Pharmaceutical drug products (DP) can contain foreign impurities due to contact with manufacturing, storage, distribution and administration systems. These foreign impurities (leachables) are leached from these systems by the drug product and can be linked to extractables measured in the systems during laboratory investigations.

Assessing the impact of leachables on the suitability of the DP requires that it be screened to discover, identify and quantify leachables. Given the large number and great chemical diversity of potential leachables, an analytical strategy involving multiple, orthogonal analytical methods is necessary to generate a complete leachables profile.

Once the profile has been delineated, the effect of leachables on the DP's suitability can be established. The potential adverse effect of leachables on patient safety can be established via chemical safety risk assessment, which involves comparing a DP user's (patient) exposure to individual leachables with exposure thresholds which are toxicologically established for the individual leachables.

药物产品（DP）可能会由于与制造，存储，分销和管理系统接触而含有异物。这些外来杂质（可浸出物）是由药品从这些系统中浸出的，并且可以与实验室研究过程中在系统中测得的可萃取物联系起来。

评估可浸出物对DP适用性的影响要求对其进行筛选，以发现，识别和量化可浸出物。鉴于潜在可浸出物的数量众多且化学多样性很大，因此需要一种涉及多种正交分析方法的分析策略来生成完整的可浸出物轮廓。

一旦描述了轮廓，就可以确定可浸出物对DP的适用性的影响。可以通过化学安全风险评估来确定可浸出物对患者安全的潜在不利影响，该评估涉及将DP用户（患者）对单个可浸出物的暴露与通过毒理学确定的单个可浸出物的暴露阈值进行比较。