Impurity testing is crucial to provide purity, safety and quality control for APIs and drug products. Pharmaceutical impurities may come from different sources, such as: starting materials, reagents, solvents, intermediates, degradation products and excipients and can be both of organic and inorganic origin. Due to the fact that impurities are present at trace levels in complex sample matrixes, its testing requires highly specific methods.
Selvita’s GxP compliant laboratory facilities deliver comprehensive analytical support against impurity profiling, identification, certification – in compliance with ICH guidelines. Our scientists have broad experience in suitable method development and validation, especially at demanding low detection levels.
- Custom method development and validation
- Product and API specific methodology
- Qualitative/quantitive analysis
- Organic compounds identification