Dissolution Tester

 

The tablet dissolution tester features a circular design that provides completely uniform water temperature. The Direct-Center™ automatic centering mechanism provides guaranteed positioning of the dissolution vessels and drive shafts for accurate dissolution tests with high reproducibility. All components are controlled by Spectra Manager™ (or CFR) for simple  operation.


System Features

  • Complies with GLP/GMP, and USP, EP and JP requirements
  • 21 CFR Part 11 compliant
  • Excellent temperature stability using a circular bath
  • Uniform temperature distribution between vessels
  • Easy set up and maintenance
  • Direct-center vessel centering for automatic alignment of vessels and drive shafts
  • Test vessels manufactured with precise tolerances for vessel dimensions
  • Spectra Manager™ Suite for operation and monitoring
  • Automated tablet dropping system for dosage loading
  • Automatic sampling tube positioning for upper and lower positions
  • Amber bath & vessels for light-sensitive samples

System Lineup

Flow System

This system integrates the DT-810 with an 8-position flow cell accessory and a UV-Vis spectrophotometer. A peristaltic pump (LH-PV3) continuously circulates sample solution between the 8 dissolution vessels and the flow cell accessory. Absorbance values are measured at user declared intervals and dissolution rates are automatically calculated. External samples can also be introduced for analysis.

Fraction System

This system integrates a fraction collector and the LH-PV3 pumping unit for off-line testing. As many as 12 sets of samples with a volume of 20 mL or less can be collected from each dissolution vessel at pre-set intervals. Additional flow lines for solvent refills or line flushes using internal or external volumes are available.

Fraction Flow System

This system combines the fraction collector and a flow cell installed in a UV-Vis spectrophotometer. Samples from the dissolution vessels are collected in test tubes using the fraction collector and sample aliquots are analyzed by the UV-Vis using the autosampling capability of the fraction collector. Residual sample volumes can be analyzed later using other techniques such as HPLC.

Automated Filtration System

This system includes the LH-SV8 8-position syringe pump and the AF-801 Automated filter changer. It provides automatic filtration of a maximum of 20 ml of sample solutions from all 8 vessels using 25 mm diameter membrane filters with a pore size of 0.45 micron (0.2 micron-optional). After each sampling, filters are automatically exchanged. The dedicated software can fully automate the dissolution testing including sample filtering.