The FDA has reported on the detection of an impurity known as N-nitrosodimethylamine (NDMA) in common heartburn medications (ranitidine, commonly known as Zantac, and nizatidine) available over the counter or by prescription.
The FDA also launched an investigation to understand the cause of this impurity in these medications and to provide information to clinicians and customers who take them. As part of this inquiry, the FDA asked manufacturers to conduct their own laboratory tests to test the levels of NDMA in ranitidine and nizatidine and to give us samples to be examined by their own FDA scientists.
On December 4, 2019, the FDA announced that they have asked manufacturers of ranitidine and nizatidine products to expand their testing for NDMA to include all lots of the medication before making them available to consumers. If testing shows NDMA above the acceptable daily intake limit (96 nanograms per day or 0.32 parts per million for ranitidine), the manufacturer must inform the agency and should not release the lot for consumer use. (Source link: FDA.gov)
Impact Analytical Can Test Your Pharmaceuticals Now!
Impact Analytical is available for your testing needs. We can test your heartburn medication product utilizing the GC/MS Headspace Method posted by the FDA.
Our state-of-the-art GC-MS capabilities allow for detection of analytes to trace levels. We utilize both purchased (NIST) and in-house spectral databases to identify unknowns. Our equipment is qualified for testing under cGMP or GLP (FDA, EPA) guidelines if needed.
Contact us now to discuss your needs and to obtain a quote. We can help!
Techniques used for the process
Most impurity analyses will require some separation of components within the sample. Advanced instrumentation available at Impact Analytical can be used to separate sample components and to identify the impurity. Our instrumentation includes LC-MS, GC-MS, NMR, FT-IR, ICP, and several other instruments. LC-MS can provide accurate mass information on less volatile impurities, which leads to a timely structural assignment. LC-MS can also detect compounds without UV chromophores that would not be detected by HPLC-UV. GC-MS can detect more volatile components. Other techniques mentioned above can also be used for the identification once the impurity has been isolated. Only the most appropriated techniques will be used for the project, helping you to manage the cost of the project.
Impact Analytical will communicate with you during the analytical process to ensure that your project objectives are met. Throughout the project you will be able to determine whether or not your needs have been satisfied and to determine if additional testing is required to satisfy your needs. A quality identification of the impurity of interest will be the end product of our testing.
Rush and expedited testing services also available. Ask us how.