The general structure of these small molecules
Nitrosamines
What Are Nitrosamines?
Nitrosamines are small nitrogen, carbon and oxygen containing compounds which are probable human carcinogens (cancer causing). They are present in some food and pharmaceutical products.
Structure
N=nitrogen
O=oxygen
R1 and R2 = short chains of mainly carbon and hydrogen.
How do they form?
Nitrosamines can form when compounds called amines are present in the presence of oxidizing agents such as nitrites, peroxides (like bleach). These contaminants can form nitrosamines during production/growth or can grow slowly over the shelf-life of a product.
What do they do?
Chronic exposure (consistent exposure over time) to nitrosamines can lead to cancer. Nitrosamines can damage DNA or can be metabolized further into other potentially cancer-causing agents.
Where are they found?
Nitrosamines (or their precursors) are found in air, food, water, cosmetics, tobacco, packing materials and drugs.
Nitrites in the soil (from fertilizers, pesticides) can be incorporated into growing plants and converted to nitrosamines resulting in their presence in food crops
In pharmaceuticals, amines can be utilized as building blocks to synthesize drugs or can be present in solvents or reagents used to run the chemical processes. There can be contamination of oxidizing agents from reagents and solvents used to make drugs.
Precursors can be present and the act of cooking or burning can create the actual nitrosamine compound. An example is bacon—where nitrites are present—upon cooking the bacon, nitrosamines can form. Another is smoking tobacco.
Detection Levels
In pharmaceuticals, we have specific testing, both when we release a drug to the market and for stability testing of that drug.
Because nitrosamines are considered carcinogenic, the levels allowed in pharmaceuticals is very low. The FDA has specified "acceptable intake" limits for a group of known nitrosamines that range from 26 to 100 ng/day.
The extremely low level makes detection and quantitation a challenge for our analytical teams.
1gram = 1000 milligrams (mg)
1mg = 1000 micrograms (µg)
1µg = 1000 nanograms (ng)
Relative Amounts
Nanograms per day — what does that look like?
One nanogram is a billionth of a gram (a non-glossy business card weighs about one gram).
Let’s translate that to real life:
An Olympic sized swimming pool is about 660,000 gallons or 2,500,000 liters of water. One billionth of that amount is about ½ of a teaspoon or 2.5 milliliters!
Our test methods need to be able to detect down to 13 teaspoons or 65mL of water out of an Olympic pool!
