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Extractables and Leachables as Container Closure Considerations in Lyophilization
| Content Provider | Scilit |
|---|---|
| Copyright Year | 2016 |
| Description | INTRODUCTION The suitability of the container closure systems (CCS) for lyophilized pharmaceutical and biological products can be enhanced using the principles of quality by design (QbD) and employing risk management tools. Leachables, chemical constituents that migrate from packaging materials into the pharmaceutical product under normal conditions, can be minimized or eliminated when components are considered early in the pharmaceutical development process. A set of experiments can be designed to facilitate material selection by profiling materials for extractables using exaggerated conditions and assessing the impact to the pharmaceutical product and ultimately patient safety. Book Name: Freeze-Drying/Lyophilization of Pharmaceutical and Biological Products |
| Related Links | https://www.taylorfrancis.com/chapters/edit/10.3109/9781439825761-20/extractables-leachables-container-closure-considerations-lyophilization-diane-paskiet-fran-degrazio |
| Ending Page | 438 |
| Page Count | 12 |
| Starting Page | 427 |
| DOI | 10.3109/9781439825761-20 |
| Language | English |
| Publisher | Informa UK Limited |
| Publisher Date | 2016-04-19 |
| Access Restriction | Open |
| Subject Keyword | Book Name: Freeze-Drying/Lyophilization of Pharmaceutical and Biological Products Pharmacology and Pharmacy Extractables Constituents Introduction |
| Content Type | Text |
| Resource Type | Chapter |