RC8DF drug dissolution instrument is a high-precision drug dissolution instrument developed and produced by Tianjin Chuangxing Electronic Equipment Manufacturing Co., Ltd. Compliant with the 2020 edition of the Chinese Pharmacopoeia and the Guiding Principles for Mechanical Validation of Drug Dissolution Testers issued by the State Food and Drug Administration. The instrument adopts an eight cup eight paddle four column support structure, which can simultaneously perform one batch of drug dissolution test, one blank test, and one standard test. The newly designed electrical control and operating system is powerful, easy to operate, and has stable performance.

Main technical indicators:

▓ Levelness: Tilt angle ≤ 0.5 ° (measured in two vertical directions after installation)

Verticality of basket paddle (shaft): deviation from vertical direction ≤ 0.5 °

Verticality of dissolution cup: deviation from vertical direction ≤ 1 °

Coaxiality between dissolution cup and basket (paddle) axis: deviation from axis ≤ 1.0mm

▓ Basket (paddle) shaft swing: Swing ≤ 0.2mm

Basket swing: Swing ≤ 0.5mm

Depth of basket (paddle): 25 ± 1mm

▓ Basket (propeller) shaft speed error: ＜ ± 4%

▓ Medium temperature in each dissolution cup: 37 º C ± 0.3 º C

Vibration: ≤ 0.1mil

Speed range: 25-250 rpm

Speed accuracy resolution: 0.1 revolutions per minute

Water bath temperature range: 5 º C (room temperature) -45 º C

Temperature display resolution: 0.01 º C

Temperature control accuracy: ≤± 0.3 º C

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

Number of sampling periods: 1-24 different sampling periods can be preset.

Sampling cycle time: 99 hours and 59 minutes per week can be set arbitrarily, and 24 sampling cycles can be counted down in sections or continuously.

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

▓ Continuous working time: 100h

Work noise: ＜ 60db

Work environment; 5-35 º C relative humidity;  ≤80%

Electric heating power: 1500W

Instrument structure and characteristics:

System permission management: multi-level, multi-user (login method: username+password).

Audit tracking records: Multi content, multi parameter long-term storage.

The RC-8DF adopts an industrial grade high-resolution color touch screen, a 32-bit 400MHz MCU, which is easy and fast to operate, precise in control, and has a friendly human-computer interaction interface. Users can enjoy intelligent operation according to screen prompts.

RC-8DF provides user level management permission function, setting up two program entrances: administrator account and general account. Entering a general account allows for routine repetitive testing operations. Login to the administrator account can enter the system through password recognition, perform various parameter settings and actual operations.

◎ The dissolution cup and water tank are designed with no gap to ensure automatic center positioning. Eliminate systematic errors.

The instrument provides options for "Basic Test" and "Program Test", and the basic test function can change the test parameters as needed at any time to facilitate research experiments. The program testing function can execute 16 pre-set testing programs, making it convenient for routine repetitive testing.

The instrument provides intelligent temperature calibration function, and users can easily, simply, and reliably complete temperature calibration and correction through interactive operation.

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

The instrument provides USB real-time information download and massive experimental data storage functions. Complete preservation of all data from the experimental process. Support audit tracking. The instrument also provides a standard 232 output interface that can be connected to an external printer. Print real-time test data such as time, temperature, and speed during the testing process.

The instrument provides two operation interfaces in Chinese and English, with one click switching.

The instrument provides a "message board" function, which can write and save text prompts or important notes for the incoming operators on the message board.

The instrument provides timed shutdown and timed automatic preheating functions.

The instrument provides editing functions for Chinese characters, numbers, and English. It can be stored or printed out via USB, providing data such as test number, sample name, test parameters, and test methods.

◎ It has self checking and automatic protection functions, and can provide various fault alarm prompts and secondary overheating protection.

◎ Electric lifting of the machine head.

◎ Dissolution cup lid to prevent evaporation of dissolution medium.

The instrument complies with the 2020 edition of the Chinese Pharmacopoeia

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

According to user requirements, we provide paid 3Q files and 3Q verification services, as well as dissolution instrument physical performance verification (mechanical verification) services.

Applicable standards:

Chinese Pharmacopoeia 2020 Edition

Current regulations of China GMP