QOS应注明拟定的杂质限度是如何限定的。
The QOS should state how the proposed impurity limits are qualified.
为了保证最后产品的纯度，对起始物质应当建立一个适当的杂质限度。
Appropriate limits should be set in the specifications of the starting material, in order to ensure appropriate purity of the final substance.
元素杂质在最终原料药中的限度会根据CE P持有人实施的情况包括在CEP上。
Limits for elemental impurities in the final substance, as implemented by the CEP holder will be included on the CEP.
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