Analytical Services
Methods that measure what they claim to measure, validated to ICH standards, and data that holds up when someone audits it.
Analytical work is where most regulatory questions actually land. A dossier gets queried on the impurity limits, the method specificity, the stability protocol - rarely on the chemistry itself. We resource it accordingly.
Services
Method development
Chromatographic and spectroscopic methods developed for specificity against the real impurity profile, not a theoretical one.
Method validation
Full validation to ICH Q2(R2) - specificity, linearity, accuracy, precision, range, detection and quantitation limits, robustness.
Method transfer
Comparative or co-validation transfer to or from your laboratory, with an agreed acceptance protocol up front.
Stability studies
Long-term, intermediate and accelerated studies under ICH Q1A(R2) conditions, plus photostability and forced degradation.
Impurity characterisation
Isolation, identification and structural elucidation of unknown impurities and degradants above the identification threshold.
Release testing
Routine identity, assay, related substances, residual solvents and physical testing against agreed release specifications.
Reference standards and impurities
Where a method needs a qualified impurity standard, we can synthesise and characterise it rather than leaving you to source it.
| Deliverable | What it includes |
|---|---|
| Impurity reference standard | Synthesis, purification, structural confirmation and a characterisation report |
| Working standard qualification | Assignment against a pharmacopoeial or primary standard with full documentation |
| Forced degradation study | Acid, base, oxidative, thermal and photolytic stress with mass balance assessment |
| Residual solvent method | Headspace GC method covering the solvents actually used in the route, validated to ICH Q3C |
Need a method validated or transferred?
Send the current method and the specification. We will tell you what it would take, and whether it is worth redeveloping instead.