How do you test for nitrosamines?
The current most common methods for testing small-molecule pharmaceutical products are gas chromatography–mass spectrometry (GC–MS), liquid chromatography (LC)–MS/MS or high resolution (HR) LC–HRMS.
What cancer is associated with nitrosamines?
Nitrosamines are considered to be strong carcinogens that may produce cancer in diverse organs and tissues including lung, brain, liver, kidney, bladder, stomach, esophagus, and nasal sinus.
What foods contain nitrosamines?
Foods which have been shown to contain volatile nitrosamines include cured meats, primarily cooked bacon; beer; some cheeses; nonfat dry milk; and sometimes fish. It should be emphasized that not all samples analyzed contain detectable amounts of nitrosamines.
What does N nitrosamines do to your body?
Nitrosamines form a large group of genotoxic chemical carcinogens which occur in the human diet and other environmental media, and can be formed endogenously in the human body. N-Nitroso compounds can induce cancer in experimental animals.
Why are nitrosamines carcinogenic?
Nitrosamines are not directly carcinogenic. Metabolic activation is required to convert them to the alkylating agents that modify bases in DNA, inducing mutations.
How do you detect NDMA?
The FDA has released the following methods for the determination of NDMA impurities in drugs.
- GC/MS Headspace Chromatography Mass Spectrometry Approach.
- Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) Method for the Determination of NDMA in Ranitidine Drug Substance and Solid Dosage Drug Product.
How are nitrosamines carcinogenic?
Do cigarettes contain nitrosamines?
Tobacco-specific nitrosamines (TSNAs) are thought to be some of the most potent carcinogens in tobacco products. They are unique to tobacco and present in smokeless tobacco, snuff, cigarettes, and electronic cigarette liquid.
How did NDMA get into valsartan?
Experts suggest that the NDMA impurity in valsartan could have come from sodium nitrite, which is used to mop up remaining sodium azide reagent. The nitrite forms nitrous acid under acidic conditions that then could react with trace amounts of dimethylamine, a degradate of the solvent dimethylformamide.