Method Development & Validation
A botanical extract is not a simple matrix. Co-eluting compounds, isomers with near-identical mass, and matrix effects that shift with every harvest can make an off-the-shelf method unreliable. We develop analytical methods that are fit for the material in front of us, then validate them so the numbers hold up under scrutiny.
When you need a method built
- A new alkaloid, derivative, or marker compound with no published assay
- A compendial method that fails system suitability in your matrix
- Isomers or closely related structures that need baseline resolution
- A transfer from R&D to a QC laboratory that has to run it every day
- Trace-level quantitation of impurities, degradants, or process residues
Our approach
Scoping. We start with the question the method has to answer: identity, assay, impurity limit, or stability-indicating. That decision fixes the performance targets before any instrument time is spent.
Development. Column and mobile-phase screening, sample preparation optimization, detector selection, and forced-degradation studies to confirm the method separates what matters from what does not.
Validation. Full validation to ICH Q2(R2) principles: specificity, linearity, range, accuracy, precision (repeatability and intermediate), detection and quantitation limits, and robustness. Reference standards are qualified and documented.
Transfer. Written procedures, training records, and a comparative study so the receiving lab produces equivalent results on its own instruments.
What you receive
- A development report with the rationale behind every parameter
- A validation protocol, raw data, and a signed validation report
- A standard operating procedure written for routine use
- Reference-standard characterization and storage guidance
- Ongoing method maintenance and revalidation support when a change is made
Platforms
HPLC-UV/DAD, LC-MS/MS, headspace GC, ICP-MS, FTIR, and UV-Vis, supported by controlled-condition stability chambers for stability-indicating work.