Document Center is acquired by Nimonik

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.

Significance and 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.

Keywords

ICS Number Code 11.120.10 (Medicaments)

To find similar documents by ASTM Volume:

11.05 (Pesticides and Alternative Control Agents; Environmental Assessment; Hazardous Substances and Oil Spill Response)

11.06 (Biological Effects and Environmental Fate; Biotechnology)

14.02 (General Test Methods; Forensic Psychophysiology; Forensic Sciences; Terminology; Conformity Assessment; Statistical Methods; Nanotechnology; Forensic Engineering; Manufacture of Pharmaceutical Products)

To find similar documents by classification:

11.120.10 (Medicaments Including medical prescriptions and medicinal herbs)

This document comes with our free Notification Service, good for the life of the document.

This document is available in either Paper or PDF format.