Objective: To quantify drug impurity by the limitation detection of the convolution spectrum system.
目的:利用褶合光谱仪中杂质限量检测功能对药物中杂质进行定量分析。
Therefore, it is essential that the dosage-form manufacturer evaluate each supplier's drug substance impurity profiles.
因此,剂型生产商评估每个供应商原料药的杂质情况是相当重要的。
Quality assessment of starting materials from multiple sources and the impact of starting material impurities on the impurity profile of the drug substance are discussed with illustrative examples.
从多重来源的起始原料的定量分析和起始原料中的相关物质对药物中的相关物质的影响在本文中也通过具体例子进行了讨论。
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