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

Author:

Wu Yongmei,Levons Jaquan,Narang Ajit S.,Raghavan Krishnaswamy,Rao Venkatramana M.

Publisher

Springer Science and Business Media LLC

Subject

Drug Discovery,Pharmaceutical Science,Agronomy and Crop Science,Ecology,Aquatic Science,General Medicine,Ecology, Evolution, Behavior and Systematics

Reference95 articles.

1. Moreton C. Functionality and performance of excipients in a quality-by-design world: part IV. Am Pharm Rev. 2010; Suppl. p. 18–21.

2. Narang AS, Rao VM, Raghavan K. Excipient compatibility. In: Qiu Y, Chen Y, Zhang GZ, Liu L, Porter W, editors. Developing solid oral dosage forms: pharmaceutical theory and practice. Burlington: Elsevier; 2009. p. 125–46.

3. Kibbe A. Handbook of pharmaceutical excipients. 3rd ed. Washington: American Pharmaceutical Association; 2000. p. 102–6.

4. Dubost DC, Kaufman MJ, Zimmerman JA, Bogusky MJ, Coddington AB, Pitzenberger SM. Characterization of a solid state reaction product from a lyophilized formulation of a cyclic heptapeptide. A novel example of an excipient-induced oxidation. Pharm Res. 1996;13(12):1811–4.

5. Katdare A, Chaubal M, editors. Excipient development for pharmaceutical, biotechnology, and drug delivery systems. New York: Informa Healthcare USA, Inc.; 2006. p. 100.

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