An online dissolution monitoring test – application sample
While the Spectra is price competitive with on-line sipper-based systems, it is free of the well-known problems associated with clogged filters, kinked lines and pump maintenance. The Spectra offers real time data collection and the high data density which provides a much greater level of statistical confidence in the dissolution measurements. Since the fiber optic probe remains in the solution throughout the dissolution test, no operator involvement is required. Up to 8 dissolution vessels may be monitored simultaneously within an extended UV-Vis range between 200-700 nm. A xenon lamp provides consistent, stable light output suitable for sustained release applications lasting many weeks or months.
The Spectra is rapidly set up, requires minimal operator involvement during the run, provides real-time data display and is nearly maintenance-free. It is used with all major dissolution baths including Pharma-Test, VanKel, Distek, Hanson, Erweka, Logan and Sotax. Spectra will help you conduct dissolution studies faster, with lower overhead costs, and the peace of mind that in situ, fiber optic monitoring provides.
The Spectra also easily accommodates high amounts of turbidity. Turbidity or light scattering from excipients in dosage forms, interferes with the accurate measurement of drugs in solution. The patented data processing algorithm effectively compensates for the spectral effects of turbidity.
A demonstration shows the dissolution of a tablet containing 200 mg caffeine in water. When 100% of the caffeine is dissolved, non-dairy coffee creamer is successively added to increase the turbidity. As the amount of coffee creamer increases, note that the dissolved caffeine remains at 100%. Under these conditions, direct spectral measurement without this patented algorithm would grossly overestimate the amount of caffeine in solution.
Specifications
4- 8 channels
200-700 nm effective range
Long life Xe source lamp
Dissolution datapoints up to twice per minute
Durable stainless steel dip probes with variable path lengths of 1, 2, 5, 10 or 20 mm.
Linear range up to 1.5+ AU.
The in situ UV monitoring supersedes traditional HPLC or flow-injection systems by eliminating the problems of operator error, complicated mechanical sipping devices, clogged filters, sample adhesion to tubing walls, wasted bench space, expensive consumables and clean-up. We pipe the light, not the liquid! Equipped to collect data from the very start of the experiment to several days later, the Rainbow monitor is ideal for both rapid-release and extended release solid dosage forms.
Small, Clean, Quiet
The Rainbow fits nicely on your lab bench right next to the dissolution bath. Since the Rainbow pipes the light and not the liquid, it does not generate any waste of its own. In fact, the only cleaning required is a quick rinse of the probes. Using the accompanying Indigo™ software, the Rainbow is easy to operate, requiring almost no maintenance, as there are no moving parts in the system.
UV in situ Dip Probes
The Rainbow utilizes dip-type UV probes (6 to 8 per monitor) to measure the amount of active pharmaceutical ingredient (API) released from a solid dosage form. These probes are suspended at the USP sampling position in the dissolution vessels and reside in situ for the duration of the test. Constructed of stainless steel, the probes have interchangeable quartz mirror tips offering path lengths of 1, 2, 5, 10, and 20 mm. The probes are sturdy, durable, and may be used in most dissolution media and all baths.
Security in the QC Environment
For GMP and QC environments, adds a full suite of security tools commonly employed in GMP and 21 CFR Part 11 laboratories.* These include secure user access, audit trails, digital signatures, data security and secure reporting.
Photo Diode Array Spectrometers
The system uses a bank of Zeiss MMS UV spectrometers interfaced to the dip probes for optical sampling; no material is removed from the bath. This allows very rapid acquisition of a full UV spectrum from 200 nm to 720 nm, in steps of 2 nm, from all vessels. In the case of a controlled-release formulation, a typical system configuration might sample every 20 minutes for 24 hours. For an immediate-release formulation, samples may be taken as frequent as every second. Watch the compound dissolve in real time.
The precision of the instrument exhibits excellent analytical performance in the range of 0.001 to 2.0+ absorbance units. The low thermal expansion properties of the titanium body virtually eliminate drift due to ambient temperature fluctuations. The patented design of the MMS-UV spectrometer eliminates moving parts and ensures high wavelength accuracy and precision (observed annual drift of less than 0.1 nm).
