Development and application of a universal method for quantitation of anionic constituents in active pharmaceutical ingredients during early development using suppressed conductivity ion chromatography.
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 10mg 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.
Cassidy
Scott A
SA
Analytical Development Department, Pfizer Corp., 4901 Searle Parkway, Skokie, IL 60077, USA. scottcassidy@comcast.net
Demarest
Charles W
CW
Wright
Paul B
PB
Zimmerman
Jayne B
JB
D000838:Anions / Q000032:analysis* / Q000737:chemistry / Q000592:standards; D002852:Chromatography, Ion Exchange / Q000379:methods; D004364:Pharmaceutical Preparations / Q000032:analysis* / Q000737:chemistry / Q000592:standards; D015203:Reproducibility of Results; D013678:Technology, Pharmaceutical / Q000379:methods* / Q000592:standards
D000838:Anions; D004364:Pharmaceutical Preparations