ASTM International - ASTM E1298-89(1994)
Standard Guide for Determination of Purity, Impurities, and Contaminants in Biological Drug Products
|Publication Date:||1 January 2000|
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:
|Significance and Use||3|
|Estimation of Purity||4.2|
|Major and Minor||5.2|
|Nature and Consequences of||5.3|
|Effects of contaminants||6.2|
|Methods for Determining Impurities and Contaminants||7|
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.