Valsartan and Impurity Testing

Today’s medicines undergo a wide range of testing, scrutiny, and evaluation before they ever make their way to market. Often, these drugs can spend many years in research and development and never make it to public sale, for a variety of reasons. Once a drug is being manufactured, it will continue to undergo careful scrutiny. During the manufacturing process, it’s very important to maintain quality control standards and continue to make sure that these products are being produced in a safe manner.

With an emphasis on data integrity and careful evaluation being more important now than ever before, it might surprise you to know that a popular blood pressure drug, valsartan, has recently taken the spotlight.

Valsartan is a prescription medication used to treat high blood pressure and heart failure. As an angiotensin II receptor blocker, the drug works by relaxing blood vessels and making it easier for your heart to pump blood. Angiotensin is a naturally-occurring chemical in your body that narrows your blood vessels. By blocking this response, valsartan allows your heart to pump blood more easily. This receptor blocker makes valsartan a popular drug for treating heart problems and reducing the risk of death after a heart attack.

The U.S. Food and Drug Administration (FDA) issued a voluntary recall for some drugs containing valsartan in July 2018 due to an impurity that is known to be a probable human cancer-causing agent, also known as a carcinogen. Some generic versions of drugs containing valsartan have been recalled because they were found to contain N-nitrosodimethylamine (NDMA), a probable carcinogen.

What is NDMA? The Environmental Protection Agency’s technical fact sheet on NDMA provides a lot of information on the organic chemical. While it isn’t produced for commercial purposes, aside from research, NDMA can be produced as a by-product of a variety of chemical reactions. According to the EPA, NDMA can be a result of reactions that also contain “nitrogen oxides, nitrous acid or nitrite salts.”

NDMA has been listed as a probable carcinogen and has been linked to potential cancer in animal tests. It is listed as a “priority pollutant” by the EPA; however, no federal standard allowable levels have been established for drinking water.

The recall began when a manufacturer in China performed contaminant testing and found the presence of this probable carcinogen. A ‘probable carcinogen’ means that there is evidence that the substance can cause cancer in humans; however, conclusive evidence may not exist. NDMA is also listed as an extremely hazardous substance under the U.S. Emergency Planning and Community Right-to-Know Act.

Because it may likely cause cancer in animals–and therefore humans–drugs may be recalled if they contain NDMA.

NDMA can be detected using both gas and liquid chromatography–tests we often perform here at SGS PSI. We perform a wide variety of impurity testing on numerous products and substances. Our team of scientists are ready to meet and exceed expectations for all of your independent testing challenges.