Teva Uses the Agilent TRS100 to Achieve Regulatory Milestone for Content Uniformity Testing with the FDA
Agilent’s unique technology for content uniformity workflow creates a major customer impact
SANTA CLARA, Calif.--(BUSINESS WIRE)--Agilent Technologies Inc. (NYSE: A) announced today that the FDA has approved a content uniformity (CU) method using the Agilent TRS100 Raman quantitative pharmaceutical analysis system.
The submitting company, Teva Pharmaceutical Industries Ltd., is an Agilent Raman spectroscopy customer and global leader in generic and biopharmaceuticals. In 2021, the U.S. Food and Drug Administration (FDA) approved the company’s CU method application, which was developed using the TRS100 system.
Content uniformity testing is one of several mandatory batch release quality control checks. Determining how much active pharmaceutical ingredient (API) is inside a tablet or capsule, and whether the API is uniform across a batch, is important for quality metrics. Spectroscopic technologies, such as the TRS100, present a fast, whole sample analysis, negating the sample preparation stages, to complete the test in a matter of minutes.
“The FDA approval of a TRS100 method for content uniformity testing by Teva is a great achievement for Teva, as well as for Agilent, and a key milestone for the product itself,” said Geoff Winkett, vice president of Agilent’s Molecular Spectroscopy division. “Teva joins other customers who have adopted this technology for CU testing for all the benefits it brings. It is a substantial investment to change manufacturing and QC processes, and an FDA approval minimizes the perceived risk of adopting this new technology.”
The approval of this CU method using the TRS100 is specific to Teva.
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