Impurity standards

Certified Drug Impurity Reference Standards for Pharmaceutical Safety and Regulatory Compliance

Clinivex supplies a comprehensive range of high-purity pharmaceutical impurity standards meticulously characterized for impurity identification, quantification, and threshold validation throughout the drug development lifecycle. Our catalog encompasses structural analogs, enantiomeric impurities, starting material residues, forced degradation products, and nitrosamine impurities including NDMA, NDEA, and other N-nitrosamine compounds subject to evolving FDA and EMA scrutiny. For laboratories requiring dedicated N-nitrosamine characterization, our nitrosamine impurity standards portfolio provides precisely assigned concentrations verified through validated LC-MS/MS and GC-TEA methods. Each drug impurity reference standard is synthesized and verified using NMR, HPLC, LC-MS, and IR spectroscopy, ensuring chemical identity and concentration accuracy that laboratories can rely on during both early-phase research and late-stage regulatory filings.

As a leading impurity reference standards supplier trusted by pharmaceutical teams across the USA and international markets, Clinivex delivers every standard with a detailed Certificate of Analysis (CoA) that includes structural confirmation, assigned purity values, uncertainty data, and storage recommendations aligned with USP, EP, and JP compendial requirements. Our materials are manufactured and qualified in compliance with GMP and ISO 17025 frameworks, providing the evidentiary documentation essential for IND, NDA, and ANDA submissions. Our experienced technical specialists are available to help you identify the right impurity standards for your specific drug substance or drug product matrix, ensuring your analytical methods are robust, defensible, and audit-ready. For related active compound testing, browse our API reference standards catalog covering primary and secondary drug substance characterization.