Techniques - U/V Spetroscopy
UV is still the main method used to analyse the endpoint of dissolution tests. The use of fully or semi automated systems based on the Agilent 8453 UV-Visible Spectrometer, is a powerful tool for the dissolution laboratory Using a four bath Agilent 8453 UV-Visible Spectrometer system linked to four Distek 6100 Dissolution Baths, it is possible to complete, analyse and report over 30 dissolutions per day.
Omicron has extensive experience in set -up, qualification and maintenance of these systems. For support of compliance with the requirements for electronic records and signatures (21 CFR Part 11), the dissolution-testing mode can be combined with the Security Pack for UV-Visible ChemStations.
Omicron has recently introduced new piston pump technology options, which seamlessly integrate with all Agilent 8453 systems, for systems when peristaltic pumps are not suitable.
Fibre Optic UV Dissolution Testing
The Opt Diss Fibre Optic
UV Dissolution Testing system is
the latest
advancement in dissolution testing. Taking analysis directly into
the vessel where dissolution occurs eliminates the need for sample
removal. Fibre Optics brings improved precision and accuracy of test
measurements, while eliminating sampling errors and the requirement
for complicated media loss calculations.
The Opt Diss is ideally suited for use with most standard dissolution systems performing formulations development, quality control, and process monitoring tests.
Some feature highlights are:
- Unique G2 ARCHTM Probe Design provides full light transmittance across a horizontal path length without the need for mirrors or prisms.
- Low Disturbance Arch Probes contribute negligible hydrodynamic effects during a dissolution test, thus eliminating the need for a sampling manifold.
- Rapid Spectra Collection simultaneously collects the entire spectral from up to 12 vessels in a minimum of 5-second intervals, increasing accuracy and improving profile analysis.
Opt Diss Fibre Optic UV Dissolution Testing system's 21 CFR Part 11 Compliance offers the confidence and security required for todays strict controls and audit trail requirements.
