Trace Metal Testing and Analysis Services

Our comprehensive testing suite covers metals speciation analysis, ICH Q3D and USP 232/233 elemental impurities testing, and unknown identification. We handle specific testing requirements for California Proposition 65 metals, including arsenic, beryllium, cadmium, lead, hexavalent chromium, and mercury compounds. Our USP <2232> analysis ensures dietary supplements meet all permitted daily exposure limits.

Our tests include: 

• Metals speciation analysis 

• ICH Q3D and USP 232/233 elemental impurities testing 

• Pharmaceutical unknown identification and impurity testing 

• Pharmaceutical contaminant analysis and complaints investigations 

• California Proposition 65 metals testing 

• USP <2232> testing of elemental contaminants in dietary supplements and nutraceuticals 

From raw materials to finished products, we analyze pharmaceuticals, biologics, drug substances, medical devices, nutraceuticals, and supplements. Our expertise extends to complex matrices including plastics, lubricants, and specialized pharmaceutical components. We test materials from every stage of manufacturing, including catalysts, processing aids, inorganic materials, container closures, and water sources. 

We employ multiple sample preparation techniques optimized for your specific materials:

• Closed-vessel microwave digestion for complete dissolution 

• Open-vessel block digestion for complex matrices 

• Solvent extraction for organic compounds 

• Reflux extraction for difficult materials 

• Acid, base, and wet chemical digestion for specialized needs Each method is validated to handle challenging active pharmaceutical ingredients and complex sample matrices. 

Metals Speciation Analysis 
Element measures metal species at ultra-trace levels using advanced ICP-MS techniques and chromatography methods, enabling detailed risk assessments of elements in drug products. This is critical because different forms of the same element can have vastly different toxicity profiles. This service supports a wide range of industries, ensuring product safety by analyzing both free and bound metal states. 

ICH Q3D and USP 232/233 Elemental Impurities Testing 
Element provides elemental impurities testing for drug products as required by the FDA, including method development and validation for USP <232>/<233> and ICH Q3D. This ensures compliance with FDA regulations for elemental impurities in pharmaceuticals. 

Pharmaceutical Unknown Identification and Impurity Testing 
Element identifies and quantifies impurities in drug products, helping assess their safety and efficacy. Our experts analyze organic, inorganic, and residual solvents, ensuring compliance with regulatory exposure limits for both small and large molecules. 

Pharmaceutical Contaminant Analysis and Complaints Investigations 
Element helps detect and resolve contamination issues in pharmaceuticals by identifying organic and inorganic impurities, solvents, and the root causes of contamination. Our comprehensive services support process improvements and regulatory compliance. 

California Proposition 65 Metals Testing 
Element provides testing for over 900 chemicals regulated under California's Prop 65 law, including carcinogenic and reproductive toxic elements like arsenic, cadmium, and lead, using ICP-MS for trace elemental analysis. 

USP <2232> Testing of Elemental Contaminants in Dietary Supplements and Nutraceuticals 
Element offers testing to ensure dietary supplements and nutraceuticals meet USP <2232> guidelines for elemental contaminants. We specialize in testing arsenic, cadmium, lead, and mercury to ensure compliance with permitted daily exposure limits. 

Our advanced instrumentation includes ICP-MS systems with three collision gases specifically designed to overcome polyatomic interferences, particularly with sulfur and silicon analysis. Our ICP-OES technology delivers exceptional precision, while hyphenated systems couple ICP-MS with LC, GC, and ion chromatography for comprehensive analysis capabilities.

Our team operates from Life Sciences hubs across the world, providing global access to our expert capabilities. Find your nearest Life Sciences hub on our Locations Page.