Tablet Dissolution Tester DS 8000+ with Piston Pump & Automatic Filter Changer
Dissolution Testing

Dissolution testing is considered one of the most important Quality control test performed on pharmaceutical dosage forms. The Labindia dissolution tester DS 8000 can be configured with a piston pump and automatic filter changer. Main concern of analysts is sample filtration process after collection of sample. Hence to overcome this the dissolution tester along with the pump and filter changer was developed by Labindia to ease the dissolution testing procedure.

Automatic filter changer FC 08 is controlled by the Dissolution tester for sample withdrawal from 6, 7 or 8 lines. Any standard 0.45 micron syringe filters with 25mm diameter can be used. Upto 96 filters can be stored for uninterrupted sample filtering for 16 sampling points. Used filters are automatically removed and replaced with new ones.

FC 08 is used in conjunction with high pressure piston pump PP 08 with filtration down to 0.2 micron syringe filters for UPLC analysis.

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 Tablet Dissolution Tester DS 8000 with Piston Pump and Automatic Filter Changer
Standard Features of Dissolution Tester DS 8000+ with Piston Pump & Filter changer
  • User-friendly, complies with current USP , IP ,BP & EP and ASTM specifications. Alphanumeric polyester soft keys for keyboard.
  • External vibration free Water Circulator for uniform water circulation with audible and low water level alarm.
  • Mono shaft design with automatic adjustment for 25 mm depth setting with easy changeover between Apparatus I & II eliminates routine height validation as per USP.
  • Paddles, Baskets and Vessels are laser marked with serial numbers for traceability.
  • Tablet dispenser drops 6 dosage form at single instance.
  • Facility to monitor Vessel temp, with DTS Technology (Digital Temperature Sensor)
  • Easy placement and locking of vessels, the Ease-align system allows the vessels to simply slide into the place (Bionet Locking)
Piston Pump-PP08
  • Piston Pump - PP 08 is ideal for sample withdrawal from 6 ,7/8channels.
  • The Piston Pump - PP 08 with inert ceramic rotor overcomes all absorption issues.
  • Accuracy better than ±2%.(@10mL)
  • Rinse function for reducing carryover issues.
  • Surfactant Media Compatibility.
Filter Changer-FC 08
  • Automatic Filter changer FC 08 is Microprocessor controlled and designed to filter 6, 7, or 8 sampling lines simultaneously.
  • Accessory for Inline Filtering of Sample before collection through Syringe Filters
  • FC 08 is used in conjunction with high pressure LABINDIA Piston Pump-PP 08 with filtration
  • High Storage capacity – up to 96 filters at a time gives uninterrupted filtered sample collection for 16 Sampling Points.
  • Individual channel Sensors to ensure filters are in place.
  • Incase the syringe filter is missing, automatic switch-over of valves to collect unfiltered sample, with an indication in the printout
Software
  • Alphanumeric entries of Sample Name, Sample Number and Identification Number for authentication.
  • Built-in Real Time Clock (RTC) for date and time on display and on printout.
  • Daily Auto Incremented Run Number and factory entered CUSTOMER NAME with Instrument Serial Number on report printouts
  • Non-Volatile memory storage of 15 methods with parameters.
  • Two tier password protection of Admin and User
  • Reports can be obtained even after Resetting / Power off / Power failure conditions.
  • Error indication helps user to trace the problem.
  • Audible indication for ready state of instrument.
  • Validation Software to validate RPM, Temperature, sampling volume & replenish volume.
Regulatory Compliance
  • DS 8000+ with Piston Pump & Filter Changer meets all requirements relating to validation, qualification and calibration.
  • Appropriate qualification documents (I.Q. / O.Q.) can be supplied with the instrument.
Additional Features
  • Built-in Validation software.
  • Facility to RINSE the entire sampling path in between sampling time-point to eliminate contamination & carryover
  • Specially developed cleaning system to clean the entire sampling path after each run.
  • Facilities to perform the dissolution test using two buffers (Buffer changing) to cater the application of enteric coating tablets.
  • Recovery Test facility to study 100% Drug Dissolution.
  • Split & on-time interval
Intelligent Sampling System
  • Automated sampling as per USP Specifications. Sampling tubes are lowered in the media only at the time of sampling and withdrawn immediately after sampling, thus no part of the assembly contributes motion, agitation or vibration.
  • Sampling tubes are accurately moved to the USP sampling position i.e. a zone mid way between the sur face of media and the top of paddle/basket parameters, not less than 1 cm from the vessels wall as selected in the method.
  • 6 vessels temperature monitoring system automatically measures and records the temperature of individual vessel at specified sample points.
FAQs

1. Can I use a sinker when the USP monograph does not specify one?

Typically if a sinker is needed in a dissolution test the procedure will mention the fact. Where the use of a sinker is not specifically mentioned in the procedure, it is safest to assume that the use of sinkers would represent an alternative procedure.

2.How can I find the right filter for my dissolution procedure?

The right filter will not adsorb the analyte when the dissolution sample solution is filtered. A number of filter materials are available increasing the probability that a good match can be found. The adsorption of the analyte to the filter may be saturable, meaning that it can only adsorb a certain amount of the analyte. If that is the case, a specific discard volume of sample solution filtrate can be found that allows subsequent filtrate concentration to be representative of the concentration of analyte dissolved in the sample. Typically milliliter increments of filtrate are passed through the filter cartridge and collected separately. The response of the analyte is measured in each increment and compared with the unfiltered solution. The amount of discard is determined from the results.

3. What is the purpose of the PVT?

USP considers adherence to measurable dimensional and operational parameters to be a critical component of apparatus suitability. However, without a challenge to the apparatus demonstrating the ability to produce dissolution results from a standard material, mechanical qualification alone does not provide sufficient evidence that the apparatus is performing satisfactorily. Furthermore, the USP PVT relies on more than the reference standard material itself. The ranges for the geometric mean (GM) and the coefficient of variation (%CV) are an integral component of the PVT and are obtained from a multinational collaborative study conducted for each new lot of reference standard tablets. Those two statistics, GM and %CV, help the laboratory using the reference standard determine if their results are accurate within the context of ISO 5725-6, Accuracy (Trueness and Precision) of Measurement Methods and Results—Use in Practice of Accuracy Values. Accuracy is comprised of trueness and precision, which are embodied in the geometric mean and %CV, respectively. A discussion of these concepts can be found in an article by Walter Hauck, et al. in Pharmacopeial Forum 33(3), “Proposed Change to Acceptance Criteria for Dissolution Performance Verification Testing.”

4. Can I use peak vessels?

<1092> mentions peak vessels as noncompendial apparatus that may have some utility with proper justification.

5. Why aren’t the recommendations in the USP Dissolution Toolkit found ?

The USP Dissolution Toolkit contains enhanced mechanical calibration information. Agreement exists that additional controls can be imposed by tightening the mechanically measured attributes of Apparatus 1 and 2, insufficient data exists to determine the appropriate degree of change or that such tightening would necessarily improve the quality of the dissolution results obtained. Because the chapter is harmonized, any change to the description of Apparatus 1 or 2 would have to be agreed by the Pharmacopeial Discussion Group comprised of the European Pharmacopoeia, the Japanese Pharmacopoeia and USP. REF:USP.org

Tablet Dissolution Testers