Helping to Ensure Reliability and Stability of Drug Reference Materials
Setting the Standard for Quality
Regulatory requirements for drug safety, efficacy, and quality make impurity profiling an essential part of drug development and manufacturing. This process is highly complex due to the structural diversity and heterogeneity of small molecule active pharmaceutical ingredients (APIs). Challenges such as impurity degradation, poor separation during API-impurity co-elution, and the low solubility of hydrophobic impurities require the use of advanced analytical methods.
Trust USP to provide high-quality reference materials to help you identify, characterize, and control impurities in your drug products.
Leverage Our Expertise in Nitrosamines, Synthetic Chemistry, and Analytical Development
- USP’s expanded portfolio of nitrosamine reference materials includes over 60 well-characterized Pharmaceutical Analytical Impurities (PAIs) for simple nitrosamines, NITMAs, and NDSRIs associated with drug substances like Sitagliptin, Duloxetine, and Rasagiline.
- We offer eight (8) USP Reference Standards to support the analytical methods outlined in General Chapter <1469> Nitrosamine Impurities.
Our commitment to quality helps to ensure that manufacturers can confidently identify and control nitrosamine impurities-safeguarding patient health while meeting stringent regulatory requirements.
USP Nitrosamines Exchange: A knowledge-based, online community for all-things nitrosamine.
Join USP's Nitrosamines Exchange for real-time conversations and insights from industry leaders. Learn about the latest strategies for reducing the risks related to nitrosamines.
Sign up to be notified when future USP Nitrosamine Reference Materials are released.
Help shape the future of Pharmaceutical Analytical Impurities.
USP’s catalog of Pharmaceutical Analytical Impurities is growing rapidly. However, please tell us if you do not find a Nitrosamine required for your analytical work, by connecting with your USP Account Manager or emailing us at PAI@usp.org.
*Pharmaceutical Analytical Impurities are released using a process developed by USP’s subject matter experts. The release process is based on internal policies, standard operating procedures, and requirements as defined by USP’s Quality Management System. USP is an ISO 9001:2015 certified facility. PAI products are different from official USP Reference Standards. PAI products are not required for compendial compliance.