Development
Analytical development
Method development and validation built around ICH guidelines and pharmacopeial expectations, designed to be transferable to a QC laboratory.
Methods built for the regulated market
An analytical method is only as useful as the QC laboratory that has to run it every batch. We build stability-indicating methods with reproducibility, robustness and transfer in mind, from the first feasibility experiment to validated, locked-down release and stability methods.
- Method development for assay, related substances and dissolution
- Method validation per ICH Q2(R1)
- Forced degradation studies
- Method transfer protocols and reports
- Cleaning method development and validation
- Reference standard qualification
Equipment overview
- HPLC
- UPLC
- Gas chromatography
- Dissolution apparatus
- Particle size analyser
- UV-Vis spectrophotometer
- DSC / TGA
Method transfer in scope?
We routinely receive methods from sponsor laboratories and validate them under our quality system, or rebuild them to a stability-indicating standard if the gaps justify it.