ASTM International - ASTM E1298-06
Standard Guide for Determination of Purity, Impurities, and Contaminants in Biological Drug Products (Withdrawn 2014)
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| Organization: | ASTM International |
| Publication Date: | 1 November 2006 |
| Status: | inactive |
| Page Count: | 4 |
| ICS Code (Medicaments): | 11.120.10 |
significance And Use:
This guide suggests analytical methods generally applied within the pharmaceutical industry to identify and quantitate the level of impurities and contaminants present in the preparation of a... View More
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.
Document History
ASTM E1298-06
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Standard Guide for Determination of Purity, Impurities, and Contaminants in Biological Drug Products (Withdrawn 2014)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...
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...