• Advance Micro – controller (Arm Core )User-friendly, complies with current USP , IP ,BP & EP and ASTM specifications.
• Mono shaft design with easy changeover between Apparatus I & II eliminates routine height validation as per USP.
• Automatic stirrer 25 mm depth positioning (as per USP )
• Vessels, paddles and Basket are Laser marked with serial numbers for traceability
• Automated Tablet dispenser drops 12 dosage form at single instance
• The conical shape low evaporation recover y lids reduces media loss during long run.
• Easy placement and locking of vessels, the Easealign system allows the vessels to simply slide into the place (Bionet Locking).
• Facility to monitor Vessel temp ,with an external Digital Temperature Sensor
• 7’’ Colour High resolution Display with touch screen interface
• External vibration free flow water circulator

• Audit Trail for all activities with search facility, report generation and printing.
• 200 and more User ID’s with alphanumeric entries of user name, password and role based privileges selection.
• Multi-level roles with password protection,expiry & complexity
• User authentication is per formed for each and every operation done by user.
• PDF report file can be created through print.
• Electronic signature functionality.
• Data Backup and Restore facility available.
• LAN (Ethernet) connectivity for Data backup on Network shared folder

• QWERTY Keyword for 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.
• Factory entered CUSTOMER NAME with Instrument Serial Number on report printouts
• Non-Volatile memory storage methods with parameters.

• DS 14000 SMART with Piston Pump meets all requirements relating to validation, qualification and calibration.
• Appropriate qualification documents (I.Q. / O.Q.) can be supplied with the instrument.

• 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

• 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 & records the temperature of individual vessel at specified sample points.
• Inert PTFE Fluoropolymer Carrier Tubing

• Piston Pump - PP 12 is ideal for sample withdrawal from12 channels.
• The Piston Pump - PP 12 with inert ceramic rotor overcomes all absorption issues.
• Accuracy better than ±2%(@10mL)
• Rinse function for reducing carryover issues.
• Surfactant Media Compatibility.

• 12 X 8 X2 sets of samples can be collected. For more sampling interval, 24 X 8 collection trays are available.
• Option of 1.5ml & 2ml HPLC vials 24*8 tray is available.
• Wide mouth vial to minimise SLS spillover problem due to foaming Characteristics
• Auto recognition sensor for tray with alarm facility for collection sample
• Easy positioning with respect to vials or test tube tray for easy changeover

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

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