期刊
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
卷 34, 期 2, 页码 255-264出版社
PERGAMON-ELSEVIER SCIENCE LTD
DOI: 10.1016/S0731-7085(03)00522-3
关键词
ion chromatography; universal method; active pharmaceutical ingredient; conductivity detection; counterion; method development; method validation
A universal method for quantitation of anionic substances in active pharmaceutical ingredients (API) during early development was developed using ion chromatography (IC). The method was developed to allow rapid characterization of APIs in support of early clinical studies The method parameters were chosen to allow quantitation of monovalent, divalent, and trivalent inorganic ions as well as monvalent and divalent carboxylic acids. These parameters were also chosen to ensure appropriate performance for regulated analyses using less than 10 mg of API per replicate. The method was applied to and validated for a range of anionic analytes in APIs of varying hydrophobicity to demonstrate applicability to various analyses encountered during early development of pharmaceuticals. (C) 2003 Elsevier B.V. All rights reserved.
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