NCEs

To meet your analytical needs, Quality Assistance provides you with scientific and technical support for the development of your New Chemical Entities. Our added-value brings together a sound expertise in small molecules analytical development with state-of-the-art facilities and equipment, all on one site.

Your analytical partner providing:

  • customised solutions in terms of analytical protocols and innovative technologies throughout non-clinical and clinical development.

  • a full range of equipment in Chromatography, Mass Spectrometry, Biochemistry, Pharmaceutical Technologies and Microbiology, to meet all the challenges of developing and validating methods

  • regulatory, scientific and technical excellence with a problem-solving approach

  • compliance with all applicable EMA, FDA and ICH regulations

  • GMP, GLP, GCLP/GCP environment

Your one-stop shop for analytical services

Outsource your analytical needs on one site for more efficiency including:

  • Analytical development
  • Validation of analytical methods as per ICH guidelines
  • NCEs characterisation
  • Stability studies
  • Batch testing
  • Bioanalysis
IDENTITY
Identification IR / TLC / (U)HPLC (UV, DAD, MS) / FTIR / UV/Vis
Composition (U)HPLC (DAD, MS)
QUANTITY AND 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
OTHER 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>
Download the product sheet for more information