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首页> 外文期刊>International Journal of Pharmaceutics >Towards quality assessed characterization of nanomaterial: Transfer of validated protocols for size measurement by dynamic light scattering and evaluation of zeta potential by electrophoretic light scattering
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Towards quality assessed characterization of nanomaterial: Transfer of validated protocols for size measurement by dynamic light scattering and evaluation of zeta potential by electrophoretic light scattering

机译：朝纳米材料的质量评估表征：通过电泳光散射通过动态光散射和Zeta电位评估尺寸测量的验证方案转移

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摘要

Quality control analysis of nanomaterials has been identified as a major issue to pursue their development in different industrial fields including nanomedicine. One difficulty is the lack of standardized and validated protocols suitable to achieve their characterization. In a previous work, we have developed standardized protocols for the evaluation of the size and zeta potential of nanomaterials based on methods described in the ISO standard and have performed validation of each one. The present work was aimed to transfer these protocols in three independent receiving laboratories. No official guideline was described in the literature to achieve such a transfer. A comparative study for receiving laboratories equipped with the same instrument as the sending laboratory was designed based on the Code of Federal Regulation edited by the Food and Drug Administration. For the receiving laboratory equipped with an instrument working at a different wavelength, a new validation was designed and applied. Corresponding statistical methods were used for the analysis of the results. A successful transfer of the protocols in all receiving laboratories was achieved. All laboratories recorded consistent results applying in blind the protocol of size measurements on two samples of nanomaterials from which included one reference. (C) 2017 Elsevier B.V. All rights reserved.
机译：纳米材料的质量控制分析已被确定为在包括纳米医生的不同工业领域开发的主要问题。一个难度是缺乏适合实现其特征的标准化和验证的协议。在以前的工作中，我们已经开发了基于ISO标准中描述的方法的纳米材料的尺寸和Zeta电位的标准化协议，并且已经执行了每个方法。目前的工作旨在将这些协议转移到三个独立的接收实验室。文献中没有官方指南赘述，以实现这样的转移。根据食品和药物管理局编辑的联邦调节守则，设计了接收与送实验室相同仪器的实验室的比较研究。对于配备在不同波长工作的仪器的接收实验室，设计并应用了一种新的验证。相应的统计方法用于分析结果。成功转移了所有接受实验室的议定书。所有实验室都录制了一致的结果，其在盲目中申请了大小测量方案，其中纳米材料的两个样本包括一个参考。 （c）2017年Elsevier B.V.保留所有权利。

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