSA and BPOG documents.
Our Team of more than 50 expert scientists lead you through the process of choosing the proper sample preparation and extraction techniques.
Whether Container Closure, Delivery Device, or Single Use System, we’ll assist you in designing Extractions appropriate for the intended use of the material.
Capabilities & Capacity
Testing for Extractables by numerous techniques allows for generation of a comprehensive extractables profile. LC/MS-TOF for example, is utilized to determine the accurate mass of observed extractable compounds.
As part of Eurofins’ largest global network, we utilize our proprietary database of more than 1,300 compounds to identify extractable compounds observed by LC/MS-TOF.
Head Space & Direct Injection GC/MS are used to evaluate the presence of volatile & semi-volatile organics. Both NIST and Wiley databases are referenced to assist in the identification of observed compounds.
Included in Extractables profiling is a screen for over 30 elemental impurities by ICP-OES & ICP/MS including the class 1, 2A, 2B and 3 elements listed in ICH Q3D.
Collaboration & Consultation
Backed by our 55-year track record of fostering thousands of client relationships and satisfaction, we approach each project as a vested partnership; when your project succeeds, we succeed.
Our extractables data packages have been included in FDA submissions for over 12 years with a 100% acceptance rate.
Behind every good service is a great scientist
This is where it all comes together. It's one thing to have state-of-the-art instrumentation and facilities, yet quite another to house some of the industry's brightest scientific minds who transform science into an outstanding service experience.
Extractables & Leachables testing services uniquely designed and inspired by our clients, for our clients