This document describes the application of Agilent 8453 UV-visible spectrophotometer in pharmaceutical analysis, including its compliance with GLP regulations and superior optical performance.
The Agilent 8453 UV-visible spectrophotometer is designed for pharmaceutical analysis, offering solutions that ensure compliance with European Pharmacopoeia (EP) and United States Pharmacopeia (USP) requirements. It features a 1024-element diode array and prealigned light sources for trouble-free maintenance. The instrument supports GLP regulations through serial numbers, firmware revisions, and built-in electronic logbooks for self-test results and maintenance notes.
The system provides a wide wavelength range of 190-1100 nm with high throughput optics and exceptional ruggedness. It includes built-in buttons for convenient sample, standard, and blank measurements, even when wearing gloves. The Agilent UV-visible ChemStation software allows for electronic records and signatures, supporting FDA 21 CFR part 11 requirements for closed systems.
| Wavelength range | 190-1100 nm |
|---|---|
| Slit width | 1 nm |
| Wavelength accuracy | <+0.5nm |
| Photometric accuracy | <+0.005A |
| Photometric noise | < 0.0002 A |
| Typical scan time | 1.5 second |
| Weight | 16.5 kg |
| Line voltage | 90-264 V AC |
Yes, the Agilent 8453 supports compliance with GLP regulations through serial and firmware revision numbers held in firmware and extensive self-test procedures.
The Agilent 8453 uses the Agilent UV-visible ChemStation software in combination with Windows.
Yes, the Agilent UV-visible ChemStation software can be configured to support the requirements for electronic records and signatures for a closed system as defined in FDA 21 CFR part 11.