Область применения

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:

SectionTerminology 2Significance and Use3Purity4 General Considerations4.1Estimation of Purity4.2Impurities5 General Considerations5.1Major and Minor5.2Nature and Consequences of5.3Contaminants6 General Considerations6.1Effects of contaminants6.2Methods for Determining Impurities and Contaminants7

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.