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。
Main component self-compare without calibration factor can also be used when there is no impurity reference substance.
当没有杂质对照品时，也可采用不加校正因子的主成分自身对照法。
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