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Drug-NDMA-impurities-Ranitidine-analysis

Analysis of N-Nitrosodimethylamine (NDMA) – Impurities in Ranitidine

In September 2019, the U.S. Food and Drug Administration (FDA) published a statement of NDMA found in samples of ranitidine, a drug used to treat peptic ulcer disease, gastroesophageal reflux disease and Zollinger-Ellison syndrome.

NDMA is a substance from the class of compounds known as Nitrosamines and is well documented to be an environmental contaminant found in water and foods, including various meats, dairy products, and vegetables.

 

Samples tested positive for NDMA residues

 

In late September 2019, the FDA alerted health care professionals and patients to a voluntary recall of ranitidine medicines. Nevertheless, it turned out that some methods for the detection of NDMA residues were using elevated temperatures which induced the artificial synthesis of NDMA.

In November 2019, the FDA published a list of laboratory results of NDMA in ranitidine and nizatidine products that clearly showed all samples tested positive for NDMA residues. Although detectable levels of NDMA were found in each sample, the concentration varied significantly between the different products. The FDA has set the acceptable daily intake limit for NDMA at 0.096 micrograms or 0.32 ppm for ranitidine – which is exceeded by several products tested.

Other countries and agencies are reviewing this issue as well – e.g. in September 2019 the European Medicines Agency (“EMA to review ranitidine medicines following detection of NDMA” or in October 2019 the Mexican Federal Commission for the Protection against Sanitary Risks (COFEPRIS) “La Cofepris informa sobre los productos que contienen dentro de su formulación al principio activo Ranitidina”.

 

Testing of possible NDMA impurities at Adamson Analytical Laboratories

 

The Tentamus Lab “Adamson Analytical Laboratories”, based in Corona, CA is proud to offer the testing of possible NDMA impurities in your product. Adamson has developed a method that does not require any heating of the sample, thus eliminating any risk of false positives from heat treatment during the analysis of your product.

As it is vital to obtain the necessary data in short time, Adamson Analytical Laboratories guarantee a maximum turnaround time of 3 business days at a very competitive price of $185. 

At Adamson Analytical, we aim to be your go-to laboratory for all your testing needs.

 

Get in touch:

Tobias Wiezorek
CEO Tentamus California
+1 951 833 7277
tobias.wiezorek@tentamus.com

Source: https://www.tentamus.com/analysis-ndma-impurities-in-ranitidine/

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