LC/MS/MS & GC/MS Method Development / Validation

In order to keep our clients out in front of their development objectives, Frontage utilizes a streamlined, regimented approach to developing and validating bioanalytical methods. For most small molecules, Frontage has been highly successful in developing methods within one to two weeks of project start-up and validations complete within two to three weeks.

 

Frontage evaluates the following factors in developing robust bioanalytical methods:

  • Signal response

  • Chromatography conditions (column, mobile phase, flow rate, etc.)

  • Matrix effects and interference, sample preparations

  • Analyte affinities

  • Sensitivity (LLOQ & LOD)

  • Linearity range

  • Stability

The following method parameters are typically verified during validations:

  • Specificity

  • Sensitivity (LLOQ)

  • Extraction recovery

  • Linearity range (calibration curve)

  • Accuracy (intraday/interday)

  • Precision (intraday/interday)

  • Dilution integrity (above quantitation limit)

  • Bench-top stability

  • Freeze-thaw stability

  • Processed sample stability

  • Long term storage stability

  • Standard stock solution stability at RT

For a complete list of Frontage’s nonproprietary bioanalytical methods, please click here