The Stable Isotope Labelled New Drug Substance Reference Standards (SIL-NDSRI) are customised reference materials that combine the benefits of isotope labelling with the rigorous characterisation of NDSRIs. These standards are designed for use in advanced bioanalytical techniques and ensure the highest level of accuracy in pharmaceutical testing.

FAQ

Pricing for Daicel’s stable isotope-labelled nitrosamine standards reflects molecular complexity, isotopic labelling strategy, synthetic route, required purity and characterization depth. As many NDSRIs are non-catalogue and project-specific, Daicel follows a consultative model to align scientific rigor with project needs. This approach ensures cost transparency while delivering materials suitable for regulated analytical and submission-critical applications.

Selecting the right labelled nitrosamine standard requires consideration of isotopic placement, chemical stability, purity and analytical equivalence to the target impurity. Daicel Pharma Standards emphasizes intentional design and full characterization to ensure reliable co-elution and mass differentiation. Regulatory documentation, traceability and suitability for low-level quantification are equally critical for method validation and compliance-driven studies.

While stable isotope-labelled NDSRIs can be manufactured in India, Daicel Pharma Standards differentiates itself through globally harmonized quality systems and advanced impurity science. Daicel’s materials are designed to meet international regulatory expectations, making them suitable for multinational development programs. This ensures that customers receive scientifically justified, regulator-ready standards regardless of manufacturing geography.

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