大家对ICH Q3A可能是非常熟悉了，其中有一段话对相关物质最终结果的表述作了非常明确的规定，作为药品分析人员，你注意到了吗？实际工作中你是这样操作的吗？ Quantitative results should be presented numerically, and not in general terms such as “complies”, “meets limit” etc. Any impurity at a level greater than (>) the reporting threshold (see Attachment 1) and total impurities observed in these batches of the new drug substance should be reported with the analytical procedures indicated. Below 1.0%, the results should be reported to two decimal places (e.g., 0.06%, 0.13%); at and above 1.0%, the results should be reported to one decimal place (e.g., 1.3%).
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