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当定义纳米形态时,批次间差异被理解为什么?

问题(中文)
当定义纳米形态时,批次间差异被理解为什么?
Question (EN)
What is understood as batch-to-batch variability when a nanoform is defined?
中文内容由 Google Cloud Translation 自动生成,仅供参考;请以英文原文为准。问答资料来自欧盟化学品管理局(ECHA)官方网站。
答案(中文)
批次间差异源于制造工艺固有的工艺参数变化,而这些工艺参数由一系列参数(例如起始材料、溶剂、温度、制造步骤顺序等)定义。如果某个参数的变化仅仅是由于批次间差异造成的,那么这些纳米形态仍然被视为相同的纳米形态。然而,如果工艺参数被刻意改变,那么这些纳米形态就是不同的。
Answer (EN)
A batch-to-batch variability results from the variation of process parameters inherent to a manufacturing process that is defined by a series of parameters (e.g. starting materials, solvents, temperature, order of manufacturing steps, etc.). If the variation in a parameter is only due to batch-to-batch variability, then these are still considered as being the same nanoform. However, if there are deliberate changes to the process parameters, then these are different nanoforms.