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New Chemical Entities

New Chemical Entities (NCEs) are molecules or ions produced by chemical synthesis.

Thanks to over 30 years’ experience in analytical sciences and all our laboratories (Bioanalysis (PK/TK/Immuno), Bioassays, Biochemistry, Chromatography, Elemental Impurities, Mass Spectrometry, Microbiology, Molecular Biology, Protein Characterisation) on one site, Quality Assistance holds a unique position on the market.

Quality Assistance provides you with the scientific support and all the analytical technologies needed to support your drug development process including NCE characterisation, development and validation of analytical methods, stability studies and batch testing.

Our capabilities in this area are summarized in the following table:

Identity
Identification IR / TLC / (U)HPLC (UV, DAD, MS) / FTIR / UV/Vis
Composition (U)HPLC (DAD, MS)
Quantity & Product-related impurities
Chirality (U)HPLC (UV), Circular Dichroism, Capillary Electrophoresis (UV, LIF)
Assay

(U)HPLC (UV, DAD, RI, fluorescence, ELSD, CAD, conductimetry, PAD, MS)

GC (FID, ECD, MS)

Capillary Electrophoresis (UV, LIF)

ICP (OES, MS)

Titration

Dosage uniformity
Genotoxic impurities
Process-related impurities
Elemental impurities ICP (OES, MS)
Residual solvents (HS-)GC (FID, ECD, MS)
Water content Volumetric / Coulometric KF titration
Particulate matter Optical microscopy / Light obscuration / Imaging Particle Analysis
Physico-chemical properties
Particle size, shape and/or counting DLS / LD (Mastersizer) / Image Particle Analysis
pH, pKa, Log P, friability, hardness, disintegration, rheological properties, properties after reconstitution, osmolarity, zeta potential
Others tests
Dissolution Basket and Paddle dissolution testing
Microbiology Bioburden / Sterility (Filtration, Direct inoculation) / Preservative efficacy
Endotoxins Kinetic / End point
Packaging
Container Closure System Integrity Bubbling / Dye ingress / Microbial ingress
Cytotoxicity / Biological reactivity Cell-based assays / USP <87>

For Bioanalysis to be performed in Non-clinical and Clinical studies, Quality Assistance assists you from the method development and validation till study sample analysis with a full panel of techniques.


Pharmacokinetics & Toxicokinetics
Drugs, metabolites UPLC (MS/MS) / ICP (OES, MS)
Biomarkers ELISA / ECL (MSD) / UPLC (MS/MS)
Vehicles / Buffers (U)HPLC (UV, RI, DAD, fluorescence, ELSD, CAD, conductimetry, PAD) / ICP (OES, MS)

 

You can download the full table of NCE analysis here!

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