Custom synthesis of the standard you cannot find
A method validation often stalls on a single compound: an impurity that is in no catalogue, a degradant that only appears in stressed samples, or a labelled analogue nobody sells. Those are quoted from a structure. A CAS number is not required, and every lot is released with its own certificate of analysis.
| How it is quoted | Per project — the quotation states the pack size, the lead time and the documentation for that item |
|---|---|
| What we start from | SMILES, InChI, a drawing, a chemical name, or the parent drug substance plus the impurity designation. A CAS number is optional |
| Documentation | Certificate of analysis issued per lot, with the analytical basis for the assigned value stated on it |
| Where to send it | The form below, or [email protected] |
What we take on
If a compound is not in the catalogue, the question is whether it can be made — not whether it is listed.
- Non-compendial impurities — impurities outside the pharmacopoeial set, including those with no CAS number, no commercial reference material and no published route.
- Degradation products — compounds that appear in stressed or aged samples: oxidative, hydrolytic and photolytic degradants, and process impurities carried through from the route.
- Metabolites — phase I and phase II metabolites and their stable analogues, for identification, quantification or method validation.
- Labelled analogues — deuterated, 13C- and 15N-labelled standards, including labelled versions of compounds that exist unlabelled today.
- Nitrosamine and genotoxic impurities — nitrosamines, nitroso derivatives and other impurities controlled at trace level.
- Isolation and purification — when synthesis is not economic: isolation from your own mixture or from a related starting material, purified to a stated specification.
How a project runs
- Send the structure. SMILES, InChI, a drawing, a chemical name, or the parent drug substance plus the impurity designation.
- Feasibility and quotation. We check the route and the reference material, then quote the pack size, the lead time and the documentation you asked for.
- Synthesis with in-process checks. Intermediates are checked against the target specification, and you are told if the route has to change.
- Characterisation and dispatch. Content or purity is assigned per batch and recorded on the certificate of analysis issued for that lot.
What to put in the first message
- The compound — structure, name, CAS number if it has one, or the parent API and the impurity designation.
- Why you need it — identification, system suitability, quantification or method validation. This decides which documentation matters.
- The quantity — the mass or the number of vials, and whether it may be split over more than one batch.
- The specification — any fixed purity, salt form, counter-ion or concentration your method requires.
- The date and destination — when the material has to be in your hands, and the destination country.
If you hold the synthetic route, an impurity profile or a reference spectrum, mention it — it shortens the feasibility step considerably.
Start a custom request
Questions we are asked before a project starts
Can you make an impurity that is not in the catalogue?
Yes. Non-compendial impurities, degradation products, metabolites and labelled analogues are quoted from a structure, whether or not the compound has a CAS number or appears in any commercial catalogue.
What do you need in order to quote?
The structure — SMILES, InChI, a drawing or a chemical name — together with the purpose it is needed for, the quantity, any fixed specification and the date you need it by. A CAS number is helpful but not required. If you already hold a route, an impurity profile or a reference spectrum, send it: it shortens the feasibility step.
How long does a custom project take?
It depends on the route and on what reference material already exists. The lead time is stated for the specific pack size in the written quotation, and you are told if it changes.
How is a custom batch characterised and released?
Content or purity is assigned per batch, and both the value and the analytical basis for it are recorded on the certificate of analysis issued for that lot.
Can you isolate a compound from material we already hold?
Yes. Isolation and purification from your own mixture, or from a related starting material, can be quoted when that is more practical than synthesis.
How is custom work priced?
Per project rather than per catalogue entry, so the figure depends on the route, the quantity and the documentation required. We do not publish prices and we do not send a price list: quotations are prepared per enquiry.