912 reference standards & impurities catalogued · custom synthesis on request
Synthesis Analytics Private Limited
We synthesise, characterise and supply pharmaceutical reference standards, API impurities and working standards — each one released with the analytical dossier your filing needs.
Compounds catalogued against the monographs your methods already reference
What we do
Everything we ship is built to survive scrutiny — from a routine QC release to a regulator asking where a peak came from.
Identified, unidentified, degradation and process-related impurities synthesised to pharmacopoeial identity for method validation and regulatory risk assessment.
Fully characterised primary reference standards and cost-efficient working standards, each released against a documented assay with a complete analytical dossier.
Route scouting, process development and scale-up for molecules that are not on the shelf — including labelled analogues, metabolites and difficult intermediates.
Structure elucidation, impurity profiling and method development supported by an instrument suite built for trace-level characterisation.
The catalogue
Filter by therapeutic area or jump straight to a parent molecule. Every entry carries its CAS number where one has been assigned.
Frequently requested molecules
Inside the lab
Synthesis, purification and characterisation happen under one roof. A compound never leaves the building between being made and being proven — which is why the data behind a certificate is always ours to produce.
From the shelf
Catalogue items are typically dispatched within three to five working days, with the full documentation pack.
How it works
A predictable five-step route, with a committed date agreed before any chemistry starts.
Send the compound name, CAS number or the chromatogram you are trying to explain. We confirm availability, scale and lead time — usually within one working day.
For non-catalogue compounds our chemists propose a synthetic route, flag the risks and agree a milestone plan before work begins.
Synthesis, work-up and purification to the agreed purity specification, with in-process checks at each stage.
Identity and purity established by NMR, mass spectrometry, chromatography and IR, and the analytical dossier compiled.
Batch released against the characterisation protocol, packed under inert conditions where required, and shipped with full documentation.
Documentation
A standard is only as good as the data behind it. Each batch is released against a documented characterisation protocol, and the raw data travels with the compound.
Assigned potency, identity confirmation, chromatographic purity, water content and re-test date.
¹H and, where structurally required, ¹³C and 2D spectra with full peak assignment.
LC-MS or HRMS confirming molecular ion and, where relevant, fragmentation pattern.
Chromatographic purity trace with the method conditions used to generate it.
Functional group confirmation supporting the assigned structure.
GHS-format MSDS covering handling, storage and transport classification.
Services
When the compound does not exist yet, or the method will not resolve, this is where our chemists come in.
Questions
Still unsure? A two-line email usually settles it faster than a form.
A primary reference standard is characterised in full and its potency assigned by mass balance without reference to another standard. A working standard is qualified against that primary standard and is intended for day-to-day routine analysis, which makes it considerably more economical for high-volume QC use.
Every vial ships with a Certificate of Analysis, an MSDS and the supporting spectral data — NMR, mass spectrum, chromatographic purity trace and IR. Additional raw data can be supplied on request for regulatory submissions.
Yes. Roughly a third of what we make each year is custom. Send the structure, the CAS number or the analytical data you have, and our chemists will come back with a feasibility assessment, an indicative timeline and a quotation.
Catalogue standards are typically supplied in 10 mg, 25 mg, 50 mg and 100 mg pack sizes. Larger quantities, up to multi-gram and kilo scale for intermediates, are available on request.
Catalogue items held in stock generally dispatch within 3–5 working days. Custom synthesis depends entirely on route complexity — most projects fall between 4 and 12 weeks, and we commit to a date before starting work.
Yes. If a regulator raises a query on an impurity we supplied, we will provide the supporting characterisation data and, where needed, a technical narrative to support your response.
Next step
Send us the compound name, the CAS number, or simply the chromatogram you are trying to explain. Our chemists will come back with availability, scale and a realistic timeline.
