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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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Standard Guide for Determination of Purity, Impurities, and Contaminants in Biological Drug Products
Hardcopy , PDF
11-11-2014
English
01-01-2000
Important note : Users cannot be edited or removed once added to your Multi user PDF.| Committee |
E 48
|
| DocumentType |
Guide
|
| Pages |
3
|
| ProductNote |
Reconfirmed 2000
|
| PublisherName |
American Society for Testing and Materials
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
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.
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| ASTM F 2027 : 2016 | Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products |
| ASTM F 2212 : 2011 | Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs) |
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