Updates on impurities in high blood pressure medicines

HSA would like to update the public on our actions and investigations into the potential contamination of angiotensin II receptor blockers (ARBs) with nitrosamine impurities such as N-Nitrosodimethylamine (NDMA), N-Nitrosodiethylamine (NDEA), N-Nitroso-N-methyl-4-aminobutyric acid (NMBA). The ARB class of medicines is used for the control of high blood pressure. Please refer below for the latest updates.

Types of communication	Date of release	Title
Press Release	28 Mar 2019	HSA Recalls Three Brand of Losartan Medicines from Hetero Labs Ltd
HSA Update 3	07 Mar 2019	HSA Updates on Overseas Recall of Angiotensin II Receptor Blockers (NMBA impurity)
HSA Update 2	19 Dec 2018	HSA Updates on Overseas Recall of Angiotensin II Receptor Blockers (NDMA and NDEA impurities)
HSA Update 1	29 Aug 2018	HSA Updates on Overseas Recall of Valsartan Medicines (NDMA impurity)

 

Testing methods for NDMA, NDEA and NMBA in Angiotensin II Receptors Blockers

This section features test methods developed by the Health Sciences Authority for the identification and determination of nitrosamine impurities in angiotensin II receptor blockers (ARBs).

The testing methods below provide options and guidance for the industry to detect nitrosamine impurities in ARB medicinal products. These methods 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 six nitrosamine impurities in western medicines by LC-MS/MS228 KB

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