Why is Nitrosamine Analysis Important in Pharmaceuticals?

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.

The cost of nitrosamine contamination

The costs of failing to detect nitrosamines in pharmaceutical products are enormous. In high profile cases, recalls and lawsuits triggered by high nitrosamine concentrations can cost big pharma companies millions. A recent report issued by Morgan Stanley predicts manufacturers of a popular stomach acid medication called Zantac could spend more than US$45 billion on recalls. Pharmaceutical giant Pfizer was also recently forced to recall some batches of a blood pressure drug called Accuretic after nitrosamine levels above the Acceptable Daily Intake (ADI) were detected.

“These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time,” reads a statement issued by the company.

The cancer-causing effects of nitrosamines

In an article published in the International Journal of Environmental Research and Public Health, the authors investigate the cancer risks associated with common medications contaminated with nitrosamines. In California, more than 30 nitrosamine types are listed on Proposition 65, a law that requires businesses to warn consumers about exposure to cancer-causing chemicals. The findings were alarming, with the authors warning that nitrosamine contamination in long-term drugs can significantly increase cancer risks and should be considered a serious threat to public health. Not just in California but across the globe.

“Our risk analyses underscore the importance of preventing nitrosamine contamination from occurring in widely used drugs, and the necessity of removing contaminated drug products from the market,” reads the conclusion. “Prompt manufacturing changes and continued monitoring by US FDA are needed to address this serious public health issue. Ultimately, the presence of carcinogenic contaminants in drugs may affect treatment preferences, patient compliance, and health outcomes.”

Nitrosamines vs VOCs

Nitrosamines aren’t the only cancer-causing compounds making headlines. Volatile Organic Compounds (VOCs) found in everyday products like furniture and paint are also a major health concern. Find out more about the latest techniques being used to detect and quantify the harmful group of chemicals in ‘Measurement of VOCs in Vehicle Interiors Using Thermal Desorption GC-MS with Nitrogen as the Carrier Gas’.