Isolation and identification of impurity/degradant of APIs and DPs to support process optimization and regulatory filing.
Impurity Isolation
Isolation of impurities in starting materials, intermediates, APIs and drug products using efficient separation techniques including preparative HPLC and SFC
Isolation of the degradation products of APIs from forced degradation studies
Impurity Structure Elucidation
Structure elucidation of isolated impurities by acquisition and interpretation of comprehensive 1D/2D NMR, MS and IR data
Fast purity determination of raw materials, intermediates, APIs and synthetic impurities by quantitative NMR (QNMR)
Impurity identification and analysis based on customers’ needs