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Standard Guide for Determination of Purity, Impurities, and Contaminants in Biological Drug Products
STANDARD published on 1.1.2000
Designation standards: ASTM E1298-89(1994)
Note: WITHDRAWN
Publication date standards: 1.1.2000
SKU: NS-41174
The number of pages: 3
Approximate weight : 9 g (0.02 lbs)
Country: American technical standard
Category: Technical standards ASTM
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
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:
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. |
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