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Service Centre

Chromatography, LC and GC

Hovione FarmaCiencia SA

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

www.hovione.com

Contact person's name

António Ramos

Contact person's e-mail

aramos@hovione.com

Contact person's telephone

219829298

Services

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.

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