痕量金属测试和分析服务

作为世界公认的痕量金属分析的领导者, 领先的组织信任Element来检测, identify, 并量化药物中的微量金属, biologics, 药物的物质, 药物产品, 医疗设备, 原材料, 成品, 保健品, 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 耦合等离子体光学发射光谱(ICP-OES) 技术，除了 用连字符连接icp 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, 包括药典方法，如 USP <232> and USP <233>, EP/Ph. Eur. (2.4.20)，以及BP和JP方法，和 ICH Q3D im体育APP杂质. 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.

使用三种碰撞气体, 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.(硫和硅). 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. 各种样品制备技术是可用的, enabling us to effectively analyze challenging active pharmaceutical ingredients (APIs) and complex sample matrices, 包括塑料, lubricants, 和药品. 样品制备技术包括密闭容器微波消解, 开式闭塞消化, 溶剂萃取, 回流提取, and acid, base, 湿化学消化.

全面的金属及微量im体育APP检测服务

金属形态分析 – 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. 我们经验丰富的科学家测量金属到超痕量水平, 采用基于ICP-MS的先进技术和方法, including 耦合ICP-MS与色谱法 (LC、GC、离子色谱等.). Element’s complete elemental speciation solutions support a wide range of applications and industries, 包括药品, biologics, food, 农产品, 膳食补充剂和营养品, 消费产品, and more.

ICH Q3D和USP 232/233im体育APP杂质检测 –Sources of elemental impurities in 药物产品 can include metal catalysts, 生产设备, 加工助剂, 原材料, 原料药(API), 无机材料, 有机材料, water, 初级集装箱封闭, and solvents. im体育APP杂质一直是药品的一个关键问题, and the US Food and Drug Administration (FDA) requires elemental impurities testing for all new and existing drugs to USP 232/233 -自2018年1月1日起生效的一项授权. Element’s elemental impurities testing services include element-specific protocols, method development and validation to USP <232>/<233>, and ICH Q3D 药品中im体育APP杂质指南. Ensure compliance to FDA ICH Q3D regulatory requirements with Element’s elemental impurities testing services.

药物未知物鉴定及杂质检验 -身份证明, quantitation, 资格, 控制杂质对药物开发至关重要, 因为杂质会影响药品的安全性和有效性. 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, 无机(im体育APP)杂质, and 残留溶剂，以及表征未知的材料和物质.

药品污染分析和投诉调查 – 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, 无机杂质, and solvents, 除了确定污染的根本原因. Successfully overcome the challenges contamination presents with Element’s complete suite of contaminant and complaints investigation service offerings.

加州65号提案金属测试 ——加州的 65号提案知情权法 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, 包括砷, beryllium, cadmium, lead, 和六价铬. Additionally, 我们的科学家可以测试导致生殖毒性的im体育APP, 包括镉和铅, 以及优先列出的汞化合物, 第二优先列表是镍和镍化合物.

USP <2232> testing of elemental contaminants in 膳食补充剂和营养品 – 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 膳食补充剂和营养品 comply with the permitted daily exposure (PDE) limits and values within the guidance.

im体育APP优势

Element’s comprehensive trace metal testing and analysis services range from single or multi-element analyses tailored to your unique sample matrix, 包括重金属的多分析物测定和方法.g., mercury, cadmium, arsenic, and lead) to complete trace metals and elemental analysis quality control programs. 控制药品中的im体育APP杂质和重金属, biologics, 医疗设备, 原材料, 膳食补充剂, 以及更多来自Element的痕量金属测试.

了解我们广泛的痕量金属测试和分析服务, 或者找我们的专家谈谈, contact us today.