Tablet Dissolution Tester DS 8000 (Basic)
Tablet Dissolution Test Apparatus

With proven quality and technology the Labindia tablet Dissolution testers are built for simple dissolution testing with budget in mind as well. The tablet dissolution tester DS 8000 (Basic) is uniquely designed to support USP 1,2,5 & 6 and is compliant with currently USP, BP, EP, IP specifications.

The high head dissolution testing apparatus can be configured for 6,7 or 8 vessel configuration and the moulded water bath which has an outlet for easy cleaning. The external water circulator with heater is vibration free and ensures a constant temperature throughout the dissolution test run.

This makes the Dissolution tester DS 8000 a perfect entry level model for dissolution testing.

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 Dissolution Tester DS 8000
Standard Features of Dissolution Tester DS 8000 (Basic)
  • 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 (Optional) drops 6 dosage form at single instance.
  • The conical shape low evaporation recover y lids reduces media loss during long run.
  • Facility to monitor Vessel temp, with DTS Technology (Digital Temperature Sensor)
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.
Regulatory Compliance
  • DS 8000 (Basic) meets all requirements relating to validation, qualification and calibration.
  • Appropriate qualification documents (I.Q. / O.Q.) can be supplied with the instrument.
Additional Features
  • 6 Vessels Temperature Monitoring System automatically measures and records the temperature of individual vessel at specified sample time points.
  • Validation Software for RPM & Temperature.
  • Recovery Test facility to study 100% Drug Dissolution.
Typical Specification
Parameters
DISSO SMART 8000 Basic
DS8000 Basic
Dissolution Vessel

Option for Polycarbonate / Glass Vessels (clear, amber, peak vessels, 250, 150 & 100 ml dissolution vessels available). Also 2 litre Vessel Available

Option for Polycarbonate / Glass Vessels (clear, amber, peak vessels, 250, 150 & 100 ml dissolution vessels available). Also 2 litre Vessel Available

Display

7" Colour High Resolution Touch Screen Display

40*2 LCD Display (Alphanumeric)

RPM

20 to 350 RPM

RPM Accuracy

± 1 RPM

Temprature Range

20° to 55° degree

Temp Accuracy

± 0.1 ° C

6 Channel Temperature Reader

Yes

Method

1000

15

User 

250

10

Role

4 Role(Admin,Manager,Supervisor,Operator)

2 Role(Admin & User)

Connectivity

USB,LAN,WiFi,Bluetooth

RS-232

Test Report

10000

Last Report

21 CFR Compliance

Yes (Optional)

Yes( EDC Software)

Auditrail

Yes

NA

E Signature

Yes

NA

Sampling Interval

50

30

Sample Interval Time

1 Min to 1200 hrs

1min to 720 hrs

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

Yes

Water Bath

Clear acrylic molded water Bath 

Clear acrylic molded water Bath 

Water Level Sensor
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

Tablet Dissolution Testers