Dissolution Tester DS 14000+ with Syringe Pump
Tablet Dissolution Test Apparatus

The tablet dissolution tester DS 14000 with syringe pump offers advanced features as a complete dissolution offline sampling system. 12 port Multi syringe pump system with proprietary high efficiency & maintenance free stepper motor drive enables testing for long duration.

15 methods with parameters can stored and the dissolution run can be started with the last run parameters. The configuration allows two different runs to be performed at the same time with identical conditions. In case of power failure the system restarts the run where it had left off.

100% USP, BP, EP, IP compliant and fulfils the specifications in accordance to the FDA mechanical calibration.

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Standard Features of DS 14000+ with Syringe Pump
  • 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 12 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)
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 Sampling tubes are lowered in the media only at the time of sampling and withdrawn immediately after sampling, thus no par t of the assembly contributes motion, agitation or vibration (500, 750, 900 & 1000 ml).
  • 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.
  • 12 bowls temperature monitoring system automatically measures and records the temperature of individual vessel at specified sample points.
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 spillover problem due to foaming Characteristics.
Syringe Pump
  • Multi-Syringe Pump system designed for automatic Sample Collection from Dissolution Bowls of Labindia Dissolution Test Apparatus DS 14000+.
  • Perform Rinsing the sample tubing path, Replenishing the blank media volume to bowls and Sample Dilution tasks (Optional for future development).
  • Controlled through Labindia dissolution Instr ument Controller with Operation Status Indications on the front panel for user information.
  • Inert fluid path consisting of Teflon carrier tubing, Gastight Glass Syringes with Teflon Plunger and PEEK body Valves.
  • Proprietary high-efficiency and maintenance-free Stepper motor drive system.
  • Long-life 4 port Rotary shear valves with SS Body.
  • Volume accuracy better than ±2%.
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 14000+ with Syringe Pump meets all requirements relating to validation, qualification and calibration.
  • Appropriate qualification documents (I.Q. / O.Q.) can be supplied with the instrument.
Typical Specification
Parameters
DS14000 with Piston Pump
DS14000 with Syringe Pump
Dissolution Vessel

Option for Polycarbonate / Glass Vessels (clear, amber, peak vessels, 250, 150 & 100 ml dissolution vessels available). 

Display

40*2 LCD Display (Alphanumeric)

RPM

20 to 250 RPM

RPM Accuracy

± 1 RPM

Temprature Range

20° to 55° degree

Temp Accuracy

± 0.1° C

Method

15

User 

10

Role

2 Role(Admin & User)

Connectivity

RS-232

Test Report

Last Report

21 CFR Compliance

Yes( EDC Software)

Auditrail

NA

E Signature

NA

Sampling Interval

30

Sample Interval Time

1min to 720 hrs

Pump Used for Sample Collection

Piston Pump

Syringe Pump

Sample Volume Range

0.5ml - 25ml

0.5ml-10ml

Rinsing

Rinse

Cleaning Cycle

Yes

Sample Collector Type

Open

HPLC Vials Tray

Yes

Option for 1.5ml & 2ml HPLC Vials

Auto Tablet Dispenser

Manual

Tray detection & identification

NA

Contact parts

All Contacts Parts are inert

Sample Collection

12*6*2 Sample Collection Tray Tray.(24*6 Optional)

12*6*2 & 24*6

Automatic Vessel Centering

Yes (Complies as per US FDA division of
pharmaceutical analysis (Ref. Document no.
DPA-LOP.002)

Center Shaft

± 0.5mm

Lift Mechanism

Motorized (Automatic) for accurate height

Heater

Isolated temperature controller (vibration-free & precise) with wake up & sleep modes (saves time & energy) (1KW)

Shaft

MonoShaft - Easy Switch Over between Paddle & Basket

Height Adjustment

Automatic height adjustment

Apparatus

Unique design of USP apparatus
I, II, V, VI & intrinsic dissolution can be used. Also Small Volume Dissolution kit 250ml & 150ml can be used.

Laser Marking on Accessories

Yes

Water Bath

Clear acrylic molded water Bath 

Water Level Sensor

Yes

Power Failure

Yes


LABINDIA reserve the right to change specification without notice as part of its continuous product development.

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