Generics
FDA Approves Content Uniformity Method using Agilent TRS100
5 July 2022 - - The US FDA has approved a content uniformity method using US-based Agilent Technologies Inc's (NYSE: A) TRS100 Raman quantitative pharmaceutical analysis system, the company said.

The submitting company, Teva Pharmaceutical Industries Ltd., is an Agilent Raman spectroscopy customer and leader in generic and biopharmaceuticals.

In 2021, the US Food and Drug Administration 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 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 approval of this CU method using the TRS100 is specific to Teva.

Agilent Technologies Inc. (NYSE: A) is in the life sciences, diagnostics, and applied chemical markets.

Agilent's range of solutions includes instruments, software, services, and expertise that provide trusted answers to our customers' most challenging questions.

The company generated revenue of USD 6.32bn in fiscal 2021 and employs 17,000 people worldwide.
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