Nitrosamine testing in human medicines containing chemically synthesized active substances.
Nitrosamines are classified as probable human carcinogens (substances that could cause cancer) on the basis of animal studies. They are present in some foods and in water supplies but are not expected to cause harm when ingested in very low levels.
In 2018, nitrosamines were found in a number of blood pressure medicines, known as “sartans”, leading to a recall of several products and an EU review, which set strict new manufacturing requirements for these medicines. Since then, a nitrosamine impurity has been detected in a few batches of pioglitazone from one company and in batches of ranitidine.
An EU wide review has been initiated.
Qualimetrix employs the analytical method proposed by the EDQM for the determination of NDMA and NDEA that has been used for various types of APIs and final products.
The method is based on the principle of UHPLC-APCI-MS/MS.