Drug dissolution tester

Main Specifications:

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

   Basket paddle (axis) verticality: ≤0.5° off vertical

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

   Coaxiality between the vessel and the basket (paddle) axis: Offset axis ≤1.0mm

   Basket (paddle) shaft swing: swing ≤ 0.3mm

   Basket swing: swing ≤0.5mm

   Depth of basket (paddle): 25±1mm

   Basket (paddle) shaft speed: ±4%

   Medium temperature in each vessel: 37oC ± 0.3 oC

   Vibration: ≤0.1mi1

   Speed ​​range: 25-250 rpm

   Speed ​​accuracy resolution: 0.1 rpm

   Water bath temperature range: 5oC (room temperature) -45oC

   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; can preset 1-24 different sampling periods

   Program-controlled sampling period: 99 hours and 59 minutes per cycle can be set arbitrarily, 24 sampling cycles can be counted down in stages, or continuous countdown.

   USB data download and printing interval setting: ≤1-60 minutes

   Continuous working time: 100h

   Working noise: <60db

   working environment; 5-35oC relative humidity; ≤80%

   Electric heating power: 1900W

Instrument structure and features:

   14 185mm high-dissolution cups, 12 paddles or blue can be installed.

   DRC-12DF adopts industrial grade high resolution color touch screen, 32bit 400MHz MCU, convenient and fast operation, precise control, friendly human-machine interface, users can enjoy intelligent operation according to the screen prompts.

   DRC-12DF 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.

   The dissolution cup and the 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 execute 16 preset program modes to facilitate 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 USB real-time information download and massive test data storage. Completely save all data for the test process. Support for audit trails. The instrument also provides a standard 232 output interface for an external printer. Print real-time test data such as time, temperature and speed during the test.

   The instrument provides two kinds of operation interface in Chinese and English, one button to switch.

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

   The instrument provides Chinese character, number and English editing functions. It can be used for USB storage or printout, and provides data such as test number, test name, test parameters, and test methods.

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

   The electric lift of the machine head.

   Dissolution cup cover to prevent evaporation of the dissolution medium.

   The vertical axis of the pulp bar, the basket and the vessel is automatically centered.

   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