Double beam UV/visible spectrophotometer has been designed to meet a host of validation and regulatory requirements for traceability in analytical methods
The Digilab-Hitachi U-2800 is supplied in the UK by Lambda Advanced Technology and is available as a standalone instrument or with PC control.
The instrument features self-validation for GLP/GMP, and will also conform to European Pharmacopoeia and CFR 21 Part 11 requirements.
For GLP/GMP requirements, the U-2800 has a self validation facility which allows the instrument performance to be related to externally traceable standards. Eleven different fundamental instrument parameters which influence the quality of analytical measurements produced by the unit can be checked.
These include wavelength accuracy (using two different lamps), wavelength reproducibility, resolution, stray light, photometric accuracy, photometric reproducibility, baseline flatness, baseline stability and noise.
The U-2800 can also be used for any measurements that must be in compliance with the European Pharmacopoeia.
The instrument offers a maximum/minimum ratio of 1.6 for the measurement of 0.02% toluene in hexane.
This exceeds the minimum value of 1.5 required by the European Pharmacopoeia.
For PC-controlled versions of the U-2800, the well-established UV Solutions control software meets all current FDA 21 CFR Part 11 requirements for use in the pharmaceutical industry, and include facilities such as electronic signatures.
