RIYADH: The Saudi Food and Drug Authority discovered a new innovative technology to detect Nitrosamine impurities in medicine, according to the authority’s published report.
The SDFA report explained nitrosamines were found in ranitidine medication by using the new technological method. This comes as part of the continued work of the authority in examining food and pharmaceutical products.
Nitrosamine impurities became a topic of focus when health regulators recalled valsartan, an antihypertensive drug, due to the presence of N-nitrosodimethylamine, a probable carcinogenic agent and a key member of the nitrosamine class.
Since the valsartan recall, several batches of medicines contaminated with nitrosamines came to be known. The proportion of nitrosamines in these drugs does not pose a significant risk — in fact, small quantities of nitrosamines are found in foods and water — as most people are exposed to them daily in minute quantities. However, the recall of commonly used drugs caused disruptions for patients across the globe.
Nitrosamines can increase the risk of certain types of cancer. The chemical was found in small proportions in Ranitidine, which is a group of drugs used to treat and prevent ulcers in the stomach.
The authority’s new innovative technology relies on micro-extraction in the solid phase to measure the levels of impurities.