ASTM E 1298 : 2006
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
Standard Guide for Determination of Purity, Impurities, and Contaminants in Biological Drug Products (Withdrawn 2014)
Hardcopy , PDF
05-08-2014
English
01-11-2006
Committee |
E 55
|
DocumentType |
Guide
|
Pages |
4
|
PublisherName |
American Society for Testing and Materials
|
Status |
Withdrawn
|
Supersedes |
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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ASTM E 2363 : 2014 | Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry |
ASTM F 2150 : 2013 | Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Tissue-Engineered Medical Products |
ASTM F 2883 : 2011 | Standard Guide for Characterization of Ceramic and Mineral Based Scaffolds used for Tissue-Engineered Medical Products (TEMPs) and as Device for Surgical Implant Applications (Withdrawn 2020) |
ASTM F 3089 : 2014 | Standard Guide for Characterization and Standardization of Polymerizable Collagen-Based Products and Associated Collagen-Cell Interactions |
ASTM F 2027 : 2016 | Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products |
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