4 Method development for pharmaceutical analysis

摘要: Abstract Development of capillary electrophoresis (CE) methods to be applied in late phase pharmaceutical development for low-molecular-weight compounds is discussed great detail. The important message that all stakeholders the analytical methods, i.e., lab and receiving quality control (QC) labs, need collaborate closely generate a test method description well written, easy apprehend, simple perform, will result robust reliable performance within QC environment. Indeed, are developed transference labs supposed last entire product lifetime. Especially CE there additional demands satisfied. Thorough knowledge skills CE-specific applications, which may unlike typical chromatographic expertise, required. strategies specifically applicable with practical examples. Although approaches proposed intended products, they can easily early also high-molecular-weight compounds.