Method Development & Validation
Analytical method development and validation is a key part of ensuring your methods are good for their intended purpose throughout the developmental life cycle. Curia offers a phase appropriate approach to ensure that the correct level and development and validation is applied depending on the phase of development your product is in. Validations are performed in compliance with ICH and USP guidelines.
Curia’s expert team of analytical chemists across our network of laboratories has a extensive experience in developing a wide range of methods:
- HPLC/UPLC stability indicating methods
- Residual solvent methods
- Enantiomeric purity determination by Chiral HPLC
- PGI (potential genotox impurities) by GC-MS and HPLC-MS
- Nitrosamines
- Cleaning methods
- Ion-Chromatography
- Particle size methods
- ID by MS, NMR or XRPD
- Polymorph limit and quantifying methods by XRPD