HPLC Method Development & Validation
At Averica, we understand your needs and tailor the method development to ensure your team makes the best decisions to achieve drug development milestones. Our scientists understand both the requirements of the method and the requirements of the compound. We define and evaluate key method parameters and identify critical quality attributes.
Analytical Method Development For All Product Development Phases
- Purity, potency (assay), and quantify specific impurities
- Stability indicating methods
- Chiral purity, chiral bioanalysis methods
- ICH Q11 support, e.g. for qualification of regulated starting materials (RSMs)
- Molecules with unique complexity or physical properties
- Modernization of legacy methods
- Development of product specification for commercial launch
Our services are tailored to your specific needs, offering the perfect solution for you and your molecules.
We recognize that our clients use many resources to bring a drug to market. Those resources: your internal team, CROs, and CMOs need methods that produce consistent, reliable data for their work. We develop analytical methods that are robust, transferable, reproducible, and designed to generate quality results.
Averica evaluates and carefully considers the performance parameters and critical quality attributes (CQA) when developing a method.
- System Suitability
- Evaluation of Limit of Detection (LOD) & Limit of Quantitation (LOQ)
- Linearity
- Accuracy
- Sample Stability
- Standard Stability
- Evaluation of Range
- Mass Balance
Instrument and Detective Systems
- SFC – Preparative & Analytical
- HPLC – Preparative & Analytical
- RP LC – Preparative & Analytical
- UPC^2
- UPLC
- GC
- ELSD
- MS
- CAD Detection
- PDA/UV
- NMR
- Accurate Mass MS