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.

Types of communication Date of release Title
HSA Update 1 16 Sep 2019 HSA stops supply of eight brands of ranitidine products in Singapore

 

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.

Date of release Title
12 Sep 2019 Test method for determination of N-nitrosodimethylamine (NDMA) in ranitidine products by LC-MS/MS 154 KB
18 Sep 2019 Test method for identification of six nitrosamine impurities in western medicines by LC-HRMS 514 KB
Consumer, Healthcare professional, Industry member, Therapeutic Products

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