As a recognized world leader in trace metal analysis, leading organizations trust Element to detect, identify, and quantify trace metals in pharmaceuticals, biologics, drug substances, drug products, medical devices, raw materials, finished products, nutraceuticals, supplements, and more.
Ensure product integrity and safety with Element’s comprehensive trace metal testing and elemental analysis services. Advanced inductively coupled plasma – mass spectrometry (ICP-MS) and inductively coupled plasma – optical emission spectroscopy (ICP-OES) techniques, in addition to hyphenated ICP-MS and robust metal analysis methods, provide a strong foundation for trace elemental analysis. Our consultative scientists have the depth and breadth of expertise and advanced instrumentation to offer a wide range of assays and trace metal analysis techniques to an extensive selection of heavy metals testing methods, including pharmacopeial methods such as USP <232> and USP <233>, EP/Ph. Eur. (2.4.20), as well as BP and JP methods, and ICH Q3D for elemental impurities. Element’s trace elemental analysis experts can also develop and validate robust analytical methods for the detection and speciation of metals in a range of sample matrices.
With the use of three collision gases, Element’s highly skilled scientists have proven their ability to achieve low-level detection and ultra-trace sensitivity of elements which are typically obscured by polyatomic interferences (e.g., sulfur and silicon). Our advanced trace metal analysis techniques routinely achieve sub parts per billion (ppb) detection limits for elements such as silicon, sodium, potassium, and calcium. Moreover, sub parts per trillion (ppt) limits of detection can be achieved for specific elements and applications. A variety of sample preparation techniques are available, enabling us to effectively analyze challenging active pharmaceutical ingredients (APIs) and complex sample matrices, including plastics, lubricants, and pharmaceuticals. Sample preparation techniques include closed-vessel microwave digestion, open-vessel block digestion, solvent extraction, reflux extraction, and acid, base, and wet chemical digestion.
Comprehensive metal and trace element testing services
Metals speciation analysis – Thorough risk assessments are enabled by the separation and speciation of elements in a drug product, allowing for more detailed evaluations of both the benefits and risks presented by elements within a particular sample. As more and more studies demonstrate that free elements and various bound states differ greatly in toxicity, the speciation of elements will become even more critical to ensuring product safety and efficacy. Our experienced scientists measure metal species to ultra-trace levels, using advanced ICP-MS based techniques and methods, including coupling ICP-MS with chromatography (LC, GC, Ion chromatography, etc.). Element’s complete elemental speciation solutions support a wide range of applications and industries, including pharmaceuticals, biologics, food, agricultural products, dietary supplements and nutraceuticals, consumer products, and more.
ICH Q3D and USP 232/233 elemental impurities testing –Sources of elemental impurities in drug products can include metal catalysts, manufacturing equipment, processing aids, raw materials, drug substance (API), inorganic materials, organic materials, water, primary container closure, and solvents. Elemental impurities have always been a critical issue for pharmaceuticals, and the US Food and Drug Administration (FDA) requires elemental impurities testing for all new and existing drugs to USP 232/233 - a mandate that has been in effect since January 1, 2018. Element’s elemental impurities testing services include element-specific protocols, method development and validation to USP <232>/<233>, and ICH Q3D guidance for elemental impurities in drug products. Ensure compliance to FDA ICH Q3D regulatory requirements with Element’s elemental impurities testing services.
Pharmaceutical unknown identification and impurity testing – The identification, quantitation, qualification, and control of impurities is critical to drug development, as impurities can impact both the safety and efficacy of drug products. Several regulatory bodies are focused on the control of impurities and have set exposure limits for impurities in final dosage forms, requiring risk assessments that consider sources of contamination in small and large molecule drugs both pre- and post-manufacturing. Element’s teams of consultative regulatory and scientific experts have decades of experience analyzing organic impurities, inorganic (elemental) impurities, and residual solvents, as well as characterizing unknown materials and substances.
Pharmaceutical contaminant analysis and complaints investigations – Detect, identify, control, and prevent contamination with Element’s pharmaceutical contaminant analysis and complaints investigation services. Our scientists have proven expertise identifying process-related organic impurities, inorganic impurities, and solvents, in addition to determining the root cause of contamination. Successfully overcome the challenges contamination presents with Element’s complete suite of contaminant and complaints investigation service offerings.
California Proposition 65 metals testing – California’s Prop 65 right-to-know law protects individuals by informing them of potential exposure to products which may contain one or more of over 900 chemicals detailed within the legislation that may exceed established safety thresholds. Element’s trace elemental analysis services include testing for carcinogen causing elements, including arsenic, beryllium, cadmium, lead, and hexavalent chromium by ICP-MS. Additionally, our scientists can test for reproductive toxicity causing elements, including cadmium and lead, as well as first priority list mercury compounds, and second priority list nickel and nickel compounds.
USP <2232> testing of elemental contaminants in dietary supplements and nutraceuticals – Dietary supplement and nutraceutical products marketed and labeled as conforming to USP or NF standards must comply with USP <2232> guidance. Element has extensive experience and expertise testing for the four major elements of concern detailed within USP <2232>, arsenic, cadmium, lead, and mercury. Partner with Element today to ensure dietary supplements and nutraceuticals comply with the permitted daily exposure (PDE) limits and values within the guidance.
The Element advantage
Element’s comprehensive trace metal testing and analysis services range from single or multi-element analyses tailored to your unique sample matrix, including multi-analyte assays and methods for heavy metals (e.g., mercury, cadmium, arsenic, and lead) to complete trace metals and elemental analysis quality control programs. Control elemental impurities and heavy metals in pharmaceutical products, biologics, medical devices, raw materials, dietary supplements, and more with trace metal testing from Element.
To learn about our extensive trace metals testing and analysis services, or to speak with one of our experts, contact us today.
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Elemental Impurity Testing and Analysis
Element’s trace metal laboratories provide expert elemental impurities testing and analysis in compliance with USP and ICH Q3D guidelines to ensure the safety of drugs and drug products.
Pharmaceutical Unknown Identification and Impurity Testing
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Element provides advanced metals speciation analysis services to determine the toxicity of a material and to predict its interactions with other compounds.
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