Service Centre category(ies)
Biochemical / Chemical / Structural Analysis
Description of the Service Centre
The Chromatography Service integrates multidimensional and hyphenated technologies to perform advance Method Development, Method Validation, In process Control and Final product Release analysis, Standard Qualification and Requalification, Impurity Screening and Characterization. All services provided within the Chromatography area are all under current Good Manufacturing Practices and using Full Qualified Analytical Systems.
Service Centre web address
Contact person's name
António Ramos
Contact person's e-mail
aramos@hovione.com
Contact person's telephone
219829298
Service
Method Development
Available for external use?
Yes
Comments
Method development including columns screening, selection of best mobile phases, product dissolution conditions, impurity separation and peak purity; Use of forced degradation conditions for impurity method development.
Service
Method Validation
Available for external use?
Yes
Comments
Full ICH Chromatographic methods validation. Available technologies: HPLC-UV, HPLC-PDA, LC/MS/MS, Head Space-GC-FID; GC/MS; UPLC.
Service
Standard Qualification
Available for external use?
Yes
Comments
Primary and secondary standards can be qualified according to specific or general protocols complying with health authorities requirements; Storage, stock and requalification is managed by the Chromatography Lab.
Service
Genotoxic Impurities Method Develpment and Validation
Available for external use?
Yes
Comments
Using advanced LC/MS/MS technology low levels of Genotoxic or Potential Genotoxic impurities can be determined and methods validated according to ICH guidlines.
