BA Sciences provides comprehensive testing for nitrosamine impurities in pharmaceutical products. With our expertise and capabilities on their side, our clients can make sure their products do not exceed the daily intake limits set by health organizations for these potential carcinogens. Accuracy in nitrosamine impurities testing is crucial in order to remain in compliance, and numerous manufacturers depend on our proven processes.
Nitrosamines Testing
Why Testing is Critical
Nitrosamines belong to a well-known group of carcinogens known as N-nitroso compounds. Nitrosamines are known to be toxic to biological cells because of their reactivity with DNA. Nitrosamine formation lies in the oxidative release of the known nitrosating agents, e.g., nitrite and subsequent nitrosamine formation by reaction with secondary and tertiary amines or dealkylated ammonium salts under acidic conditions. These conditions can be found in small molecule drug manufacturing processes, presenting a risk of nitrosamine formation.
In addition, nitrosamines can form from the drug API itself, if the API molecule contains a secondary or tertiary amine group. These nitrosamines are called Nitrosamine Drug Substance Related Impurities (NDSRIs). The FDA has issued guidance for these types of nitrosamines, including specific toxicological limits for known NDSRI compounds. The guidance on the FDA website includes tables of Acceptable Intake (AI) limits for known NDSRI compounds.
Recent investigations have led to the withdrawal or recall of drug products due to the detection of nitrosamine contaminants above the threshold limit, including those containing APIs valsartan, irbesartan, losartan, metformin, ranitidine, and nizatidine.
Trust BA Sciences
Choosing BA Sciences as your nitrosamine testing lab is important for every stage of production. This is because of our knowledge of current FDA regulatory guidance and our advanced methods for detection of nitrosamines in the drug substances, finished products and excipients.
At BA Sciences, we have the knowledge necessary to perform nitrosamine tests quickly, so you won’t have to worry about handling them in-house. Our procedures and equipment are state-of-the-art and meet all regulatory and compliance requirements. Pharma and biotech companies around the world trust our experience to help them create the purest products for their customers.