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

✍ Scribed by Yongmei Wu; Jaquan Levons; Ajit S. Narang; Krishnaswamy Raghavan; Venkatramana M. Rao


Book ID
111768389
Publisher
Springer US
Year
2011
Tongue
English
Weight
410 KB
Volume
12
Category
Article
ISSN
1530-9932

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Estimation of impurity profiles of drugs
✍ Zs. Halmos; Cs. Szántay Jr.; J. Brlik; A. Csehi; K. Varga; P. Horváth; M. Kislak 📂 Article 📅 1996 🏛 Elsevier Science 🌐 English ⚖ 330 KB

Besides several known impurities in cimetidine, two additional compounds at levels below 0.1% were detected by ion-pair reversed-phase high-performance liquid chromatography (HPLC). The impurities were isolated from crude cimetidine using normal-phase preparative HPLC. 1H and 13C NMR and mass spectr