ASTM E1298-89(1994)

ASTM E1298-89(1994) - 1.1.2000

1. Scope

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:

Section
Terminology	2
Significance and Use	3
Purity	4
General Considerations	4.1
Estimation of Purity	4.2
Impurities	5
General Considerations	5.1
Major and Minor	5.2
Nature and Consequences of	5.3
Contaminants	6
General Considerations	6.1
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.