Element’s advanced metals speciation analysis services offer valuable insights into the oxidation state, organic complex, and/or combination of oxidation state and chemical form of metals present in a wide range of sample matrices and finished products, including pharmaceuticals, biologics, medical devices, dietary supplements and nutraceuticals, and more.
While some metals are needed to support normal metabolic function, others present a risk to human health, being known to cause toxic effects. Elemental speciation analysis enables a greater, more detailed understanding and evaluation of the potential benefits and risks elements present in the sample being analyzed, including determining toxicity. Given that bioavailability, toxicity, and mobility properties vary considerably depending upon the species of the element, precise characterization of metals species is critical.
Metal speciation pertains to aspects of both the physical and chemical form of an element, including oxidation state, stoichiometry, coordination, and physical state. Trace metal speciation studies provide particularly insightful data, as trace metals can be differentiated from their overall elemental composition into various redox species, organometallic compounds, complexes, or minerals and precipitates. Accurate and reliable elemental speciation analysis is crucial, as different species of metals impact health and safety in various ways, and the species or chemical form, or oxidation state, of an element determines its mobility, toxicity, and bioavailability.
Elemental speciation studies and programs
Element has a proven track record of success developing and implementing comprehensive trace metal speciation studies. State-of-the-art ion and liquid chromatography, coupled with inductively coupled plasma - mass spectrometry (ICP-MS) or with post-column reaction techniques, allow us to provide high-quality results and achieve ultra-trace limits of detection. Examples of our metal speciation programs include:
- Metals speciation in biomolecules;
- Determining organic vs inorganic arsenic in algae and seaweed supplements;
- Measuring inorganic selenium in organoselenium pharmaceuticals;
- Verifying the absence of As(V) in As(III) raw materials, and
- Performing analyses of highly toxic hexavalent chromium in environmental samples and nutritional supplements.
As establishing metal speciation is more difficult than determining total metals present within a sample, partnering with the right contract research organization (CRO)/contract development and manufacturing organization (CDMO) is key. Our teams of consultative, highly skilled scientists have the depth and breadth of expertise to develop and validate methods for trace metal speciation. Perform more comprehensive risk assessments and make informed decisions throughout the product development lifecycle with Element’s comprehensive metal speciation services.
Speciation analysis of elements
- Arsenic (As)
- Selenium (Se)
- Chromium (Cr)
- Mercury (Hg)
- Vanadium (V)
- Lead (Pb)
- Thallium (Tl)
- Manganese (Mn)
The Element advantage
From metal speciation of pharmaceuticals and biologics to the characterization of element species in nutraceuticals and dietary supplements, our comprehensive metals speciation services provide valuable data that can inform risk assessments and ensure materials and products are safe and effective. Element’s metals speciation services support a wide range of applications and industries, including pharmaceuticals, biologics, medical devices, dietary and nutritional supplements, nutraceuticals, raw materials, consumer products, environmental samples (air, soil, and water), and more. Additionally, state-of-the-art Ion and Liquid Chromatography, coupled with Inductively Coupled Plasma - Mass Spectrometry (ICP-MS) or with post-column reaction techniques, allows us to provide high-quality results.
To learn about our extensive metal speciation services and elemental speciation studies, or to speak with one of our experts, contact us today.
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Element is a recognized world-leader in trace metal analysis, providing testing for elemental impurities by ICPOES and ICPMS in compliance with USP, EP (2.4.20), and ICH Q3D guidelines.
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