Update on impurities in metformin products

HSA would like to update the public on our actions and investigations into the contamination of metformin products with a nitrosamine impurity, N-nitrosodimethylamine (NDMA). Metformin is an oral diabetes medicine that helps control blood sugar levels. Combined with diet and exercise, metformin improves blood sugar level control in adults with type 2 diabetes mellitus.

 Types of communication Date of release    Title
 HSA Update 1  4 Dec 2019 HSA Recalls Three Out Of 46 Metformin Medicines


Testing methods for NDMA in metformin products

This sections features test methods developed by the Health Sciences Authority for the identification and determination of a nitrosamine impurity, N-nitrosodimethylamine (NDMA) in metformin products.

The testing method below provide options and guidance for the industry to detect NDMA in metformin products. This method should be validated by users to ensure they are fit for their intended use.

Date of release  Title 
1 March 2021 Test method for determination of N-Nitrosodimethylamine (NDMA) in metformin products by HRAM-GCMS177 KB
1 March 2021  Test method for determination of N-Nitrosodimethylamine (NDMA) in metformin and ranitidine products by LC-MS/MS151 KB

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