Drug product development
Analytical testing
At Xedev, we provide end to end analytical drug development including development, method verification, qualification and validation, QC batch release, and ICH-compliant stability studies to support your drug product journey from early formulation development through clinical manufacturing.
Our laboratories are equipped to deliver both R&D analytical testing for early-stage development and GMP-compliant testing for Phase I and II clinical batches.
Our analytical experts work closely with our formulation and process development teams, enabling efficient collaboration, fast decision-making, and the flexibility needed to ensure timelines are met.
Analytical capabilities for R&D, quality control and release testing
Solubility and Dissolution
- Solubility studies
- Dissolution testing (in biorelevant media)
Chromatographic capabilities
- Assay
- Impurities and related substances
- Forced degradation
- Content uniformity
- Residual solvent analysis
Moisture analysis
- Karl Fischer titration
- Loss-on-drying
Microbiology
- Microbiological testing (e.g. TAMC, TYMC...)
Physicochemical characterization
- Particle size distribution
- Morphology and shape
- DVS (Hygroscopicity)
- Powder flow properties
- Compressibility
Solid-state characterization
- XRPD
- mDSC
- FTIR
- Raman
Oral solid dosage testing
- Disintegration
- Tablet hardness
- Tablet friability
Stability studies
We conduct ICH-compliant stability studies to evaluate the stability profile and shelf life of your drug product under long-term, accelerated, and stress conditions.
