The purpose of the feasibility assessment is to determine whether the target analyte(s), in matrix, are good candidates for quantitative LC/MS/MS analysis. Typical feasibility projects require between two and 10 days to complete, depending on the complexity of the analysis. During feasibility we define the achievable lower limit of quantitation (LLOQ) and analytical range.
Below is a brief summary of the typical feasibility activities:
• Sponsor provides target analyte(s) with known purity in sufficient quantity (~100 mg)
• Internal standard candidates are investigated for suitability
• LC/MS/MS parameters are established for target analyte(s) and possible internal standard candidates
• Chromatographic parameters are established target analyte(s) and possible internal standard candidates
• Instrument sensitivity is evaluated with solutions of target analyte(s)
• Various extraction techniques are evaluated, including protein precipitation, liquid-liquid, and solid phase extraction
• Linearity is evaluated over the anticipated range
• Target analyte signal-to-noise ratio of extracts at the proposed LLOQ are measured and reported
