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Stable Isotope Labelled Standards

Stable isotope labelled standards are chemically identical analogues of a target compound, synthesized with stable isotopes such as deuterium, carbon-13, nitrogen-15, or oxygen-18, and used as internal standards to correct for matrix effects and improve the accuracy of quantitative mass spectrometry. Clinivex supplies precisely synthesized stable isotope labelled standards engineered for the most demanding quantitative analytical workflows in pharmaceutical research, clinical bioanalysis, environmental testing, and metabolomics. Our catalog features deuterium (D), carbon-13 (13C), nitrogen-15 (15N), and oxygen-18 (18O) labelled compounds – each serving as a chemically identical internal standard that improves the accuracy and reproducibility of LC-MS/MS, GC-MS, and HRMS-based quantification. As a specialized isotope labelled reference standards provider, we support bioanalytical laboratories, CROs, pharmaceutical QC teams, and academic research institutions across regulated markets in 120+ countries. Looking for a specific labelled compound? Request a quote below.

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Stable Isotope Labelled Standards for Bioanalytical Quantification and Mass Spectrometry

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 for use as internal standards in quantitative mass spectrometry workflows. Each compound co-elutes with its unlabelled analyte, correcting for matrix effects, ionization variability, and sample preparation inconsistencies in complex biological matrices such as plasma, urine, tissue homogenates, and cerebrospinal fluid.

Why Use an Isotope Labelled Internal Standard

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.

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How to Choose an Isotope Labelled Reference Standard
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Quality, Documentation, and Regulatory Alignment

Each stable isotope labelled standard arrives with the documentation your regulatory submissions and GLP study reports depend on.

  • Detailed Certificate of Analysis (CoA) with every standard.
  • Isotopic purity, chemical purity, and molecular weight verification.
  • Solubility data included for method development and dilution planning.
  • Aligned with FDA BMV guidance, EMA BMV guidelines, and ICH M10.
  • Manufactured under ISO-compliant quality systems by vetted synthesis partners.

why Choose Clinivex?

At Clinivex, we earn trust by delivering impeccable service, expert guidance, and reliable solutions that drive long-term success. With a skilled team and customer-first approach, we stand as a leading pharmaceutical reference standards supplier in the USA and Canada.

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    Frequently Asked Questions

    They’re used as internal standards in quantitative mass spectrometry workflows, correcting for matrix effects, ionization variability, and sample preparation inconsistencies in complex biological matrices.

    Yes. Every stable isotope labelled standard from Clinivex ships with a Certificate of Analysis confirming isotopic purity, chemical purity, molecular weight verification, and solubility data.

    Our standards are aligned with FDA Bioanalytical Method Validation guidance, EMA BMV guidelines, and ICH M10 requirements.

    Yes, Clinivex supplies laboratories in 120+ countries.

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