Teva Uses the Agilent TRS100 to Achieve Regulatory Milestone for Content Uniformity Testing with the FDA
July 05 2022 - 8:00AM
Business Wire
Agilent’s unique technology for content uniformity workflow
creates a major customer impact
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.
About Agilent Technologies Agilent Technologies Inc.
(NYSE: A) is a global leader in the life sciences, diagnostics, and
applied chemical markets, delivering insight and innovation toward
advancing the quality of life. Agilent’s full range of solutions
includes instruments, software, services, and expertise that
provide trusted answers to our customers' most challenging
questions. The company generated revenue of $6.32 billion in fiscal
2021 and employs 17,000 people worldwide. Information about Agilent
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Catherine Kaye European PR Manager Agilent Technologies
Catherine.kaye@agilent.com T: 07775 410632 | www.agilent.com
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