Reactive impurities in large and small molecule pharmaceutical excipients – A review
| Autor: | Yonghua Taylor Zhang, Y. John Wang, Jackson D. Pellett, Kelly Zhang, Ajit S. Narang |
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| Rok vydání: | 2018 |
| Předmět: |
Potential impact
Chemistry 010401 analytical chemistry 030226 pharmacology & pharmacy 01 natural sciences Small molecule Combinatorial chemistry 0104 chemical sciences Analytical Chemistry 03 medical and health sciences 0302 clinical medicine Biopharmaceutical Impurity Posttranslational modification Drug product Elemental impurities Spectroscopy |
| Zdroj: | TrAC Trends in Analytical Chemistry. 101:34-42 |
| ISSN: | 0165-9936 |
| DOI: | 10.1016/j.trac.2017.11.003 |
| Popis: | Reactive impurities in excipients can cause drug product degradation or protein modification even at trace levels, and thus impact drug stability and quality. It is critical to understand the potential impact of these impurities during development in order to ensure a robust clinical and commercial product. In this article, we review reactive impurities in pharmaceutical and biopharmaceutical excipients for both small molecule and large molecule drugs. The common reactive impurities in excipients, including peroxides, aldehydes, organic acids, reducing sugars and elemental impurities are reviewed. Sources of these impurities, reactions and impact, analytical methods, and control and risk mitigation strategies are also discussed. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
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