分析方法开发 & 验证

im体育APP’s regulatory and industry experts have a proven track record of successfully developing and 验证 fit-for-purpose, 准确的, and reliable analytical methods based on established CDER/ICH and FDA guidelines and procedures for highly complex formulations and sample matrices.

分析方法的发展, 验证, and transfer are integral to any small or large molecule drug development program. Analytical methods can be developed to establish the identity, 效力, 物理特性, and purity of an active pharmaceutical ingredient (API) in compounded dosage forms, as well as identify and quantify impurities, 赋形剂, 中间体, 原材料, 防腐剂, 抗氧化剂, 和更多的. To establish consistent scientific soundness of a method and ultimately safeguard patient safety, any analytical methods used to analyze drug products or drug substances for regulatory submissions must be validated, as required by regulatory agencies at various stages of the drug development and approval process. Rigorous method 验证 establishes the accuracy, 精度, 线性, 特异性, 选择性, 检测和定量限, and robustness of an analytical method.

Our flexible and customized solutions, including phase-appropriate analytical method development and 验证, are tailored to meet your specific needs throughout the drug development lifecycle, from early-stage protocols to late-stage quality control method optimization.

GMP analytical method verification, transfer and optimization

Monograph and compendial methods found in pharmacopeias have been validated, 除非另有说明, full 验证 is not required prior to use. 然而, verification is needed to confirm that the method is suitable for its intended purpose, 包括具体的药品, 物质矩阵, 使用条件. Our consultative analytical method development services team has extensive experience and expertise in method verification techniques, including those detailed in USP <1226> Verification of Compendial Procedures.

当你与im体育APP合作时, analytical method transfers are smooth and efficient with standard operating procedures and protocols, whether products require comparative testing or inter-laboratory method 验证. Our consultative analytical experts are available to train teams at receiving sites, ensuring regulatory requirements are met, including those detailed in USP <1224> Transfer of Analytical Procedures. 类似的, im体育APP can easily carry out the transfer of developed methods to production sites, and our highly skilled method development scientists can seamlessly transfer existing analytical methods into our laboratories for direct testing use and/or optimization.

Experience with a wide variety of sample matrices

• 平板电脑
• 胶囊
• 悬浮液
• 注射剂
• 栓剂
• 粉末和颗粒
• 糖浆
• 吸入剂
• 口服和外用液体
• 面霜、软膏和凝胶
• 组合产品

im体育APP优势

We offer a comprehensive suite of flexible and customized solutions, including phase-appropriate method development and 验证, to meet your needs at every stage of the drug development life cycle. With a strong foundation of proven success in developing, 验证, 优化, and transferring complex and challenging analytical methods and purposefully equipped laboratories with a wide range of advanced analytical instrumentation, our analytical method development services team has the expertise and knowledge to take on highly complex compounds and drug products.

To learn more about how im体育APP can deliver high-quality, validated methods or to speak with one of our experts, im体育APP 今天.