Nitrosamine-contaminated medicinal products and cosmetics have raised safety concerns because of their high potential to cause cancer. Regulatory authorities worldwide have established stringent guidelines to limit exposure to nitrosamines. Tepanox actively supports various stakeholders by providing services to preempt the risk and tackle the crisis. In addition to selling analytical standards, we also sell nitrosating reagents and intermediates that mitigate the formation of nitro amines. Nitrosomaines are organic compounds featuring a nitroso group and amino group.

Nitrosamines can originate from:

1. ‍‍Starting materials and their impurities,
2. Catalyst, reagent, solvents, by-products, and intermediates,
3. Degradation products on storage and shipment.

The formation of nitrosamines is triggered when secondary or tertiary amines react with nitrous acid. These are also commonly present in cosmetics, and one of the difficulties is that they often form over time from the reaction of nitrite preservatives with amines. Multiple nitrosamines, DMA, NDEA, NEIPA, NDIPA, NMBA, MeNP, NDBA, and NMPA, and the corresponding exposure thresholds have been established. Various LC-MS/MS-quadrupole mass spectrometry and high-resolution accurate mass (HRAM) methods have been developed to analyze and quantify nitroamines.

Even at a very low level, unqualified impurities in pharmaceutical products may pose unknown health risks to patients. Profiling the impurities is essential for maintaining drug safety and efficacy and meeting various regulatory requirements. At Tepanox, we specialize in sourcing new and known compounds, from contaminants to customized chemical compounds and rare organics. We understand the industry research needs thoroughly and have earned a reputation for being reliable partners to support drug development and medical and biomedical research professionals. Our services help avoid product recalls significantly affecting consumers and pharmaceutical companies.