Analytical Chemistry Laboratory Services

The Analytical Chemistry Laboratory in Menlo Park is recognized as an ISO 17025 accredited laboratory (A2LA Certificate 2561.03). As applicable, the laboratory testing services are compliant with CFR 21 Part 58, U.S. FDA Good Laboratory Practices (GLP), and the laboratory holds a DEA registration for Schedules I–V. The focus areas of our facilities include the following:

  • Chromatographic methods:
    • Gas chromatography-mass spectrometry (GC/MS, TD-GC/MS; both liquid and vapor injection modes)
    • Ultra-high-performance liquid chromatography-QTOF mass spectrometry (UHPLC/MS, with tandem LC/MS/MS and photodiode array (PDA) detection capabilities)
    • Gel permeation chromatography (GPC) with refractive index (RI) and light scattering dectors (GPC-MALS)

  • Spectroscopy:
    • Fourier-transform infrared (FTIR – transmission and ATR)
    • UV/Vis Spectrophotometer
    • Access to Raman and other spectroscopic instrumentation

  • Microscopy: 
    • Optical microscopy
    • Optical profilometry
    • Scanning electron microscopy (SEM)
    • Focused ion beam/transmission electron microscopy (FIB-TEM)
    • Non-destructive 3-D X-ray computed tomography (microCT)
  • Water content: Karl Fischer (KF) titration

  • Glove boxes for reactive or air-sensitive chemistry

Extractables and Leachables Testing per ISO 10993-18

Exponent routinely performs extractable and leachable protocols for a variety of materials in accordance with ISO 10993-18 and GLP support as required. Simulated-use, exaggerated, and exhaustive extractions can be conducted on devices or components to identify the quantities of the isolable material present. The analytical data produced can support toxicological risk assessments on components of concern by one of our in-house toxicologists or can be provided directly to the client for their own analysis.

Purity and Contamination Assessment

Our staff has extensive experience conducting purity assessments of pharmaceutical compounds in compliance with compendial methods (United States Pharmacopeia, USP) via UHPLC under GLP as required. We also have capabilities for developing and validating non-compendial and other custom methods for challenging matrices.

Since contamination can occur on surfaces and in products across many industries, we are prepared to assist clients when downstream contamination issues arise—whether at the formulation-level in products such as cosmetics, adhesives, and lubricants, or the system-level, at bonded interfaces, in assembled devices, on printed circuit boards, and elsewhere.

Method Verification

Our experts have assisted clients with quality assurance (QA/QC) test method validation to ensure that SOPs are properly developed and implemented. In addition to onsite manufacturing audits, we can assist in the verification and implementation of existing methods, either during technology transfer matters or other instances where analytical method adaptations are needed.

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