N-nitrosodimethylamine (NDMA) Impurity Analysis in Valsartan Drug Substance by Headspace GC/MS

N-nitrosodimethylamine (NDMA) impurity analysis and testing in valsartan drug products according to the FDA Office of Testing and Research headspace gas chromatography-mass spectrometry (GC/MS) method

N-nitrosodimethylamine (NDMA) is an impurity potentially found in valsartan tablets and has been the driver for a recall by the FDA in July 2018 and the subseuquent need for analysis to detect and quantify the impurity. NDMA is classified as a probable human carcinogen and its presence in finished pharmaceutical products may be the result of the manufacturing process of the drug substance. The FDA Office of Testing and Research have developed a headspace gas chromatography-mass spectrometry (GC/MS-HS) method to detect and quantify the presence of NDMA in drug substance samples of valsartan at levels of  ≥ 0.3 ppm.

Intertek has established this method within our GMP laboratory services capability to assist clients in performing the required method validations where the data can be used to support regulatory submissions or quality assessment of the API or drug product. 

With scientists who are adept at method development and validation of suitable analytical procedures, we regularly help clients overcome the challenges of low detection levels, difficult matrices and identification of unknowns in the course of pharmaceutical impurities analysis. Additionally, we offer highly sensitive and specific method development and validation expertise to assess other carcinogenic or genotoxic impurities in drug products.

In addition to experienced pharmaceutical impurity analysis, we can support with toxicological risk assessments. Our experienced consultants conduct risk assessments to address the impact associated with exposure to residual solvents, process impurities, extractables & leachables, elemental impurities (ICH Q3D) and other substances that may find their way into a given pharmaceutical product.

 

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