Regulatory guidelines (ICH Q3A, Q3B, Q3C, M7) demand stringent identification, characterisation and quantification of impurities — even at trace levels. When commercial standards don't exist or unique process-related impurities arise, custom synthesis is the only path forward. Drug Logix India's chemistry team is built around delivering exactly these hard-to-source standards.
We synthesise process impurities, degradation products, metabolites, nitrosamines and genotoxic impurities — from milligram research quantities to gram scale — every compound supplied with a full Certificate of Analysis including ¹H-NMR, HPLC, MS and KF data.
Request Impurity SynthesisIntermediate-stage impurities, side-products of coupling reactions, stereoisomeric by-products, and other synthetic route artefacts.
Forced-degradation impurities from acid, base, oxidative, thermal and photolytic stress — stability-indicating reference standards.
Trace-level nitrosamine and nitrosamine-drug substance-related impurities synthesised under dedicated high-security handling protocols.
ICH M7-class mutagenic impurities synthesised at trace levels with stringent purity verification and safety-handling SOPs.
Phase I and Phase II drug metabolites — hydroxylations, glucuronides, sulfates, N-oxides, demethylations and beyond.
Enantiomers, diastereomers and epimeric pairs for chiral method validation and stereochemistry control studies.
The value of an impurity standard is in its Certificate of Analysis. Every compound we ship carries a comprehensive analytical package — the data regulators want to see, presented the way they want to see it.
Full structural confirmation with interpreted spectra.
Chromatographic purity ≥95% (typical ≥98%) with peak table.
ESI/APCI confirmation of molecular ion and fragmentation.
Karl Fischer titration for water of hydration / residual moisture.
Impurity synthesis isn't a side-service at Drug Logix India — it's what we built the company around. Every chemist here has worked on ICH-submission-critical impurities.