第1阶段:方法设计与开发

在第1阶段的准备过程中定义一个分析目标特征(ATP),展示方法性能特征如何符合所需标准,并考虑总体测量的不确定性。通过质量源于设计(QbD)概念深入了解方法性能的影响因素,帮助您从一开始就确保方法的稳定性。

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深入了解设计与开发

Videos / Webinars
Improving Analytical Method Performance Through Quality Risk Management and a Design of Experiments Approach

Applying Quality-by-Design approaches to analytical method development has many benefits. It emphasizes the identification of the sources of variability and their impact on method performance.

Analytical Quality-by-Design Based Method Development for the Analysis of Formoterol, Budesonide, and Related Compounds Using UHPLC-MS

Analytical methods are required to be developed at different stages of the pharmaceutical product life cycle. Two of the most widely used strategies for method development are: one-factor-at-a-time (OFAT) and analytical quality-by-design approach (AQbD).

Blogs / Articles
Modern Perspectives on Method Development: An Interview with Dr. Fadi Alkhateeb

Dr. Fadi Alkhateeb of Waters Corporation discusses his recent method development work.

What does it mean to develop a good LC method?

With Method Lifecycle Management (MLCM) we focus not only on the quality of the analytical method but also on the quality of the reportable result. The goal is to generate quality data across the life of a method.

App notes / Tech briefs
Automated Peak Tracking Using Mass Detection and Fusion QbD Software

Tracking peaks across different chromatograms in the method development process can be challenging. This is because sample components could shift, switch retention times, or even coeleute under different separation conditions. Many method development protocols rely on ultra violet (UV) spectral data only to track peaks. Despite the potential benefits of such protocols they can still have some limitations.

App notes / Tech briefs
BEH C18 Batch-to-Batch Robustness for the Analysis of Rosuvastatin

The goal of a method development process is to find a well-working and robust method that consistently delivers the expected performance throughout its lifecycle. This process can be very complex and time-consuming, especially if multiple chromatographic parameters need to be explored.

Blogs / Articles
Modern Tools and Risk-Based Method Development Strategies Pave the Way for a New Generation of Analytical Methods

In the pharmaceutical industry there’s a shift and it’s changing the way we think about and develop analytical methods. Change can be uncomfortable, but when the driving forces are to ensure data quality, make better decisions and improve patient outcomes, how can we resist?

视频/网络研讨会
在方法开发中使用ACQUITY QDa质谱检测器进行UV正交检测
现代技术加深方法理解/提高方法质量

沃特世的Paula Hong说明了如何在方法开发中使用ACQUITY QDa质谱检测器进行UV正交检测。

视频/网络研讨会
使用配有ACQUITY QDa质谱检测器的UPLC 系统和AutoBlend Plus技术进行杂质分析的方法开发
现代技术加深方法理解/提高方法质量

ACQUITY QDa质谱检测器有助于高效、稳定的方法开发,尽量减少通过保留时间鉴定色谱峰所需的标准品。本视频证明,在方法开发中使用ACQUITY QDa质谱检测器获得的定性质谱数据,可以对盐酸齐拉西酮和相关化合物的定性结果进行确认。

应用纪要/技术简报
使用Empower 3 CDS软件提高方法开发过程中的决策能力
提高方法开发过程中的决策能力

减少变异性来源是MLCM流程的关键。Empower评分报告可以让用户根据指标选择最佳的方法条件,而不是个人判断。评分报告可以让用户快速找到符合预设标准(ATP)的条件 — 避免方法开发过程中由分析人员引入的差异和偏差。本技术简报介绍了Empower 3软件中对色谱分离进行评分的自定义计算和自定义报告功能。

应用纪要/技术简报
在液相色谱方法开发中实施系统性筛选策略的全面解决方案
系统性方法开发:提高方法稳定性,缩短产品上市时间

本白皮书介绍了一套协同性的系统方案,方案采用UPLC仪器、亚2 μm填料的色谱柱以及Empower 3软件,为用户提供了一套精简的方法开发方案。

应用纪要/技术简报
USP方法案例研究第1期:了解样品制备和流动相稳定性的影响
了解方法条件

在下面的研究中,我们对阿托伐他汀的USP分析进行了仔细评估。为尽量减少环境条件的影响,使用USP章节621中允许的方法对样品制备和流动相组成进行控制。这些研究有助于科学家设计相关策略,尽量减少在多个跨地区实验室间转移USP方法产生的任何偏差。

应用纪要/技术简报
开发适用于药物稳定性研究的色谱分析方法
将AQbD用于方法开发

本文介绍了一项案例研究,该研究使用质量源于设计(QbD)理念开发稳定性分析方法,监测口服混悬剂中阿莫西林粉末的降解情况。文中说明了QbD如何使用Fusion QbD软件来选择因素值组合、创建采集方法以及评估模型响应值。