| Autor: |
Tolle JC; Abbott Global Pharmaceutical Process R&D, Dept. R450, Bldg R13, 1401 Sheridan Road, North Chicago, IL 60064-6290, USA., Becker CL, Califano JC, Chang JL, Gernhardt K, Napier JJ, Wittenberger SJ, Yuan J |
| Jazyk: |
angličtina |
| Zdroj: |
Advances in experimental medicine and biology [Adv Exp Med Biol] 2009; Vol. 611, pp. 595-6. |
| DOI: |
10.1007/978-0-387-73657-0_259 |
| Abstrakt: |
Understanding impurity rejection in a drug substance crystallization process is valuable for establishing purity specifications for the starting materials used in the process. Impurity rejection has been determined for all known ABT-510 impurities and for many of the reasonable & conceivable impurities. Based on this study, a very high purity specification (e.g., > 99.7%) can be set for ABT-510 with a high level of confidence. |
| Databáze: |
MEDLINE |
| Externí odkaz: |
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