What exactly are Nitrosamines?

Pharmaceutical products are designed to improve human health. However, impurities like high concentrations of nitrosamines can cancel out the benefits. This is why nitrosamine analysis has a critical role to play when it comes to screening pharmaceutical products and protecting the interests of consumers.

What exactly are Nitrosamines?

Nitrosamines are a group of organic compounds formed during chemical reactions. Most pharmaceutical products are highly processed, which increases the risk of nitrosamine formation during manufacturing. So, what makes nitrosamines such a risk? The organic compounds have proven carcinogenic properties and can increase the risk of developing some cancers. This makes them a major concern for pharmaceutical manufacturers. While nitrosamines alone aren’t carcinogenic, human metabolic processes can convert them into DNA-modifying alkylating agents that can result in mutations.

Nitrosamines have had historical applications in pharmaceuticals, primarily as intermediates in organic synthesis. However, due to their carcinogenic properties, their use in pharmaceuticals has become highly regulated and minimized.

In recent years, there have been regulatory concerns regarding the presence of nitrosamines as impurities in pharmaceutical products. For example, in 2019, several batches of medications containing the active ingredient valsartan were recalled due to the detection of nitrosamine impurities, such as N-nitrosodimethylamine (NDMA), beyond acceptable limits. This led to increased scrutiny by regulatory agencies worldwide and prompted pharmaceutical companies to implement more stringent testing and quality control measures to detect and prevent the presence of nitrosamines in their products.

Simson is specialized in delivering nitroso amine impurities with Certificate of analysis along with characterization and purity. We are equipped with ultra-high performance LC-MS and Triple quadrupole MS Mass Spectrometers for accurate determination of purity. Simson also provide characterization DATA report such as 1HNMR, 13C NMR, MASS, IR, TGA & HPLC.

Simson recently synthesized NITROSOAMINES list are as follows:- Check all Products