Nitrite impurities are found in a range of commonly used excipients, which may lead to nitrosamine impurities forming in drug products during the drug product manufacturing process and shelf-life storage. Therefore, it is important to limit the nitrite and amine levels in drug s...
common nitrosating agents, are often found in excipients such as preservatives, stabilizers, and fillers. These impurities can react with the amines present in the API, leading to nitrosamine formation during the
The Sixth edition of Nitrosamine Impurities forum scheduled on 11th-12th of December, 2024, in Mumbai will have two days interactive Workshop. The forum aims at bringing industry participants up to date on the constantly evolving nitrosamines saga with a focus on regulatory requirements and their ...
guidance for the assessment and control of NAs in drug products (EMA, 2020; FDA, 2021), it became apparent that there was an additional need to establish an agreed framework to support the rapid derivation of Acceptable Intakes (AIs) for N-nitrosamine Drug Substance Related Impurities (NDSRIs...
(European Medicines Heads of medicines agency, 2020;Heads of medicines agency, 2020). Numerous recalls followed this announcement throughout the world. A year after this announcement, many investigations were carried out, which detected traces of these impurities in Ranitidine, a H2blocker used to ...
Nitrosamine Impurity: Management of Unwelcome Guest in Pharma Market Nitrosamine impurities have been detected in various pharmaceutical products in recent days. Various sartans, ranitidine, nizatidine and metformin have bee... AI Patel,AK Mandavia,AJ Vyas - 《Asian Journal of Pharmaceutical Analysis》...
Nitrosamine - testing for its impurities: Nitrosamine impurities such as N-nitrosodimethylamine (NDMA) continue to be an area for concern as highlighted by the US FDA and other regulatory authorities. At Intertek we believe flexible solutions are the way forward to overcome technical challenges and ...
With recent stories about generic drug product containing unacceptable levels of nitrosamine impurities, consumers and pharmaceutical manufacturers alike, have reasons to be concerned.
Once in a while, you may see news regarding medications being recalled or pulled back from the market because they contain certain impurities/contaminants, which may pose health risks to the patients. The product recall of losartan, a blood pressure medication, took place in the year 2019 beca...
Nitrites are common nitrosating impurities that have been reported in many excipients at part per million levels. Guidelines from FDA and EMA have identified potential nitrosamine impurities that could theoretically be present in drug products. As part of the guidelines, it's crucial to have an ...