1、 Model Introduction

RC-6D intelligent drug dissolution tester is a high-precision, high head drug dissolution tester 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. Compliant with current Chinese GMP regulations. The instrument adopts an eight cup six paddle built-in electric lifting structure. The newly designed electrical control and operating system is powerful, easy to operate, and has stable performance.

2、 Working conditions

2.1 Safety Performance: Complies with the relevant provisions of China's pharmaceutical industry standards for dissolution testers

22 Working power supply: AC 220V ± 10% 50Hz ≤ 1200W

2.3 Environmental conditions: Room temperature 5-40 ℃, humidity ＜ 80%

3、 Technical indicators and characteristics

3.1 Eight cup six paddle, high head electric lifting.

3.2 Color touch screen, interactive interface, intelligent control.

3.3 System permission management: (Login method: username+password).

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

3.5 Working mode:

3.5.1 Basic tests; The timing is positive and can be paused or continued for the convenience of research experiments.

3.5.2 Program control test; Time is a countdown that can be pre-set and saved for easy routine repeatability testing.

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

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

3.8 Verticality of dissolution cup: Deviation from vertical direction ≤ 1 °

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

3.10 Basket (paddle) shaft swing: swing ≤ 0.3mm

3.11 Basket Swing: Swing ≤ 0.5mm

3.12 Depth of basket (paddle): 25 ± 1mm

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

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

3.15 Vibration: ≤ 0.1mil

3.16 Speed range: 25-250 rpm

3.17 Speed accuracy resolution: 0.1 revolutions per minute

3.18 Water bath temperature range: 5 º C (room temperature) -50 º C

3.19 Temperature display resolution: 0.01 º C

3.20 Temperature control accuracy: ≤± 0.3 º C

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

3.22 Programmable Sampling Times: 1-24 different sampling cycles can be preset.

3.23 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.

3.24 Printing time interval setting: ≤ 1-60 minutes

3.25 Continuous working time: 100h

3.26 Work noise: ＜ 60db

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

3.28 Electric heating power: 1500W

3.29 Net weight 75Kg

3.30 Dimensions: Length 650mm, Width 555mm, Height 600mm

4、 Instrument structure and characteristics:

4.1 The RC-6D dissolution apparatus adopts a high head structure design form; The space size between the lower edge of the machine head and the water tank is larger than that of conventional models. It is conducive to medication administration, sampling, or fluid replacement operations, and the retrieval and placement of dissolution cups are also easy and effortless.

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

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

4.4 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.

4.5 The instrument 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.

4.6 Two operation interfaces in Chinese and English, one click switching.

4.7 The instrument provides timed shutdown and timed automatic preheating functions.

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

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

4.10 RC-6D has a built-in electric lifting structure for the machine head, which not only has a beautiful appearance, but also avoids oxidation and corrosion of the lifting machinery exposed to air, and reduces motion noise.

4.11 The instrument complies with the 2020 edition of the Chinese Pharmacopoeia

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

4.13 Provide paid 3Q files and 3Q verification services, as well as dissolution instrument physical performance verification (mechanical verification) services according to user requirements.

Applicable standards:

Chinese Pharmacopoeia 2020 Edition

Current regulations of China GMP