Daicel Pharma Standards supports the entire product development cycle with expertise in the synthesis and supply of impurity standards and stable isotope labelled standards. Our capabilities span complex small molecules, peptides, and oligonucleotides, backed by advanced analytical and purification technologies. Quantification of impurities in pharmaceutical drugs is carried out using Certified Impurity Standards of known purity and potency.
Daicel Pharma Standards provides impurity standards of superior quality to support precise and reliable impurity quantification, fully aligned with regulatory expectations. With a comprehensive ready-to-ship inventory, we provide speed, consistency, and confidence across every analysis. Through scientific precision and close collaboration, we offer high-quality, time-bound solutions that empower innovation.
Driven by a strong commitment to sustainability and quality excellence, we don’t just deliver standards — we set them.
Drug Impurity Standards
High-purity certified reference materials used to identify and quantify, impurities in drug substances and drug products. These standards play a critical role in analytical method validation and quality control of drugs by ensuring regulatory compliance.
Labeled Standards
Stable isotope-labeled compounds (¹³C, ²H, ¹⁵N) used as internal standards for LC-MS applications. They enhance quantitative accuracy, precision, and reproducibility by compensating matrix effects during method validation and routine analysis.
NDSRIs Standards
Specialized reference standards for the detection and quantification of nitrosamine impurities of drug substances and intermediates in pharmaceuticals. Essential for validating sensitive analytical methods that safeguard product quality and patient safety.
SIL NDSRIs
Stable isotope-labeled standards of NDSRIs designed for highly accurate quantification in LC–MS analyses. These standards serve as internal standards during NDSRI method validation, improving detection sensitivity, matrix correction, and regulatory compliance in nitrosamine testing.
E & L Standards
Comprehensive standards to assess chemical substances migrating from packaging or process materials into drug formulations. They support method validation for E&L studies, ensuring accurate identification and quantification of potential contaminants.
Peptide Impurity Standards
Well-characterized reference peptides representing process related and degradation impurities. These standards enable reliable method validation and impurity profiling in the development and quality control of peptide therapeutics.
Oligonucleotide Impurity Standards
Authentic reference oligonucleotides reflecting process related and degradation impurities. They facilitate reliable method validation and impurity profiling in the development and quality control of oligonucleotide-based drugs.