ASTM-E1298:1994 Edition

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E1298-89(1994) Standard Guide for Determination of Purity, Impurities, and Contaminants in Biological Drug Products

Published By	Publication Date	Number of Pages
ASTM	1994	3

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Category: ASTM

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Description

ASTM E1298-89-Reapproved1994

Historical Standard: Standard Guide for Determination of Purity, Impurities, and Contaminants in Biological Drug Products

ASTM E1298

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:

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.

Keywords

biotechnology; contamination-medical materials/applications; data analysis-environmental; environmental control/fate; genetic examination; impurities; innocuous impurities; purity; purity/impurities/contaminants in biological drug products

ICS Code

ICS Number Code n/a

DOI: 10.1520/E1298-89R94

Additional information

Significance and Use	3
Terminology	2
General Considerations	6.1
Impurities	5
Contaminants	6
Effects of contaminants	6.2
Methods for Determining Impurities and Contaminants	7
Purity	4
Major and Minor	5.2
Nature and Consequences of	5.3
Estimation of Purity	4.2