ASTM E 1298 : 1989 : R2000
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
Hardcopy , PDF
11-11-2014
English
01-01-2000
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 Use | 3 |
| Purity | 4 |
| General Considerations | 4.1 |
| Estimation of Purity | 4.2 |
| Impurities | 5 |
| General Considerations | 5.1 |
| Major and Minor | 5.2 |
| Nature and Consequences of | 5.3 |
| Contaminants | 6 |
| General Considerations | 6.1 |
| Effects of contaminants | 6.2 |
| Methods for Determining Impurities and Contaminants | 7 |
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.
Important note : All end users must be registered with an Account prior to user licenses being assigned.Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.