Updates on impurities in ranitidine products
HSA would like to update the public on our actions and investigations into the contamination of ranitidine products with a nitrosamine impurity, N-Nitrosodimethylamine (NDMA). Ranitidine is a medicine used to reduce the production of acid in the stomach in patients with conditions such as heartburn and gastric ulcers. Please refer below for the latest updates.
Testing methods for NDMA in ranitidine products
This section features test methods developed by the Health Sciences Authority for the identification and determination of a nitrosamine impurity, N-nitrosodimethylamine (NDMA) in ranitidine products.
The testing methods below provide options and guidance for the industry to detect NDMA in ranitidine products. These methods should be validated by users to ensure they are fit for their intended use.