The ICH guidelines — Q3A, Q3B, Q3C and M7 — require impurities to be identified, characterised and quantified precisely, frequently at trace level. When no catalogue standard exists, or a process throws up something specific to your route, bespoke synthesis is the only realistic answer. Our chemistry group was assembled to supply exactly these hard-to-source compounds.
Process impurities, degradation products, metabolites, nitrosamines and genotoxic impurities, in quantities from research milligrams up to gram-scale batches. Each compound leaves with a complete Certificate of Analysis carrying ¹H-NMR, HPLC, MS and Karl Fischer data.
Request Impurity SynthesisIntermediate-stage impurities, coupling side-products, stereoisomeric by-products and the other artefacts a synthetic route leaves behind.
Forced-degradation impurities from acid, base, oxidative, thermal and photolytic stress, supplied as stability-indicating reference standards.
Trace-level nitrosamines and nitrosamine drug substance-related impurities, prepared in dedicated high-control handling areas.
ICH M7-class mutagenic impurities made at trace level, with close purity verification and dedicated handling SOPs.
Phase I and Phase II metabolites — hydroxylations, glucuronides, sulfates, N-oxides, demethylations and the harder transformations past those.
Enantiomers, diastereomers and epimeric pairs made up for chiral method validation and stereochemical control work.
An impurity standard is worth exactly as much as the Certificate of Analysis behind it. Every compound leaving our laboratory carries a full analytical package — the data reviewers look for, set out the way they expect to find it.
Complete structural confirmation with interpreted spectra included.
Chromatographic purity at ≥95%, usually ≥98%, with the full peak table supplied.
ESI/APCI molecular-ion confirmation together with fragmentation analysis.
Karl Fischer titration for both water of hydration and residual moisture.
Impurity synthesis is not a sideline here — it is the discipline the company was built around, and every one of our chemists has worked on impurities that decided an ICH submission.