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:
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customised solutions in terms of analytical protocols and innovative technologies throughout non-clinical and clinical development.
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a full range of equipment in Chromatography, Mass Spectrometry, Biochemistry, Pharmaceutical Technologies and Microbiology, to meet all the challenges of developing and validating methods
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regulatory, scientific and technical excellence with a problem-solving approach
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compliance with all applicable EMA, FDA and ICH regulations
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GMP, GLP, GCLP/GCP environment
Your one-stop shop for analytical services
Outsource your analytical needs on one site for more efficiency including:
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Analytical development
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Validation of analytical methods as per ICH guidelines
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NCEs characterisation
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Stability studies
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Batch testing
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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) / (HS)-GC (FID, MS, ECD) / FTIR / UV-VIS spectrometry / TLC |
| Identification of unknown compounds |
Mass spectrometry (ESI-QTOF, APCI-QTOF)/ (U)HPLC (UV, DAD, MS, CAD, ELSD, fluorescence) / (HS)-GC (FID, MS, ECD) / FTIR / UV-VIS spectrometry / TLC |
QUANTITY
| Assay | (U)HPLC (UV, DAD, MS, CAD, ELSD, fluorescence) / (HS)-GC (FID, MS, ECD) / CE (UV, LIF), Titration |
| Dosage uniformity | (U)HPLC (UV, DAD, MS, CAD, ELSD, fluorescence) / (HS)-GC (FID, MS, ECD) / CE (UV, LIF), Titration |
PURITY / PROCESS-RELATED IMPURITIES
| Impurities | (U)HPLC (UV, DAD, MS, CAD, ELSD, fluorescence) / (HS)-GC (FID, MS, ECD) / CE (UV, LIF) |
| Chirality | (U)HPLC (UV, DAD, MS, CAD, ELSD, fluorescence) / (HS)-GC (FID, MS, ECD) / CE (UV, LIF) / CD / Polarimetry |
| Elemental impurities | ICP, ICP-MS |
| Residual solvents | (HS)-GC(FID, MS, ECD) / (U)HPLC (UV, MS) |
| Genotoxic impurities | (HS)-GC(FID, MS, ECD) / (U)HPLC (UV, MS) |
| Nitrosamines | GC-MS, LC-MS |
| Microbiology | Bioburden / Sterility |
| Endotoxins and Pyrogens | LAL (kinetic, end point) / MAT / rFC |
PACKAGING
| Container Closure System Integrity | Bubbling / Dye ingress / Microbial ingress |
| Leachables | (HS)-GC(FID, MS, ECD) / ICP (OES, MS) / (U)HPLC (UV, ELSD, CAD, MS) |
| Citotoxicity / Biological reactivity | Cell-based assays / USP <87> |
OTHER
| Dissolution tests | Paddles, Baskets (USP Apparatuses 1 and 2) |
| Rheological properties | Viscosimeter |
| Delivery system | To be discussed |
PHARMACOKINETICS / TOXICOKINETICS
| Drug and metabolite assays | UPLC-MS/MS (TSQ) / ICP-MS |
| Vehicle/Buffers | UPLC-UV / UPLC -MS/MS (TSQ) / ICP-MS |
IMMUNOGENICITY
| ELISA / Electrochemiluminescence (MSD) / Luminex / UPLC-MS/MS (TSQ) |
