Drug metabolism

Structurally Confirmed Drug Metabolite Reference Standards for Bioanalysis, Safety Assessment, and ICH Compliance 

Clinivex provides drug metabolite reference standards covering an extensive range of small molecule therapeutics — from legacy oral drugs and injectable biologics to emerging targeted therapies and prodrug systems — giving analytical teams access to the authentic reference compounds needed for metabolite structural elucidation, quantitative bioanalytical method development, and human metabolite safety testing (HMST) programs governed by FDA MIST guidance and ICH M3(R2). Each reference standard is produced through validated synthetic routes or isolated from characterized biological matrices, then rigorously confirmed for structural authenticity, chemical purity, and stereochemical integrity using orthogonal analytical techniques including ¹H and ¹³C NMR, LC-HRMS, IR spectroscopy, and chiral HPLC where applicable. For structured metabolite profiling workflows requiring both the parent drug and its major circulating metabolites, our complementary pharmaceutical metabolite standards portfolio provides expanded coverage across CYP450-mediated and phase II metabolite forms.

Clinivex ensures every drug metabolite reference standard is delivered with a fully traceable Certificate of Analysis (CoA) encompassing structural confirmation data, assigned purity values, solvent and concentration details, and recommended storage conditions consistent with GLP principles and ICH Q2(R1) validation expectations. Manufactured through ISO-accredited and GMP-experienced synthesis networks operating across the USA and internationally, our metabolite reference materials offer the batch reproducibility and documentary transparency that regulatory dossiers, audit trails, and multi-site bioanalytical studies depend upon. For isotopically labelled counterparts that serve as internal standards in LC-MS/MS quantification assays, our deuterated reference standards catalog provides high-purity d-labelled analogues. Contact our scientific support team to discuss catalog availability, custom synthesis options, or concentration specifications tailored to your drug development program.