Drug dissolution tester

he DRC-6D drug dissolution tester complies with the 2015 edition of the Chinese Pharmacopoeia and complies with the Food and Drug Administration's Guideline for Mechanical Validation of Drug Dissolution Apparatus. In line with current Chinese GMP regulations. The instrument is in the form of an eight-cup, six-blade built-in electric lift structure. The newly designed electrical control and operating system are powerful, easy to operate and stable in performance.

Main Specifications:

   Level: inclination ≤0.5° (measured in two vertical directions after installation)

   Basket paddle (axis) verticality: ≤0.5° from the vertical direction

   Dissolution cup verticality: ≤1° deviation from the vertical direction

   Coaxiality of the vessel and the basket (paddle) axis: off-axis ≤1.0mm

   Basket (paddle) shaft swing: swing ≤ 0.3mm

   Basket swing: swing ≤0.5mm

   Basket (paddle) depth: 25 ± 1mm

   Basket (paddle) shaft speed error: <±4%

   Medium temperature in each vessel: 37oC ± 0.3 oC

   Vibration: ≤0.1mil

   Speed ​​range: 25-250 rpm

   Speed ​​accuracy resolution: 0.1 rev / min

   Water bath temperature range: 5oC (room temperature) -50oC

   Temperature display resolution: 0.01oC

   Temperature control accuracy: ≤ ± 0.3oC

   Cumulative time: 99 hours, 59 minutes and 59 seconds. (Basic experiment timing)

   Program-controlled sampling times: 1-24 different sampling periods can be preset.

   Sampling cycle time: arbitrarily set for 99 hours and 59 minutes per cycle, 24 sampling cycles can be counted down in stages, or continuous countdown.

   Print interval setting: ≤ 1-60 minutes

   Continuous working time: 100h

   Working noise: <60db

   Working environment: 5-35oC relative humidity; ≤80%

   Electric heating power: 1500W

Instrument structure and features:

   DRC-6D adopts high-resolution color touch screen, which is convenient and quick to operate, precise in control and friendly in human-computer interaction interface. Users can enjoy intelligent operation according to the screen prompts.

   DRC-6D dissolution apparatus adopts high head structure design form; the space between the lower edge of the machine head and the water tank is larger than the conventional model. Conducive to drug administration, sampling or rehydration operations, and easy access to the dissolution cup.

   DRC-6D provides user management permission function, setting two program entries of administrator account and general account. Enter the general account and perform routine repetitive testing operations. Log in to the administrator account to enter the system through password identification, and perform various parameter settings and actual operations.

   Dissolution cup and water tank have no gap design to ensure automatic center positioning. Eliminate system errors.

   The instrument provides “basic test” and “program test” options. The basic test function can change the test parameters at any time as needed to facilitate research tests. The program test function can perform 16 sets of preset test procedures, which is convenient for routine repeatability tests.

   The instrument provides intelligent temperature correction function, which allows users to perform temperature calibration and calibration through interactive operation easily, simply and reliably.

   The operation monitoring interface of the instrument provides users with 7 real-time data display windows; real-time temperature display, real-time display of speed, cumulative timing display, current waiting sampling times, current “n” sampling time, waiting for the current “n” The remaining time of the sub-sampling (countdown), the current "year, month, day", and "hour, minute, and second" are displayed.

   The instrument provides a standard 232 output interface for an external printer. Print real-time test data such as time, temperature and speed during the test.

   You can choose to provide two kinds of operation interface in Chinese and English, one-button switching.

   The instrument provides timed shutdown and timed automatic warm-up function.

   The instrument provides Chinese characters, numbers and English editing functions. It can provide data such as test number, test name, test parameters and test method for print output.

   With self-test and automatic protection function, it can give a variety of fault alarm prompts and secondary overheat protection.

   DRC-6D built-in head electric lifting structure form, not only beautiful in appearance, but also can avoid the rust and corrosion of the lifting machine exposed to the air, and reduce the motion noise.

   Dissolution cup lid that prevents evaporation of the dissolution medium.

   The instrument complies with the 2015 edition of the Chinese Pharmacopoeia

   The instrument complies with the "Guidelines for Mechanical Validation of Drug Dissolution Apparatus"

   Provide 3Q documents and 3Q verification services and physical properties verification (mechanical verification) services of the dissolution apparatus according to user requirements.

Applicable standards:

Chinese Pharmacopoeia 2015 Edition

Current regulations of China GMP