Dissolution Tester DS 14000 with Peristaltic Pump
Tablet Dissolution Test Apparatus

For high through put the tablet dissolution tester DS 14000 with peristaltic pump is a perfect solution for dissolution testing. Conforming to the latest USP, EP, BP, IP standards. The paddles, baskets and shafts are serialised for traceability.

The Alpha numeric keypad of the dissolution tester helps in the easy control of the entire dissolution apparatus. The efficient and versatile 24 channel peristaltic pump of Swiss make Ismatec transports samples from the dissolution vessels to the sample collector with high accuracy. Click n Go cassette design ensure longevity of the tubings and sample accuracy.  

User can perform dissolution testing using two buffers for application like enteric coated tablets.

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Standard Features of DS 14000 with Peristaltic Pump
  • User-friendly, complies with current USP, IP, BP, IP & 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 12 dosage form at single instance.
  • The conical shape low evaporation recovery lids reduces media loss during long run.
  • Facility to monitor Vessel temp, with DTS Technology (Digital Temperature Sensor)
Additional Features
  • Facility to RINSE the entire sampling path in between sampling time points to reduce 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 Sampling tubes are lowered in the media only at the time of sampling and withdrawn immediately after sampling, thus no par t of the assembly contributes motion, agitation or vibration.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 surface of media and the top of paddle/basket parameters, not less than 1 cm from the vessels wall as selected in the method.
  • 12 bowls temperature monitoring system automatically measures and records the temperature of individual vessel at specified sample points.
Peristaltic Pump
  • Imported Pump with click-n-go Cassette design for volume accuracy.
  • Fixed length pump tubings with stopper for sampling volume accuracy.
  • Volume calibration through software.
  • Tygon pump tubings for SLS Compatibility with long life.
  • Imported Pump with Planetary drive for very accurate pumping.
  • High repeatability on all Channels.
  • 24 actively driven stainless steel rollers.
Sample Collection
  • 12 X 6 X 2 sets of samples can be collected. For more sampling interval, 24 X 6 collection trays are available.
  • Option of 1.5ml & 2ml HPLC vials is available.
  • Over Head Design for electronic safety and fail safe operation.
  • Sensor to locate proper position of tray with alar m facility for collection of sample Wide mouth vial to minimise SLS spill over problem due to foaming characteristics
  • Easy positioning with respect to vials or test tube tray for easy changeover
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 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.
Regulatory Compliance
  • DS 14000 with Peristaltic Pump meets all requirements relating to validation, qualification and calibration.
  • Appropriate qualification documents (I.Q. / O.Q.) can be supplied with the instrument.
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

Dissolution Tester