The review justifies the need to validate the linearity, relative accuracy, and precision of Related Substances methods for detecting unidentified substances. Various approaches and methods for the estimation of linearity, precision, relative accuracy, and other validation characteristics for unidentified impurities are considered. The conditions necessary for the correct application of these approaches are discussed. The term “main unidentified impurities” is proposed and justified for assessing the validation results. Acceptance criteria, examples, and recommendations are provided.

中文翻译：

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检测不明物质的相关物质测定方法的验证（综述）

该审查证明需要验证相关物质检测未识别物质方法的线性度、相对准确度和精密度。考虑了用于估计未识别杂质的线性度、精密度、相对准确度和其他验证特征的各种方法和方法。讨论了正确应用这些方法的必要条件。建议使用术语“主要未鉴定杂质”并证明其合理用于评估验证结果。提供了验收标准、示例和建议。