NCEs (New Chemical Entities)

Our added value brings together a sound expertise in the analytical development of small molecules along with state-of-the-art facilities and equipment, all on one site.

Quality Assistance is your analytical partner providing customised solutions in terms of analytical protocols and innovative technologies throughout non-clinical and clinical development.

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

  • Bioanalytical services

GENERAL QUALITY
Appeareance  
pH / osmolarity  
Water content / residual moisture KF titration (volumetric, coulometric, oven)
Particulate matter Optical microscopy / Light obscuration / Imaging Particle Analysis
Properties after reconstitution  
IDENTITY
Identification tests Mass spectrometry (ESI-QTOF, APCI-QTOF)/ (U)HPLC (UV, DAD,
MS, CAD, ELSD, fluorescence) / GC (FID, MS) / FTIR / UV-VIS
spectrometry / TLC
Identification of unknown
compounds
Mass spectrometry (ESI-QTOF, APCI-QTOF)/ (U)HPLC (UV, DAD,
MS, CAD, ELSD, fluorescence) / GC (FID, MS) / FTIR / UV-VIS
spectrometry / TLC
QUANTITY
Assay (U)HPLC (UV, DAD, MS, CAD, ELSD, fluorescence) / GC (FID, MS) /
Dosage uniformity CE (UV, LIF), Titration
Dosage uniformity (U)HPLC (UV, DAD, MS, CAD, ELSD, fluorescence) / GC (FID, MS) /
Dosage uniformity CE (UV, LIF), Titration
PURITY / PROCESS-RELATED IMPURITIES
Impurities (U)HPLC (UV, DAD, MS, CAD, ELSD, fluorescence) / GC (FID, MS) /
CE (UV, LIF)
Chirality (U)HPLC (UV, DAD, MS, CAD, ELSD, fluorescence) / CE (UV, LIF) /
CD / Polarimetry
Elemental impurities ICP, ICP-MS
Residual solvents GC (FID, MS) / (U)HPLC (UV, MS)
Genotoxic impurities GC (FID, MS) / (U)HPLC (UV, MS)
Nitrosamines GC-MS, LC-MS
Microbiology Bioburden / Sterility
Endotoxins and Pyrogens LAL (kinetic, end point) / MAT / rFC
PACKAGING
CCIT Bubbling / Dye ingress / Microbial ingress
Leachables GC (FID, ECD, MS) / ICP (OES, MS) / (U)HPLC (UV, ELSD, CAD, MS)
Citotoxicity / Biological reactivity Cell-based assays / USP <87>
OTHER
Dissolution tests Paddles, Baskets (USP Appartuses 1 and 2)
Log P, pKA HPLC (UV)
Rheological properties Viscosimeter
Delivery system To be discussed
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