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Normas ASTM – AENOR
ASTM E1298-89(2000)

ASTM E1298-89(2000)

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

Fecha:
2017-08-16 /Historical
Superseeded by:
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:

Section
Terminology 2
Significance and Use3
Purity4
General Considerations4.1
Estimation of Purity4.2
Impurities5
General Considerations5.1
Major and Minor5.2
Nature and Consequences of5.3
Contaminants6
General Considerations6.1
Effects of contaminants6.2
Methods for Determining Impurities and Contaminants7

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:
biotechnology; contamination-medical materials/applications; data analysis-environmental; environmental control/fate; genetic examination; impurities; innocuous impurities; purity; purity/impurities/contaminants in biological drug products
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