Valisure announced the addition of elemental analysis for toxic elements to its standard testing methods, which currently includes dosage, major inactive ingredients, dissolution, and analysis for the presence of carcinogens such as N-Nitrosodimethylamine (NDMA).
Valisure’s elemental analysis includes testing for 24 of the most common elemental contaminants including lithium, arsenic, mercury, lead, and nickel, among others. To identify the presence of these toxic elements, Valisure utilizes inductively coupled plasma mass spectrometry (ICP-MS) technology. ICP-MS is highly selective and sensitive, offering a broader range of detection compared to other techniques for elemental analysis and also allows for the detection of several types of elements at a time.
“Valisure began implementation of analysis for elemental impurities following the release of recent industry guidance for pharmaceuticals. The early adoption of elemental testing reflects our proactive commitment to quality assurance in the medications that we provide,” said Dr. Kaury Kucera, Chief Scientific Officer of Valisure. “It is through these advanced testing methods that we continue to bring additional transparency and peace of mind to our patients and their families.”
In recent years, there has been growing awareness of the presence and potential dangers of heavy metals in everyday products. Heavy metal toxicity can have numerous adverse health effects on the human body and can potentially affect the functioning of organs such as the kidney, lungs, and liver. Heavy metal toxicity can have both acute or chronic effects and long-term exposure to heavy metals can progressively lead to muscular, physical, and neurological degeneration.
“Valisure is a leader in independent drug product testing, a growing and critical component of improving the safety and quality of our pharmaceutical supply. It was though the continual growth of our testing capabilities that we identified a fourth major carcinogen in valsartan, discovered the fundamental instability of ranitidine, and detected high levels of NDMA in many batches of metformin,” explained David Light, founder and CEO of Valisure. “The subsequent global recalls of both ranitidine and metformin underscore the immense impact that our testing has had and is proof of the need for independent chemical testing of all medications.”
Powered by Embed YouTube Video