At Acceledev, our dedicated Analytical Quality Control team provides full spectrum services and control in relation to analytical method development, validation, impurity characterization and quantification, release testing and stability studies. We are well equipped to perform the following activities as part of any API process development program.
- Analytical method development, validation and transfer in compliance with ICH guidelines
- In process control and release testing in compliance with Q7A requirements
- Detection of impurities or degradation products
- Impurity isolation and identification using prep-HPLC, LC-MS, GC-MS, FT-IR and NMR spectroscopy
- Genotoxic and elemental impurity method development and validation
- Reference standards characterization and qualification
