About Element Santa Fe Springs Health Sciences
Santa Fe Springs Health Sciences is a full service laboratory offering high quality and quick turnaround testing services. Started in 1984 as an analytical chemistry testing laboratory, it quickly became the first commercial facility to offer ICPMS for metals testing in various matrices.
Our engaged experts specialize in a wide-variety if fields extractables and leachables, full monograph raw materials testing, trace metals in hundreds of matrices, NMR, as well as GC, GCMS, LC, IC, FTIR, amongst others.
The laboratory is registered and audited by the FDA, accredited by A2LA for ISO/IEC 17025 and holder of a USDEA regulated drugs license, as well as a radioactive materials license.
Santa Fe Springs Health Sciences Services
Excipient Raw Materials and Container Testing
Element offers complete analytical bundles. USP container testing methods are provided for a broad range of polymers and glass containers. Our engaged experts can supply extractables and leachables testing studies to demonstrate that your package meets the required specifications.
Elemental Impurity Testing and Validation
Element tests for elemental impurities by ICPMS and ICPOES in compliance with USP, EP, and ICH to give you reliable, independent data for a broad range of finished products and raw materials in the pharmaceutical, medical device, consumer product and dietary supplement industries.
Extractables and Leachables Studies
Our experience, advanced equipment and in-depth knowledge of materials and the regulations result in the efficient and successful completion of E/L testing programs for pharmaceutical packaging and manufacturing equipment as well as medical devices.
Pharmaceutical Method Development and Research Services
Element provides an array of forced degradation and stability studies and assay development services including protocol design, Identification of degradation products and development reports.