Isotope Labelled Standards

Isotope-labelled standards from Daicel closely mimic the physicochemical behavior of the target analyte, while remaining distinguishable by mass spectrometry. This enables accurate quantification, compensates for matrix effects and improves method robustness. Their use enhances precision in bioanalytical assays, impurity profiling and pharmacokinetic studies, supporting confident data generation across development stages and meeting regulatory expectations for method validation.

Yes. Daicel Pharma Standards develops isotope-labelled compounds under quality systems aligned with global regulatory requirements. Materials are supported by detailed certificates of analysis, traceable analytical data and scientifically justified specifications. This regulatory-focused approach ensures suitability for use in regulated bioanalytical studies, stability programs and submissions to major health authorities, reducing compliance risk for global pharmaceutical and biotechnology customers.

Daicel offers custom synthesis of isotope-labelled compounds, including complex small molecules, metabolites, peptides and impurities. Leveraging deep expertise in synthetic chemistry and impurity design, Daicel can introduce labels such as deuterium or carbon-13 at strategically relevant positions. This capability enables tailored solutions when catalogue products are insufficient, supporting challenging analytical, metabolic and regulatory applications.

Daicel’s isotope-labelled standards are designed for high chemical and isotopic stability when stored under recommended conditions, typically at low temperature and protected from light and moisture. Stability considerations are evaluated during development and guidance is provided with each product. Proper storage preserves isotopic integrity and analytical performance, ensuring long-term reliability for routine testing and regulated studies.