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ASTM E 1298 : 2006

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

Standard Guide for Determination of Purity, Impurities, and Contaminants in Biological Drug Products (Withdrawn 2014)
Available format(s)

Hardcopy , PDF

Withdrawn date

08-05-2014

Language(s)

English

Published date

11-01-2006

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.

Committee
E 55
DocumentType
Guide
Pages
4
PublisherName
American Society for Testing and Materials
Status
Withdrawn
Supersedes

ASTM F 2212 : 2011 Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs)
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Based Scaffolds used for Tissue-Engineered Medical Products (TEMPs) and as Device for Surgical Implant Applications (Withdrawn 2020)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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