N-Nitrosodimethylamine (NDMA) Formation from Ranitidine Impurities: Possible Root Causes of the Presence of NDMA in Ranitidine Hydrochloride

• Published in: Chemical & pharmaceutical bulletin Vol. 69; no. 9; pp. 872 - 876
• Main Authors: Yokoo, Hidetomo, Yamamoto, Eiichi, Masada, Sayaka, Uchiyama, Nahoko, Tsuji, Genichiro, Hakamatsuka, Takashi, Demizu, Yosuke, Izutsu, Ken-ichi, Goda, Yukihiro
• Format: Journal Article
• Language: English
• Published: Tokyo The Pharmaceutical Society of Japan 01.09.2021; Pharmaceutical Society of Japan; Japan Science and Technology Agency
• Subjects: Carcinogens; Control stability; Crystal structure; Crystallinity; degradation; Diamines; Impurities; impurity; N-Nitrosodimethylamine; N-nitrosodimethylamine (NDMA); Pharmaceuticals; Ranitidine; Ranitidine hydrochloride; stability; Thermal degradation

N-Nitrosodimethylamine (NDMA) is a probable human carcinogen. This study investigated the root cause of the presence of NDMA in ranitidine hydrochloride. Forced thermal degradation studies of ranitidine hydrochloride and its inherent impurities (Imps. A, B, C, D, E, F, G, H, I, J, and K) listed in t...