1.1本指南涵盖了生物药物产品中纯度、杂质和污染的概念。 1.2本指南建议了此类产品中杂质和污染物的测定方法。 1.3本指南安排如下: 1.4本标准无意解决与其使用相关的所有安全问题（如有）。本标准的用户有责任在使用前制定适当的安全和健康实践，并确定监管限制的适用性。 ====意义和用途====== 本指南建议了制药行业内普遍采用的分析方法，以识别和定量生物药物制剂中存在的杂质和污染物的水平。这些方法并非包罗万象。单个制造商使用的方法必须针对产品和生产过程。

1.1 This guide covers the concepts of purity, impurity, and contamination in biological drug products. 1.2 This guide suggests methods for determination of impurities and contaminants in such products. 1.3 This guide is arranged as follows: 1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. ====== Significance And Use ====== This guide suggests analytical methods generally applied within the pharmaceutical industry to identify and quantitate the level of impurities and contaminants present in the preparation of a biological drug product. These methods are not intended to be all-inclusive. The methods used by an individual manufacturer must be specific to the product and process of production.