SZEB | Continuous Updates on Nitrosamine Impurities​

Nitrosamine impurities (Nitrosamines), classified as carcinogens by the World Health Organization due to their strong carcinogenicity, have triggered global recalls of multiple drug batches since the detection of N-nitrosodimethylamine (NDMA) in medications such as valsartan and ranitidine in 2018. These recalls involved high-demand drugs for hypertension, diabetes, and other conditions.

In 2025, regulatory scrutiny has intensified again. On July 29, the FDA extended the temporary acceptable intake (AI) limits for eight nitrosamine drug substance-related impurities (NDSRIs) until August 2026. Additionally, the source of N-nitroso-protriptyline was revised to protriptyline tablets.

The eight NDSRIs include:​​

1．N-Nitroso-protriptyline

2．N-Nitroso-ciprofloxacin

3．N-Nitroso-doxylamine

4．N-Nitroso-sertraline

5．N-Nitroso-nortriptyline

6．N-Nitroso-desmethylamitriptyline

7．N-Nitroso-fluoxetine

8．1-Methyl-4-nitrosopiperazine

Simultaneously, EMA added 14 new NDSRIs:​​

1.N-Nitroso-mirdametinib

2.N-Nitroso-berotralstat

3.N-Nitroso-doravirine dimer

4.N-Nitroso-hydroxyzine impurity A

5.N-Nitroso-hydroxychloroquine EP impurity C

6.N-Nitroso-hydroxychloroquine EP impurity D

7.N-Nitroso-methylaminoantipyrine

8.N-Nitroso-methylethanolamine

9.N-Nitroso-desmethyldoxylamine

10.N-Nitroso-nicergoline

11.N-Nitroso nirogacestat  impurity 1

12.N-Nitroso-propafenone impurity B

13.N-Nitroso-venlafaxine EP impurity D

14.N-Nitroso-venlafaxine EP impurity H

Facing dynamic regulatory updates and the structural diversity of NDSRIs, ​​Shenzhen Superior Excellence Biotechnology (SZEB) responds rapidly by supplying relevant drug impurity reference standards. These include full structural confirmation reports with NMR and HRMS.

        Visit the "Nitrosamine Impurities" section on the official website: www.ex-biotech.com  to access the latest NDSRI in-stock catalog: