Stable isotope labelled compounds

Stable Isotope Labelled Standards for Bioanalytical Quantification and Mass Spectrometry Applications

Clinivex offers an extensive selection of stable isotope labelled standards covering small molecule drugs, endogenous metabolites, lipids, amino acids, bile acids, steroids, and environmental contaminants, all produced with high isotopic purity and chemical integrity to function as reliable internal standards in quantitative mass spectrometry workflows. These compounds correct for matrix effects, ionization variability, and sample preparation inconsistencies that commonly compromise assay accuracy in complex biological matrices such as plasma, urine, tissue homogenates, and cerebrospinal fluid. For workflows requiring purely deuterium-labelled analogues, our dedicated deuterated reference standards portfolio provides targeted d-labelled compounds across therapeutic drug classes and environmental contaminants. Whether you are developing a PK/PD bioanalytical method, validating a clinical diagnostic assay, conducting exposome research, or performing therapeutic drug monitoring, our isotope labelled reference standards deliver the measurement confidence your data integrity program demands.

Clinivex guarantees that every stable isotope labelled standard is supplied with a detailed Certificate of Analysis (CoA) confirming isotopic purity, chemical purity, molecular weight verification, and solubility data, fully aligned with FDA Bioanalytical Method Validation guidance, EMA BMV guidelines, and ICH M10 requirements. Manufactured under ISO-compliant quality systems by globally recognized synthetic chemistry partners, our isotope standards give your regulatory submissions and GLP study reports an unassailable analytical foundation. Connect with our technical team to identify the right labelled internal standard for your specific compound and matrix. For metabolomics and pharmacokinetic profiling applications, our pharmaceutical metabolite standards catalog offers complementary authentic metabolite references for quantitative bioanalysis.