NCEs (New Chemical Entities)
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 / MAT |
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
