Method Development San Diego, CA

Chromatographic Conditions
  • Column chemistry, particle size, and dimensions
  • Mobile‑phase composition, pH, and gradient profiles

Detector & MS Settings
  • Wavelength selection, gain settings, and response factors
  • MS ionization mode, collision energies, and dwell times

Flow‑through Testing
  • Inject a series of standards to fine‑tune retention, resolution, and peak shape
  • Use design‑of‑experiments (DoE) to systematically explore variables and interactions

• Robustness Checks: Deliberately vary temperature, flow rate, and pH to ensure method stability
• Calibration & Linearity: Establish calibration curves across the intended concentration range with replicate injections
• Limit of Detection (LOD) & Quantitation (LOQ): Determine the lowest levels you can reliably detect and quantif

Full Validation Package
  • Accuracy, precision, specificity, and carryover studies
  • System suitability criteria and acceptance thresholds

Standard Operating Procedures (SOPs)
  • Step‑by‑step instructions for sample prep, instrument setup, and data processing
  • Troubleshooting tips and maintenance reminders

Final Report
  • Detailed method description, validation data, and recommended QC checks
  • Ready‑for‑audit documentation, including raw data and signed checklists