Analytical

Tablet Dissolution Test Apparatus DS 8000 (Basic)

DISSOLUTION TEST APPARATUS

Dissolution Tests are conducted to determine the drug release patterns, physiological availability and bioavailability of for mulated drug products. It is also used as a quality control tool. The Dissolution rate of a drug from the solid state is defined as the amount of drug substance that goes into solution per unit time under standardised conditions of liquid / solid inter face, temperature, and solvent composition.

LABINDIA brings to you the State-of-the-art Dissolution Testing Apparatus in elegant design with advanced features, which supports USP 1, 2, 5 & 6. Apparatus for Intrinsic test & stationary basket methods are available.

STANDARD FEATURES

 

• Advanced, Micro-Controller based: User-friendly, complies with current USP , IP & EP specifications.

• Splash waterproof keyboard: Alphanumeric polyester soft keys for keyboard.

• Moulded water bath with 6+2 (3+1 & 3+1) vessel configuration enables comparative studies.

External vibration free Water Circulator: for uniform water circulation, with audible, low water level alarm, with indication on display for safety.

• 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. (Optional)

• Low Evaporation Lids:

» The conical shape low evaporation recovery lids reduces media loss during long run.

» Integrated pre-centered lids; no manual removal or positioning of lids. This ensures automatic vessel centering and precise positioning of paddle/basket with shaft without any special tool as per pharmacopeia requirements.

• State-of-the-art design:

» Easy placement and locking of vessels, the Ease-align system allows the vessels to simply slide into the place (Bionet Locking). Once placed, vessels do not float even when empty.

» Facility to monitor Vessel temp., with DTS Technology (Digital Temperature Sensor)

 

REGULATORY COMPLIANCE:

• DS 8000 meets all requirements relating to validation, qualification and calibration.

• Appropriate qualification documents (I.Q. / O.Q.) can be supplied with the instrument.

ADDITIONAL FEATURES (OPTIONAL)

• 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.

REPORTS

Selectable Report Format, complying with GLP requirements.

RUN REPORT

a) Report giving Run No., Set parameters and Actual parameters during the dissolution process.

b) Diagnostic functionality report to ensure proper working of the system

c) Printout of each vessel temperature and paddle/basket speed at every sampling time point for validation.

d) Validation report for Temperature & RPM

 

TYPICAL SPECIFICATIONS

• Control: Micro controller based (Advanced version of microprocessor).

• Display: 40 x 2 line back lighted liquid crystal display (LCD)

• Keyboard: Alphanumeric splash waterproof polyester soft keys.

• Method Storage: 15 programs with parameters.

• Data Storage: Available with Non-Volatile memory.

• Water Bath: 17 litres capacity with built-in water level sensor / Front located drain tap for easy draining of the water bath.

• Bath Circulation: External vibration free water circulator

• Temperature Range: 20°C to 55°C

• Temperature Resolution: 0.1ºC

• Temperature Control Accuracy: up to 45°C ±0.1°C & >45°C up to 55°C ±0.2°C

Temperature Sensor: DTS - Digital Temperature Sensor

• Paddle/Basket Shaft Speed: Range 20 to 250 RPM ±1%

• Dissolution Vessel: option for Polycarbonate / Glass Vessels (clear, amber, peak vessels, 250, 150 & 100 ml dissolution vessels available)

• Sampling Time Selectivity: Fixed/Programmable (varying intervals)

• Time Interval Selectivity: In steps of 1 minute

• Maximum Number of Intervals: 30

• Dissolution Process Time: 1 min. to 720 hours

• 6 Channel Temperature Reader: Optional - with Temperature Reader

 Report Format: a) GLP & Pharmacopeia compliant b) Program parameter report

 Output:

a) Printer: Compatible for deskjet, inject and dot matrix printer with parallel port

b) RS232C: For PC Connectivity

c) 21 CFR Part 11 compliance software available (optional)

• Power: 110 / 220 V AC - 50 Hz / 60 Hz

• Environmental Operating Conditions: a) Operation: Indoor. b) Temperature: Ambient to 45ºC. c) Humidity: 5 to 90% non-condensing.

• Dimensions: 71.5 x 60 x 70.5 cms. (W x D x H)

• Weight: 80 kgs. approx.

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