ASTM-E1298 › Historical Revision Information
Standard Guide for Determination of Purity, Impurities, and Contaminants in Biological Drug Products
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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.
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
To find similar documents by ASTM Volume:
11.06 (Biological Effects and Environmental Fate; Biotechnology)
To find similar documents by classification:
11.120.10 (Medicaments Including medical prescriptions and medicinal herbs)
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Document Number
ASTM-E1298-89(1994)
Revision Level
1989 R94 EDITION
Status
Superseded
Modification Type
Reapproval
Publication Date
May 26, 1989
Document Type
Guide
Page Count
3 pages
Committee Number
E48.02