Technique

技术

Particle size measurement

性能试验中的粒径测量

(dynamic light scattering; laser diffraction measurement) as a property test

（动态光散射；激光衍射测量）

Performance characteristic

性能特征

Validation study methodology

验证研究的方法学

Specificity/ Selectivity

专属性/选择性

Absence of interference:

无干扰:

Evaluate blank and sample to determine the appropriateness of the equipment settings and sample preparation

评估空白和样品以确定仪器设置和样品制备是否合适

Precision

精密度

Repeatability:

重复性：

Test at least 6 replicates using established analytical procedure parameters at target range

使用建立的分析方法参数在目标范围内进行至少6次重复测定

Intermediate precision:

中间精密度：

Analysis performed on different days, environmental conditions, analysts, equipment setup

不同日期、不同环境条件、不同分析员、不同仪器设置完成分析

Accuracy

准确度

Technology inherent justification:

技术固有的合理性论证:

Confirmed by an appropriate instrument qualification

通过适当的仪器确认

or

或者

Orthogonal procedure comparison:

与正交方法对比:

Qualitative comparison using a different technique, like optical microscopy, to confirm results

使用不同的技术（如光学显微镜法）进行定性对比以确认结果

Reportable Range

可报告范围

Technology specific justification, e.g., particle size range covered

技术特有的合理性论证，例如覆盖的粒径范围

Robustness and other considerations (performed as part of analytical procedure development as per ICH Q14)

耐用性和其它考虑因素（按照Q14作为分析方法开发的一部分进行）

Deliberate variation of parameters, e.g.,

参数的有意改变，例如，

Evaluation of expected size ranges for the intended use of the analytical procedure

根据分析方法的预期用途评估预计粒径范围。

Dispersion stability for liquid dispersions (stability over potential analysis time, stir rate, dispersion energy equilibration or stir time before measurement)

湿法分散的分散体稳定性（电位分析时间、搅拌速率、色散能量平衡或测量前搅拌时间）

Dispersion stability for dry dispersions (sample amount, measurement time, air pressure and feed rate)

干法分散的分散体稳定性（样品量、测量时间、气压和进样速率）

Obscuration range (establish optimum percentage of laser obscuration) Ultrasound time/percentage for sample, if applicable

遮蔽范围（确定激光遮蔽的最佳百分比）样品超声时间/超声百分比，如适用