Norm

ASTM E1298 - 06 en

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

45,11 54,58 Incl BTW

Over deze norm

Status Definitief
Aantal pagina's 4
Gepubliceerd op 01-11-2006
Taal Engels

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.

Details

Engelse titel Standard Guide for Determination of Purity, Impurities, and Contaminants in Biological Drug Products

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