ICH guidelines — Q3A, Q3B, Q3C and M7 — call for tight identification, characterisation and quantification of impurities, often down to trace levels. Where catalogue standards do not exist or process-specific impurities emerge, custom synthesis is the only practical option. Our chemistry team was built precisely to deliver these hard-to-source compounds.
From process impurities and degradation products to metabolites, nitrosamines and genotoxic impurities — milligram quantities for research right through to gram-scale batches — every compound ships with a full Certificate of Analysis covering ¹H-NMR, HPLC, MS and KF data.
Request Impurity SynthesisIntermediate-stage impurities, coupling-reaction side-products, stereoisomeric by-products and other artefacts of the synthetic route.
Forced-degradation impurities arising from acid, base, oxidative, thermal and photolytic stress — supplied as stability-indicating reference standards.
Trace-level nitrosamines and nitrosamine-drug substance-related impurities synthesised in dedicated, high-control handling areas.
ICH M7-class mutagenic impurities prepared at trace levels with tight purity verification and dedicated safety-handling SOPs.
Phase I and Phase II drug metabolites: hydroxylations, glucuronides, sulfates, N-oxides, demethylations and the more challenging transformations beyond.
Enantiomers, diastereomers and epimeric pairs prepared for chiral method validation and stereochemistry control work.
An impurity standard is only as useful as the Certificate of Analysis behind it. Each compound that leaves our lab is supplied with a comprehensive analytical package: the data regulators want to see, formatted the way they expect to see it.
Full structural confirmation supported by interpreted spectra.
Chromatographic purity at ≥95% (typically ≥98%), supplied with a complete peak table.
ESI/APCI confirmation of the molecular ion alongside fragmentation analysis.
Karl Fischer titration covering water of hydration and residual moisture.
Impurity synthesis is not an add-on here; it is the discipline the company was founded around. Each of our chemists has worked on impurities that matter to ICH submissions.