Synthetic small molecules
As the pharmaceutical landscape evolves, synthetic small molecules continue to play a critical role in drug development. Their well-characterized structures, scalable manufacturing processes, and broad therapeutic applications, from oncology and CNS disorders to anti-infective treatments, highlight their enduring relevance across therapeutic innovation.
The trusted foundation of drug development
Transforming chemical structures into safe and effective medicines requires more than scientific innovation. It calls for analytical precision, deep expertise and seamless integration from early development to market release.
At Quality Assistance, our experts design and execute tailored analytical strategies that ensure the quality, safety, and efficacy of your small molecule candidates across non-clinical and clinical phases. From method development to stability studies, release testing and bioanalysis, we provide continuous, integrated support that helps streamline your path to successful commercialisation.
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Analytical challenges we help you solve
Synthetic small molecules continue to play a vital role in treating a wide range of diseases. At Quality Assistance, we help you address the critical analytical questions that ensure product quality and patient safety.
Because many of these compounds, including highly potent and cytotoxic molecules, require stringent safety measures, our dedicated infrastructure and procedures guarantee their safe handling and analytical testing within a controlled GxP environment.
This includes detecting and quantifying impurities, such as genotoxic impurities and process-related species, even at trace levels. It means demonstrating batch-to-batch consistency through robust assay and identification methods. Your analytical strategy must also cover degradation pathways, photostability and long-term stability under ICH conditions.
Here is the full range of analytical techniques we offer to support your development:
| Identification tests | MS (ESI-QTOF, APCI-QTOF) / (U)HPLC (UV, DAD, MS, CAD, ELSD, fluorescence) / GC (FID, MS) / FTIR / UV-VIS spectrometry / TLC |
|---|---|
| Identification of unknown compounds | MS (ESI-QTOF, APCI-QTOF) / (U)HPLC (UV, DAD, MS, CAD, ELSD, fluorescence) / GC (FID, MS) / FTIR / UV-VIS spectrometry / TLC |
| 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 |
| 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 (OES, 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 |
| Container Closure System Integrity | Bubbling / Dye ingress / Microbial ingress |
| Leachables | (HS)-GC(FID, MS, ECD) / ICP (OES, MS) / (U)HPLC (UV, ELSD, CAD, MS) |
| Cytotoxicity / Biological reactivity | Cell-based assays / USP <87> |
| Break Loose and Glide Force (BLGF) for prefilled syringes |
| Dissolution tests | Paddles, Baskets (USP Apparatuses 1 and 2) |
| Rheological properties | Viscosimeter |
| Delivery system | To be discussed |
Integrated analytical services for small molecule development
We offer a comprehensive suite of analytical and bioanalytical services to support your small molecule drug development, from early-stage characterisation to late-phase clinical trials. Our capabilities include identity, purity, quantification and biomarker analysis, all under GxP compliance and aligned with EMA, FDA, and ICH guidelines. Our platform integrates advanced instrumentation for robust method development and validation:
- Mass spectrometry: LC-MS/MS, GC-MS, QTOF for identity confirmation, assay, impurity profiling, and metabolite analysis
- Chromatography & Spectroscopy: (U)HPLC, GC, CE, UV, FTIR for assay, content uniformity, degradation and impurity testing
- Elemental Analysis: ICP-MS and ICP-OES for elemental impurity quantification
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Bioanalytical expertise
Our bioanalytical services provide full support across all phases of drug development, from early PK/TK studies to late-phase clinical trials.
We develop and validate methods under GLP, GCLP, and GCP standards, ensuring regulatory compliance. Small molecule drugs and their metabolites are quantified in a wide range of biological matrices, including plasma, serum, cerebrospinal fluid, brain homogenates and tissues, using highly sensitive and specific techniques such as UPLC-MS/MS and ICP-MS
We also offer biomarker analysis using ELISA, MSD, Luminex and LC-MS/MS platforms. Our team ensures accurate data reporting and direct transfer to your database.
Why innovators choose us
By selecting us as your strategic partner, you benefit from:
- Four decades devoted to small molecules: with 43 years of expertise, our knowledge spans the entire history of modern drug development. This in-depth, cumulative experience translates directly into the development of fit-for-purpose methods to generate reliable data even for the most complex small molecules.
- One-site continuity: all CMC and bioanalytical services are performed on a single GxP-compliant site in Belgium, ensuring scientific consistency, full traceability, and fast turnaround.
- Regulatory alignment: our methods are designed to meet EMA, FDA and ICH expectations across all development phases, from preclinical to commercialisation.
- Custom-fit strategies we adapt to your molecule, formulation and clinical phase
- Broad technical coverage: from impurity profiling to dissolution testing and LC-MS/MS bioanalysis, we cover the full spectrum of synthetic small molecule needs.
- Dedicated facilities for the safe manipulation and testing of highly potent and cytotoxic compounds
Move forward with clarity
Synthetic small molecules are essential to modern medicine and to patients worldwide. Partner with us to bring your drug product to patients, with confidence thanks to our tailored analytical solutions.