Impurities & Reference Standards

This division supplies the reference materials that analytical teams need to identify and quantify impurities in APIs and finished products. It covers pharmacopoeial and process impurities, degradation products, metabolites, stable-isotope labelled compounds, nitrosamine drug-substance-related impurities (NDSRIs), genotoxic impurity standards and secondary working standards.

Standards are typically supplied in milligram quantities with a characterisation package that can include HPLC purity, 1H-NMR, mass spectrometry, IR and, where relevant, TGA or water content. Custom synthesis can be arranged for impurities that are not commercially listed, subject to feasibility. A COA and SDS accompany every shipment, and many items travel as non-hazardous small packs by courier.

Pharmaceutical QC and analytical development laboratories, regulatory affairs teams preparing ANDA, DMF or MAA submissions, CROs running method validation and forced degradation studies, and nitrosamine risk-assessment projects are the main users. Clear structural data and batch traceability matter more than volume here, so each standard is identified by chemical name, CAS number where assigned and molecular formula. Storage conditions and retest dates are stated on the label and COA so that labs can manage standards within their own qualification systems.