Trace metal services

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Comprehensive services for metal and trace element testing

Analysis of metal speciation – The separation and speciation of elements in a therapeutic product provide thorough risk assessments, enabling more in-depth analyses of both the advantages and hazards presented by elements within a specific sample. The speciation of elements will become even more crucial to guaranteeing product safety and efficacy as more research shows that free elements and various bound forms differ substantially in toxicity. Our skilled experts use cutting-edge ICP-MS based techniques and procedures, such as coupling ICP-MS with chromatography (LC, GC, Ion chromatography, etc.), to quantify metal species to ultra-trace levels. The whole variety of applications and industries supported by Element’s elemental speciation solutions, including medicines, biologics, food, agricultural products, nutritional supplements, and nutraceutical, consumer  products and more.

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 impurity testing and unknown identification

Impurities can affect both the safety and efficacy of medicinal products, thus it is crucial to identify, quantify, qualify, and regulate them during the drug development process. Risk assessments that take into account sources of contamination in small and large molecule pharmaceuticals both before and after manufacture are necessary since several regulatory bodies are focused on the management of impurities and have set exposure limits for contaminants in final dosage forms. Teams of consulting regulatory and scientific experts from Element have years of experience characterizing unidentified compounds and chemicals as well as analyzing organic impurities, inorganic (elemental) impurities, and residual solvents.

Pharmaceutical contaminants analysis and investigations into complaints:

MedWatch Global pharmaceutical contaminant analysis and complaints investigation services can help you detect, identify, control, and avoid contamination. In addition to figuring out the source of contamination, our experts have demonstrated proficiency in identifying process-related organic impurities, inorganic impurities, and solvents. With Element’s comprehensive array of contaminant and complaints investigation service solutions, you may successfully overcome the difficulties that contamination poses.