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ASTM E1298-06

Current Revision

Standard Guide for Determination of Purity, Impurities, and Contaminants in Biological Drug Products (Withdrawn 2014)

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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.

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 biological drug product. These methods are not intended to be all-inclusive. The methods used by an individual manufacturer must be specific to the product and process of production.

SDO ASTM: ASTM International
Document Number E1298
Publication Date Nov. 1, 2006
Language en - English
Page Count 4
Revision Level 06
Supercedes
Committee E55.04
Publish Date Document Id Type View
Nov. 1, 2006 E1298-06 Revision
Jan. 1, 2000 E1298-89R00 Reaffirmation
Jan. 1, 2000 E1298-89R94 Reaffirmation