ASTM-E1298:2006 Edition

$35.75

E1298-06 Standard Guide for Determination of Purity, Impurities, and Contaminants in Biological Drug Products

Published By	Publication Date	Number of Pages
ASTM	2006	4

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Categories: 11.120.10 - Medicaments, ASTM

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Description

ASTM E1298-06

Withdrawn Standard: Standard Guide for Determination of Purity, Impurities, and Contaminants in Biological Drug Products (Withdrawn 2014)

ASTM E1298

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.

Keywords

ICS Code

ICS Number Code 11.120.10 (Medicaments)

DOI: 10.1520/E1298-06

PDF Catalog

PDF Pages	PDF Title
1	Scope Terminology
2	Significance and Use Purity Impurities TABLE 1
3	Contaminants Methods for Determining Impurities and Contaminants

Additional information

Standard Title	E1298-06 Standard Guide for Determination of Purity, Impurities, and Contaminants in Biological Drug Products
Published Code	ASTM
Publication Date	2006
Pages Count	4
ICS Codes	11.120.10 - Medicaments