NDSRI Products

Pricing and availability of Daicel’s nitrosamine drug impurity standards are typically assessed through direct consultation, reflecting the customized and non-catalogue nature of many NDSRIs. Customers can engage Daicel’s technical team to discuss compound structure, required quantity, isotopic labelling and timelines. This consultative approach ensures scientifically appropriate solutions while balancing analytical needs, regulatory expectations and project timelines.

Daicel’s nitrosamine standards are developed with a regulatory-first mindset, combining controlled synthesis, rigorous safety practices and multi-technique characterization. These standards are designed to support ultra-trace analytical methods, including LC-MS-based assays and align with evolving global guidance on nitrosamine risk assessment. Their scientific reliability and documentation quality make them well suited for regulatory submissions and compliance-driven testing programs.

While several suppliers in India offer reference standards, Daicel Pharma Standards differentiates itself through global quality systems, advanced impurity design capability and international regulatory alignment. Daicel’s NDSRIs are developed to meet the expectations of multinational pharmaceutical companies and health authorities, making them suitable for global development programs where consistency, traceability and scientific justification are critical to analytical and regulatory success.

Yes. Daicel Pharma Standards supplies NDSRIs, including nitrosamine impurity standards, to customers in the United States supporting regulated analytical and development activities. These materials are used across method development, validation, stability testing and regulatory submissions. Daicel’s experience with global customers ensures that standards meet the scientific rigor and documentation expectations required by US regulatory and quality frameworks.