TECHNIQUES
Ultra-High Performance Liquid Chromatography (UHPLC) is a core competence at Valentia Analytical enabling use of sub-2 micron particle columns to achieve maximal resolution. This is in comparison to traditional high performance liquid chromatographic systems that could not. That being said, methods may come in requiring the specific use of HPLC. The specific system we have enables use of either mode, in UHPLC or HPLC. Collective years of expertise have been forged with different chromatographic modes including reversed-phase, size-exclusion, ion-exchange, and affinity chromatography.
Active Pharmaceutical Ingredient (API) content, purity, impurity; raw material identification, drug content, drug load, characterization of degradation products, peptide mapping of proteins for identity.
UPLC/HPLC
Reversed-Phase Chromatography
Plasmid DNA topoisomeric homogeneity for open chain, supercoiled, and linear forms; protein charge heterogeneity.
UPLC/HPLC
Ion Exchange Chromatography
Protein aggregation, Protein degradation, Plasmid DNA multimer analysis.
UPLC/HPLC
Size Exclusion Chromatography
IgG titer content using protein A.
HPLC Affinity Chromatography
Drug release testing per USP<724> using USP Apparatus 2
Drug Release
Compendial testing per USP <791> pH, EP 2.2.2. <Degree of Coloration of Liquids>