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[求助] 单抗研发中小分子化合物标准限度问题

咨询:单抗-小分子偶联药物研发中,活性小分子的质量标准如何确定?
毕竟小分子化合物在生物药合成过程中只是一个中间体,但属于活性中间体又不能控制太松,
是否有必要完全按照化学API的标准进行研究;特别是是否必须达到单个杂质≤0.1%、含量≥99.0%等;
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