Replies to post #244951 on Biotech Values

[Biowatch]

Possible Nitrosamines in Your Medication

https://www.fda.gov/consumers/consumer-updates/what-know-and-do-about-possible-nitrosamines-your-medication

Where is the nitrosamine coming from? It’s an oddly specific contaminant.

It is/was commonly found in food.
Wikipedia:

Structure of the nitrosamino group
In organic chemistry, nitrosamines (or more formally N-Nitrosamines) are organic compounds with the chemical structure R2N-N=O, where R is usually an alkyl group.[1] They feature a nitroso group (NO+) bonded to a deprotonated amine. Most nitrosamines are carcinogenic in nonhuman animals.[2]

A 2006 systematic review supports a "positive association between nitrite and nitrosamine intake and gastric cancer, between meat and processed meat intake and gastric cancer and oesophageal cancer, and between preserved fish, vegetable and smoked food intake and gastric cancer, but is not conclusive".

Read this:
https://www.outsourcing-pharma.com/Article/2019/10/02/The-five-sources-of-nitrosamine-contamination

And this:
https://ifappacademy.org/news/nitrosamine-contamination-at-a-glance/

Earlier this year, Pfizer found low levels of nitrosamines in the heart medication Accuretic, and a company spokesperson told PharmaVoice that in this case, there was no immediate danger to patients. Still, the level exceeded the threshold set by the FDA, and Pfizer was forced to voluntarily recall batches of the drug.

Experts say that several sources of the impurity are known, and in many cases, the initial discovery stems from the manufacturers. The challenge now is in pinpointing the specific cause each time and creating a system by which pharmaceutical companies can consistently meet purity requirements.

For pharma companies, the narrative of impurities — especially the cancer-causing kind — is one they’d rather avoid. And so, the industry is joining regulators in looking for an answer to the problem, even if the map is pointing in several directions at once.

A multi-pronged issue

Nitrosamines come about from a relatively simple chemical reaction that could happen at different points during the manufacturing of a drug, Koerner says.