The Spectra is the newest, next generation model in the Rainbow Dynamic Dissolution Monitor® family, which utilizes Pion's patented in situ technology and fiber optic probes. The instrument builds upon our experience in the design, development and manufacture of the Rainbow™ and µDISS Profiler™fiber optic instruments. Feedback from R&D and process control laboratories was an integral part of the development of this new instrument.
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.
As with the reliable Rainbow RDDM, the Spectra is also powered by versatile Indigo™ software, providing users with multiple functions in one flexible, easy-to-use, integrated system for method development. Furthermore, the IndigoSAM™ secure account manager software add-on to Indigo™ provides GMP and 21 CFR 11 compatibility for the quality control laboratory.
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 video 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
Spectra
- Up to 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.
Indigo™
- Flexible, user-friendly method development software
- Manual or automatic scanning control
- View all channels simultaneously in real time
- Up to six user-programmed experiment steps
- Data export to Excel
IndigoSAM™
- Secure account manager add-on to Indigo™
- Four levels of user security
- Data audit trail and data security
- Digital signatures
- Easy method import and lockdown from Indigo™
- Validation package available
For more details on the Indigo™ and IndigoSAM™ software, click here.
