Custom Method Development
Designing fit-for-purpose analytical methods from scratch based on your matrix, analytes and performance requirements — column and mobile phase selection, gradient design, detector settings and sample preparation.
Method Development
Analytical method development, validation and transfer
Scientora's analytical group designs GC and HPLC methods that reproduce — between analysts, between instruments and between sites — and documents them so they survive an audit.
What we do
Five services, from a blank method to a trained analyst.
Clients bring us in for one of three reasons: a method that will not reproduce between analysts, a backlog that keeps growing because runs have to be repeated, or an upcoming audit with documentation that will not hold. In each case the work is the same — take the analysis apart, find where the variability enters, and rebuild the procedure so it survives being handed to someone else.
Method Validation
Full validation to the relevant guideline (ICH, USP, AOAC and others) confirming accuracy, precision, linearity, LOD and LOQ, specificity, range and robustness, delivered as a complete validation report.
Method Optimization & Transfer
Improving existing methods for better sensitivity, shorter run time or greater robustness, and transferring them between instruments, models or laboratories with documented acceptance criteria.
Application-Specific Methods
Tailored methods for pharmaceuticals, environmental samples, food and beverage, petrochemicals and other matrices — built around the interferences that particular matrix actually presents.
Documentation & Training
Complete method documentation plus operator training, on your instruments and in your laboratory, so your team can run the method reliably in-house from day one.
Qualification Support
IQ, OQ and PQ documentation support for GC, GC-MS and HPLC systems, plus system suitability criteria and out-of-specification investigation and root-cause review.
Techniques
Where we work
Chromatography is our home ground. If your analysis sits outside this list, tell us anyway — we will say plainly whether it is ours or whether you need a specialist elsewhere.
HPLC — UV, DAD, RID, FLD
UHPLC — fast gradient methods
GC — FID, TCD, ECD
GC-MS — single quadrupole
Headspace & residual solvents
Sample prep — SPE, LLE, digestion
Common questions
Method development, answered.
Do we have to be a construction client to use this service?
No. Method development is a standalone service line. Many clients come to us only for analytical work and never buy a bench from us.
Which guidelines do you validate to?
ICH Q2 for pharmaceutical work, USP General Chapters where a compendial method applies, and AOAC for food and agricultural matrices. We agree the applicable guideline in the scope before we start so the validation package matches what your auditor expects.
Can you transfer a method to our instruments?
Yes. Method transfer between instruments, between models from different manufacturers, and between sites is a routine part of the work. The transfer package includes acceptance criteria, the comparative data and the signed transfer report.
What does an engagement cost?
Scope drives price. A single method review is a small fixed-fee engagement; a full development and validation programme for a new product is quoted per method. Send us the matrix, the analytes and the guideline and we will scope it.
Request a quote
Tell us the matrix and the analyte. We'll scope the method.
Send the sample matrix, the analytes, the guideline you have to satisfy and any existing method that is not behaving. We will come back with a scope, a timeline and a fixed price.