Reactive Impurities in Excipients: Profiling, Identification and Mitigation of Drug–Excipient Incompatibility

@article{Wu2011ReactiveII,
  title={Reactive Impurities in Excipients: Profiling, Identification and Mitigation of Drug–Excipient Incompatibility},
  author={Yongmei Wu and Jaquan K Levons and Ajit S. Narang and Krishnaswamy Raghavan and V. Uma Maheshwara Rao},
  journal={AAPS PharmSciTech},
  year={2011},
  volume={12},
  pages={1248-1263}
}
Reactive impurities in pharmaceutical excipients could cause drug product instability, leading to decreased product performance, loss in potency, and/or formation of potentially toxic degradants. The levels of reactive impurities in excipients may vary between lots and vendors. Screening of excipients for these impurities and a thorough understanding of their potential interaction with drug candidates during early formulation development ensure robust drug product development. In this review… CONTINUE READING

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