A synthetic route carries consequences for years: cost, yield, environmental burden and the impurities you will spend the rest of development controlling. We design better routes, and we make the impurity standards you need to control them.
Our team has a proven history with complex chemistry challenges and can support you in synthesizing challenging molecules by designing new, high-quality synthetic routes.
Route design and impurity control are the same problem seen from two sides. Every route produces its own family of process-related impurities, and those impurities have to be identified, characterized and controlled analytically before the process can be validated. A route chosen only for yield often turns out to be the expensive one, once the cost of controlling what it generates is counted.
The reverse also holds. Understanding which impurities a route produces, and why, frequently points directly at the step that should be re-designed — which is why we treat route scouting and impurity work as a single capability rather than two services.
The work runs from route design through to the reference standards your quality control laboratory will use.
Optimise and re-design your synthesis route with respect to synthesis time, environmental impact, yield and purification — including routes around problematic reagents or steps.
Increase the efficiency of your processes: fewer steps, better atom economy, simpler work-up, less solvent and less material lost to purification.
Isolate, characterize and synthesise process-related impurities for use as standard materials, including those present at levels too low to isolate preparatively.
Full structural characterization of unknown impurities and degradants, combining chromatographic separation, mass spectrometry and NMR.
Establish a proper control system and develop suitable analytical methods, so that each impurity has a method, a limit and a justification.
Synthesis of challenging intermediates, labelled compounds and reference materials that are not commercially available.
Route and impurity work is iterative by nature: each round of analysis changes what the chemistry should do next.
The existing synthesis is reviewed step by step for yield, selectivity, safety, cost, environmental burden and the impurities each step introduces.
Alternative routes are proposed and assessed on paper first, against the criteria that matter to your programme, before any laboratory time is committed.
The selected route is executed and optimised in the laboratory, with the critical steps examined in detail.
The impurity profile is mapped chromatographically across the route, and the origin of each significant impurity traced to a step.
Impurities are isolated preparatively where their level allows, and synthesised independently where it does not.
Each impurity standard is fully characterized, to the standard required for it to serve as a reference material.
Methods are developed to separate and quantify each impurity, and the control strategy is defined with you.
A technical-scientific report documents the route, the impurity profile and the control strategy; the synthesized standards are delivered with their characterization data.
Identifying an impurity present at a fraction of a percent requires separation and structural work of a different order from routine assay.
Deliverables are a detailed technical-scientific report and, where the project includes synthesis, the material itself — intermediates, reference standards or isolated impurities.
Usually yes. When an impurity is present at a level too low to isolate preparatively, independent synthesis is the route to a usable reference standard — and it has the advantage of confirming the proposed structure at the same time.
That is a common request. The work combines preparative separation, mass spectrometry and NMR, and where a crystal can be grown, single crystal diffraction settles the structure definitively.
Some of it, which is why the assessment is done on paper first. We would set out clearly what a route change would require before recommending it, so that the decision is made with the full cost visible.
Timelines depend on the scope agreed with you — the complexity of the chemistry, the scale required and the depth of characterization. We define the duration together with the project plan, before work begins, and keep you updated as results come in.
It depends on the stage and the objective. For development work we start from whatever is available and scale up as the process is established. We confirm the requirement when we scope the project.
Yes. Our facility is authorized to handle high-potency active pharmaceutical ingredients up to OEB5, and controlled substances under Ministry of Health authorization, under GMP certification issued by AIFA and following FDA inspection.
A detailed technical-scientific report: experimental conditions, raw analytical data, interpretation and conclusions. Where the project includes production, the synthesized material is delivered alongside the report.
Work starts only after a confidentiality agreement is in place. Routes, data and reports remain yours, and results are never shared or reused. We routinely handle undisclosed structures and proprietary processes.
Send us the current route or the chromatogram you cannot explain. We will come back with an assessment and a proposal.