Our proprietary separation technology enables superior purification of active pharmaceutical ingredients and intermediates, eliminating contaminants and impurities while maintaining yields across commercial scales.
The definitive solution to the pharmaceutical industry's most critical contamination challenge.
Nitrosamines have triggered billions of dollars in recalls and shaken regulatory confidence worldwide. Conventional removal methods are either ineffective or are slow, destructive, and economically unsustainable at production scale.
Our patent pending technology achieves selective removal of nitrosamines to concentrations beneath the newly established FDA acceptable intake (AI) limits, while minimizing valuable API losses—faster and at a fraction of conventional costs.
This platform is effective on small molecule nitrosamines, as well as nitrosamine drug substance-related impurities (NDSRIs), ensuring comprehensive coverage of both problem classes.
Our cutting‑edge purification techniques drive impurities and contaminants far below regulatory thresholds, ensuring every API complies with the most stringent global standards.
A streamlined pathway engineered for speed and precision.
Comprehensive impurity profiling and process analysis
Custom protocol development for your specific API
Precision separation achieving target specifications
Complete documentation for regulatory compliance
Our advanced purification technology serves diverse pharmaceutical manufacturing needs, from complex biologics to difficult isomer separations.
Isolation of peptides, proteins, enzymes, and other biological compounds while preserving structural integrity and bioactivity.
Removal of impurities from excipients to meet stringent pharmaceutical grade specifications and regulatory requirements.
Selective separation of compounds, especially isomers, enabling chirally pure products and enhanced therapeutic efficacy.
Reach out to our team to discuss your purification requirements. Our experts are ready to assess your specific challenges and develop customized solutions.
Corporate Office
R&D Center
info@kiralitypharma.com
Our team typically responds within one business day.