[Seminar 3/15] Announcement of the Practical Seminar on Dissolution Testing

HIGUCHI INC.

We will be holding a seminar focused on mechanical calibration and data integrity (DI) in relation to dissolution testing of formulations, which has recently garnered significant interest. Mechanical calibration, newly included in the reference information of the 17th revision of the Japanese Pharmacopoeia, has become well-known as a qualification evaluation method using a different approach and is being implemented by many companies. Additionally, there has been a longstanding requirement for the data generated from each process to be complete, and specific guidelines, including draft versions, have now been provided by various countries and organizations regarding DI. This seminar will include demonstrations and explanations related to mechanical calibration. We will also cover an overview of DI and its relationship with dissolution testing. We hope that by attending this seminar, participants will find it helpful in terms of future implementation, resolving issues, and deepening their knowledge. Seminar Content: - Qualification evaluation of dissolution testing equipment - Differences in mechanical calibration content between the Japanese Pharmacopoeia and various organizations - Practical training on mechanical calibration - Information on data integrity - Introduction to the equipment we handle

Date and time Friday, Mar 15, 2019
10:30 AM ～ 05:00 PM
Capital Venue: Higuchi Shokai Co., Ltd. Osaka Branch, 1-20-13 Utsubo Honmachi, Nishi-ku, Osaka City, Naniwa-suji Building 8F Participation Fee: Free Capacity: 8 people Applications will be accepted through our company website. Please note that we will close applications once the capacity is reached. *This seminar is intended for measurement technicians. We kindly ask manufacturers and those attending for technical research purposes to refrain from participating.
Entry fee Free

Related product information

Dissolution Tester, compliant with the Japanese Pharmacopoeia, Agilent 708-DS
Corresponds to the Japanese Pharmacopoeia, USP, and EP3. The design minimizes mechanical variation factors of the device using vessels that reduce the deviation of the container's centering.

The precise and robust design, along with certified vessels, paddles, and baskets, supports tri-polar compatibility as well as compliance with FDA, ASTM, and JP17 reference information for mechanical calibration. The automatic tablet dispensing mechanism, automatic temperature monitoring, and automatic sampling mechanism, combined with the sampling station 850-DS, enable semi-automation of dissolution testing. Online analysis through the connection of a UV meter displays the dissolution rate in real-time. By selecting options tailored to customer applications, a wide range of device configurations from manual to automatic is possible.
Dissolution Tester Mechanical Calibration System 280-DS
JP17 Bureau Reference Information: Mechanical Calibration Correspondence for Dissolution Test Apparatus

Effects of introducing 280-DS MQS: - Shortened MQ tasks (2 days to 30 minutes) - Reduced calibration intervals, improving the reliability of test results - Equipment history can be investigated - Measurement results are automatically recorded from each module to the PC - Standard tablets such as prednisone are not needed