ASTM International - ASTM E1298-89(1994)

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

historical
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Organization: ASTM International
Publication Date: 1 January 2000
Status: historical
Page Count: 3
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
Terminology2
Significance and Use3
Purity4
General Considerations4.1
Estimation of Purity4.2
Impurities5
General Considerations5.1
Major and Minor5.2
Nature and Consequences of5.3
Contaminants6
General Considerations6.1
Effects of contaminants6.2
Methods 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.

Document History

November 1, 2006
Standard Guide for Determination of Purity, Impurities, and Contaminants in Biological Drug Products (Withdrawn 2014)
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...
ASTM E1298-89(1994)
January 1, 2000
Standard Guide for Determination of Purity, Impurities, and Contaminants in Biological Drug Products
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...
January 1, 2000
Standard Guide for Determination of Purity, Impurities, and Contaminants in Biological Drug Products
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...
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