Nitrosamine: The Carcinogenic Impurity in Angiotensin Receptor Blockers

Sandip P. Zine; Sayli A. Sawant; Nilesh Mhapankar

Abstract

Angiotensin II Receptor Blockers (ARBs), commonly known as the Sartans, are used in the treatment of hypertension for a long time. Currently, seven Sartan drugs, i.e. Valsartan, Losartan, Candesartan, Irbesartan, Telmisartan, Olmesartan, and Eprosartan, are in use. Recently, Nitroso impurity was detected in Valsartan active pharmaceutical ingredient, which led to the recall of batches of products containing it. Even in trace amounts, the impurity is said to be a probable human carcinogen. The impurity is thought to be formed by a change in the manufacturing process of Valsartan, which includes the use of Sodium azide. Also, impurities were detected in Losartan and Irbesartan as well. Regulatory bodies, such as the US FDA, have put forward some testing methods for detecting impurities. The impurities seen during the manufacturing process must be tested thoroughly and also care should be taken while making changes to the manufacturing process. This review focuses on the cause of impurity generation and also ways to avoid it Keywords: Sartan drugs, Nitroso impurity, Human Carcinogen, US FDA, Sodium azide Cite this ArticleSandip P. Zine, Miss. Sayli A. Sawant, Mr. Nilesh Mhapankar. Nitrosamine: The Carcinogenic Impurity in Angiotensin Receptor Blockers. Research & Reviews: Journal of Oncology and Hematology. 2020; 9(3): 36–43p.