im体育APP杂质测试与分析

With decades of combined chemical analysis 和 regulatory expertise, 我们提供im体育平台app下载领先的服务, 高度精确的特定im体育APP协议, 先进的分析方法开发, 和 验证 in accordance with USP <232>/<233> 和 我Q3D guidelines for elemental 杂质 testing in 药物产品s, 降低到必要的痕量水平的检测极限.

At almost any stage of drug development 和 manufacturing, 杂质, 污染物, 和 residuals can be introduced into pharmaceutical 和 biopharmaceutical products. 原料中im体育APP杂质的存在, 活性药物成分(api), 药物产品, 和 包装 materials can cause significant disruption to even the most robust path-to-market, as 药物产品s will not comply with necessary regulations, including those set by The International Council for Harmonization (我Q3D) 和 The United States Pharmacopeial Convention (USP <232> 和 <233>). 

1月1日生效, 2018, manufacturers of small 和 large molecule drugs are required to meet the specifications outlined in USP <232> 和 <233> elemental 杂质 testing guidance, which has been globally harmonized with 我Q3D guidelines. The USP 和 ICH elemental 杂质 testing guidance promote a risk-based approach for the evaluation 和 control of elemental 杂质 in 药物产品s, or permitted daily exposures (PDE) for individual elements, to ensure manufacturing processes are free from toxic metals. All potential sources of elemental 杂质 should be considered, 包括在合成过程中有意添加的那些.g., 催化剂), those potentially present in materials used to prepare 药物产品, 和 any elements that may be introduced from manufacturing equipment or container closure systems.

im体育APP杂质测试能力

im体育APP’s teams of dedicated 和 experienced scientists have a proven track record of developing 和 validating customized, 特定im体育APP杂质法, 协议, 和 study designs for challenging APIs 和 complex sample matrices with accurate trace level detection, 包括溶解度差的. Our deep expertise in USP heavy metals testing 和 elemental 杂质 testing of biologics 和药品, 还有各种先进的技术, including ICP-MS coupled with individualized sample preparation methods 和 the use of three collision 气体es, allow for low-level detection of elements that are typically obscured by polyatomic interferences (e.g.硫和硅. 一般, detection limits are sub parts per billion (ppb) for elements such as calcium, 钠, 钾, 和硅, 和 sub parts per trillion (ppt) detection limits can be achieved for select elements 和 applications. 此外, 采用先进的样品制备技术, 我们的科学家可以分析具有挑战性的样本矩阵, 比如塑料, 润滑剂, 和药品, 使用我们的微波消化系统. 

Our comprehensive suite of quality control-focused solutions support the control of elemental 杂质 in product 和 production processes, 包括批对批测试, 原料测试, 方法优化与细化, 和 production process refinement to prevent elemental 杂质 challenges in the future.

Expert regulatory support for elemental 杂质 risk assessment programs

Maximize the effectiveness of your elemental 杂质 risk assessment with the support of our consultative team. 作为你的合作者, strategic contract development 和 manufacturing organization (CDMO) partner throughout the entire drug development lifecycle, our knowledgeable team can provide recommendations 和 alternative options that meet the st和ards set forth in USP <232>/<233> 和 我Q3D regulatory guidance for the control of elemental 杂质 in 药物产品s if finished product ingredients do not meet st和ards for elemental 杂质 control.

im体育APP杂质检测服务

• im体育APP杂质测试
• 我Q3Dim体育APP杂质指南的实施
• USP <232>/<233> implementation of elemental impurity 筛选
• 方法开发和验证
• 极限试验验证
• 定量方法验证
• 半定量检测
• 微量金属分析
• 目标金属分析
• 专著(药典)测试
• 可萃取物和可浸出物研究
• 原料药和原料药检验
• 原材料测试
• 成品检验
• 稳定性研究
• 批和批放行测试
• 金属物种形成
• 杂质特性

im体育APP杂质样品制备技术

• 密闭容器微波消解
• 开式容器微波消解
• 湿化学消解
• 酸消化
• 基本消化
• 溶剂萃取
• 回流提取

im体育APP优势

Ensure the control of elemental 杂质 in small 和 large molecule 药物产品s with im体育APP’s deep regulatory knowledge, 咨询的方法, 装备精良的实验室, 和 proven success in achieving optimal methods for complex 和 challenging samples. Our end-to-end solutions include regulatory-driven elemental 杂质 risk assessment support, elemental 杂质 USP <232>/<233> 和 FDA 我Q3D testing programs, 筛选, 批次测试, 原料测试, 方法开发, 验证, 和优化. 我们为方法开发提供定制的方法, using analytical techniques that provide the most accurate results down to trace levels.

To learn about our customized approach to controlling elemental 杂质 in pharmaceuticals 和 biologics, 或者找我们的专家谈谈, im体育APP 今天.