Objective: To quantify drugimpurity 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。
2
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。
3
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.