Trace Metal Testing and Analysis Services

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.

通过Element全面的痕量金属测试和im体育APP分析服务，确保产品的完整性和安全性. 先进的电感耦合等离子体质谱(ICP-MS)和电感 coupled plasma – optical emission spectroscopy (ICP-OES) techniques, in addition to hyphenated ICP-MS 而稳健的金属分析方法，为微量im体育APP分析提供了坚实的基础. 我们的咨询科学家拥有深度和广度的专业知识和先进的仪器，为广泛选择的重金属测试方法提供广泛的分析和痕量金属分析技术, 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. im体育APP的微量im体育APP分析专家也可以开发和验证强大的分析方法的检测和形态金属在一系列样品矩阵.

With the use of three collision gases, Element技术高超的科学家们已经证明了他们能够实现低水平检测和超痕量灵敏度，这些im体育APP通常被多原子干扰(例如.g., sulfur and silicon). 我们先进的微量金属分析技术通常可以达到十亿分之一(ppb)的检测限制，如硅im体育APP, sodium, potassium, and calcium. Moreover, 对于特定的im体育APP和应用，可以达到万亿分之一(ppt)的检测限制. A variety of sample preparation techniques are available, 使我们能够有效地分析具有挑战性的活性药物成分(api)和复杂的样品基质, 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 -通过药品中im体育APP的分离和形态，可以进行彻底的风险评估, 允许更详细地评估特定样本中的im体育APP所带来的利益和风险. 越来越多的研究表明，游离im体育APP和各种束缚态的毒性差异很大, im体育APP的形态对确保产品的安全性和有效性将变得更加关键. 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完整的im体育APP形态解决方案支持广泛的应用和im体育平台app下载, including pharmaceuticals, biologics, food, agricultural products, dietary supplements and nutraceuticals, consumer products, and more.

ICH Q3D and USP 232/233 elemental impurities testing -药品中im体育APP杂质的来源可能包括金属催化剂, 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, 美国食品和药物管理局(FDA)要求对所有新的和现有的药物进行im体育APP杂质测试 USP 232/233 - a mandate that has been in effect since January 1, 2018. Element的im体育APP杂质测试服务包括特定于im体育APP的协议, method development and validation to USP <232>/<233>, and ICH Q3D guidance for elemental impurities in drug products. 确保Elementim体育APP杂质检测服务符合FDA ICH Q3D法规要求.

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. 一些监管机构专注于杂质的控制，并为最终剂型中的杂质设定了接触限值, 要求在生产前和生产后对小分子和大分子药物的污染源进行风险评估. Element的咨询监管和科学专家团队拥有数十年分析有机杂质的经验, inorganic (elemental) impurities, and residual solvents, as well as characterizing unknown materials and substances.

Pharmaceutical contaminant analysis and complaints investigations – Detect, identify, control, 并通过Element的药物污染物分析和投诉调查服务防止污染. 我们的科学家在识别过程相关的有机杂质方面具有成熟的专业知识, inorganic impurities, and solvents, in addition to determining the root cause of contamination. Element的全套污染物和投诉调查服务产品成功克服了污染带来的挑战.

California Proposition 65 metals testing – California’s Prop 65 right-to-know law 保护个人，告知他们可能接触到的产品可能含有一种或多种化学物质，这些化学物质在立法中详细列出，可能超过既定的安全阈值. im体育APP微量im体育APP分析服务包括致癌im体育APP检测, 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 -膳食补充剂和营养保健品销售和标签符合USP或NF标准必须符合 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. 今天与Element合作，确保膳食补充剂和营养保健品符合指南中允许的每日暴露量(PDE)限值和值.

The Element advantage

Element提供全面的痕量金属测试和分析服务，从单im体育APP或多im体育APP分析，为您量身定制独特的样品矩阵, including multi-analyte assays and methods for heavy metals (e.g., mercury, cadmium, arsenic, 和铅)完成痕量金属和im体育APP分析质量控制程序. 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.