Product/Service

Dissolution Testing Systems - AT7smart USP 1,2,5 and 6

Source: SOTAX Corporation
SOTAX Dissolution Testing Equipment is used by the Pharmaceutical industry to characterize the dissolution properties of the active drug, the active drug's release and the dissolution from a dosage formulation. SOTAX offers Manual Dissolution Tester, Semi-automated Dissolution Testing Systems, Fully automated Dissolution Testing System and the USP 4 Flow Through Cell Dissolution systems. WinSOTAX Advanced Dissolution Software, is a used to control all SOTAX's dissolution testing systems for a complete 21 CFR Part 11 Compliant testing environment.

Dissolution Testing Systems:

The AT 7smart USP 1,2,5,6 Manual Dissolution Tester is compliant with all pharmacopeia methods including USP Apparatus 1 (basket), Apparatus 2 (paddle), Apparatus 5 (paddle over disk), Apparatus 6 (rotating cylinder), Intrinsic Dissolution, Stationary basket and Mini Paddles/Baskets/Vessels. The USP 1,2,5,6 Manual has a compact design with built-in heater/circulator and staggered vessels for easy sample viewing. It also features, a fixed position shaft height built-in evaporation covers for autvessel centering, and it fully conforms to USP and ASTM Mechanical Calibration.

The AT 7smart USP 1,2,5,6 Semi-automated Dissolution Tester simultaneously takes samples, which are filtered and collected in a fraction collector, withdrawn using a robotic arm or simultaneously sampled and analyzed directly by UV or HPLC. SOTAX offers several different dissolution bath tester according to specific needs, such as:

  • AT 7smart On/Off-line is based on a combination bath-pump-fraction collector-spectrophotometer
  • AT 7smart with ASD is based on a combination bath-robotic arm
  • AT 7smart HPLC On-line is based on a combination dissolution bath-pump-transfer station- HPLC
  • SOTAX OPT-DISS™ is based on a combination bath- UV Fiber Optic system for fast in-situ measurements

    • The USP 1,2 Fully Automated Dissolution Tester is for multiple unattended tests, including media preparation and delivery, automated dosage introduction, automated sampling, filtering and sample analysis by UV, HPLC, or UVFO, and vessel cleaning. The operator would only load the samples and collect the dissolution reports. The test can be done with paddles on tablets, capsules in sinkers and pellets in cartridges or with capsules in baskets. The MultiDose G3 Automated Dissolution Testing system has advanced media handling capabilities with the flexibility to address most any method requiring media changes or modificiations.

    The USP 4 Flow-Through Cell Dissolution System has been designed as the Apparatus 4 instrument made to overcome potential challenges linked to method development for a variety of dosage forms. SOTAX offers a variety of USP 4 Flow-Through Cell Models, such as:

  • USP 4 On-line System
  • USP 4 Off-line Closed System
  • USP 4 Off-line Open System

    • WinSOTAX is the Advanced Dissolution Software which controls all the SOTAX dissolution testing systems. WinSOTAX has a wide range of functionalities which fully complies with FDA 21 CFR Part 11 regulations. It has On-line modules for UV/VIS spectrophotometric measurements with the most common spectrophotometers and calculation of concentration and percentage dissolved including statistical functions.

    Dissolution Testing Systems: