im体育APPal Impurities 测试 和 Analysis

拥有数十年的化学分析和监管专业知识, we deliver industry-leading, highly accurate element-specific 协议, advanced analytical method development, 和 validation in accordance with USP <232>/<233> 和 我Q3D guidelines for elemental impurities testing in drug products, down to necessary trace level limits of detection.

在药物开发和生产的几乎任何阶段, impurities, contaminants, 残留物可以被引入到制药和生物制药产品中. The presence of elemental impurities in raw materials, active pharmaceutical ingredients (APIs), drug product, 而且，即使是最稳健的市场路径，包装材料也可能造成重大破坏, 由于药品不符合必要的规定, 包括由国际协调委员会(我Q3D) 和 The United States Pharmacopeial Convention (USP <232> 和 <233>). 

Effective January 1, 2018, 小分子和大分子药物的制造商必须符合中概述的规范 USP <232> 和 <233> im体育APP杂质检测指南，已与我Q3D指南全球统一. USP和ICHim体育APP杂质检测指南提倡一种基于风险的方法来评价和控制药品中的im体育APP杂质, 或单个im体育APP的允许日暴露量(PDE), 确保生产过程不含有毒金属. 应考虑所有im体育APP杂质的潜在来源, including those intentionally added during synthesis (e.g., catalysts), 那些可能存在于用于制备药品的材料中的物质, 以及任何可能从制造设备或容器封闭系统引入的im体育APP.

im体育APPal impurities testing capabilities

im体育APP的专业和经验丰富的科学家团队在开发和验证定制方面有着良好的记录, specific elemental impurities methods, 协议, 研究设计具有挑战性的api和复杂的样品矩阵与精确的痕量水平检测, including those with poor solubility. 我们在USP重金属测试和生物制剂和药品im体育APP杂质测试方面拥有深厚的专业知识, along with a variety of advanced techniques, 包括ICP-MS结合个性化样品制备方法和使用三种碰撞气体, 允许对通常被多原子干扰遮蔽的im体育APP进行低水平检测.g., sulfur 和 silicon. 一般, 钙等im体育APP的检测限为十亿分之一(ppb), 钠, 钾, 和 silicon, 对于选定的im体育APP和应用，可以达到万亿分之一(ppt)的检测限. Furthermore, with the use of advanced sample preparation techniques, our scientists can analyze challenging sample matrices, such as plastics, lubricants, 和 pharmaceuticals, with the use of our microwave digestion system. 

我们全面的质量控制解决方案支持控制产品和生产过程中的im体育APP杂质, including batch-to-batch testing, raw material testing, method optimization 和 refinement, 并在生产过程中进行精细化，以防止im体育APP杂质在未来的挑战.

为im体育APP杂质风险评估项目提供专家监管支持

在我们咨询团队的支持下，最大限度地提高im体育APP杂质风险评估的有效性. As your collaborative, 战略合同开发和制造组织(CDMO)合作伙伴贯穿整个药物开发生命周期, 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 impurities in drug products if finished product ingredients do not meet st和ards for elemental impurities control.

im体育APPal impurities testing services

• im体育APPal impurity testing
• Implementation of 我Q3D elemental impurities guideline
• USP <232>/<233> implementation of elemental impurity 筛选
• Method development 和 validation
• Limit test validation
• Quantitative method validation
• Semi-quantitative 筛选
• Trace metal analysis
• Targeted metals analysis
• Monograph (compendial) testing
• Extractables 和 leachables studies
• API 和 drug substance testing
• Raw materials testing
• Finished product testing
• Stability studies
• Batch 和 lot release testing
• Metal speciation
• Impurity characterization

im体育APPal impurities sample preparation techniques

• 关闭d-vessel microwave digestion
• Open-vessel microwave digestion
• Wet chemical digestion
• Acid digestion
• Base digestion
• Solvent extraction
• Reflux extraction

The im体育APP advantage

凭借im体育APP深厚的监管知识，确保对小分子和大分子药品中的im体育APP杂质进行控制, consultative approach, well-equipped laboratory, 并证明了在复杂和具有挑战性的样品中实现最佳方法的成功. 我们的端到端解决方案包括监管驱动的im体育APP杂质风险评估支持, elemental impurities USP <232>/<233> 和 FDA 我Q3D testing programs, 筛选, batch-to-batch testing, raw material testing, method development, validation, 和 optimization. We offer a customized approach to method development, 使用分析技术，提供精确到痕量水平的最准确结果.

了解我们的定制方法来控制药物和生物制剂中的im体育APP杂质, or to speak with one of our experts, contact us 今天.