Metabolites

Authentic Pharmaceutical Metabolite Standards for ADME Profiling, Safety Testing, and Regulatory Submissions

Clinivex stocks an expansive range of pharmaceutical metabolite standards spanning major therapeutic categories, including cardiovascular agents, CNS compounds, anti-infectives, oncology drugs, and immunomodulators, covering hydroxylated, glucuronidated, sulfated, N-oxide, and N-dealkylated metabolite forms that routinely emerge from CYP450-mediated and non-CYP biotransformation pathways. These authenticated reference compounds are indispensable for metabolite identification and structural confirmation by LC-HRMS and NMR, absolute quantification in plasma and urine matrices using validated LC-MS/MS bioanalytical methods, and disproportionate metabolite assessment required under the FDA MIST guidance and ICH M3(R2) framework. Each standard undergoes comprehensive characterization encompassing chemical purity determination, structural identity verification, and chiral purity assessment – ensuring your metabolite data package meets the evidentiary standard expected by FDA, EMA, and PMDA reviewers. For related drug substance metabolite workflows in preclinical safety evaluation, our drug metabolite reference standards catalog extends coverage to glucuronides, sulfates, N-oxides, and conjugative metabolites across a broad spectrum of therapeutic classes.

Every pharmaceutical metabolite standard from Clinivex is released with a detailed Certificate of Analysis (CoA) that documents purity, structural confirmation, solvent system, concentration, and storage stability, aligned with GLP documentation principles and ICH Q2(R1) analytical validation requirements. Sourced from ISO-compliant and GMP-experienced synthetic partners with proven track records in complex metabolite synthesis, our reference materials offer the batch consistency and regulatory traceability your bioanalytical validation studies and safety qualification reports require. For internal standard solutions to pair with your metabolite quantification assays, our stable isotope labelled standards provide isotopically enriched counterparts that enhance assay accuracy in complex biological matrices. Engage our technical team early in your program to ensure the right metabolite standards are secured for your specific drug candidate and study design.