Pharmaceutical Analysis Using UV-Vis: Compliance with USP Chapter <857>, and Ph. Eur. 2.2.25

Meeting the requirements of the global pharmacopeias with the Agilent Cary 3500 UV-Vis:  The United States pharmacopeia (USP) and the European pharmacopeia (PH. Eur) guidelines describe how to verify that the analytical performance of UV-Vis spectrophotometers is suitable for the intended operational range of the analysis. Within Cary UV Workstation software for the Cary 3500, a range of system verification tests are available and automated. These tests align with the pharmacopeia requirements, while allowing the flexibility to cover a custom test list. USP general chapter <857> and Ph. Eur. chapter 2.2.25 guide instrument operational qualification protocols for UV-Vis spectroscopy.

The Cary 35000 UV-Vis spectrophotometer also offers a comprehensive software package to help achieve compliance with 21 CFR Part 11 and EU Annex 11. This software product helps achieve data integrity and traceability for all electronic records associated with the operation of the Cary 3500 UV-Vis spectrophotometer, including the system verification application used to perform the instrument performance tests described in the technical note

It is critical for pharmaceutical laboratories to ensure that their UV-Vis spectrophotometer is performing as required to meet the QA/QC measurement needs it is being used for. The global pharmacopeia prescribes how to test the intended operational range of the instrument, and these tests are conveniently automated in the Cary UV Workstation software. By simply and easily performing the system verification tests with the Cary 3500, a laboratory can readily confirm their instrument performance.

Download the application note to view the details.

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