USP-Compliant Online Dissolution Testing of Antipyretic Analgesic: Automatic Addition of Internal Standard

User Benefits

- Dissolution testing can be automated. - The automatic sampling function enables testing with good reproducibility. - The automatic dilution and the automatic addition of internal standard improve work efficiency.

Introduction

Dissolution testing is conducted for formulation development, quality control, bioequivalence tests of generic drugs, etc.. In dissolution testing, the dissolution properties of a drug product are checked under specific conditions for certain periods. Dissolution testing takes a lot of labor and time, since dissolution media must be sampled from multiple vessels every sampling time and analyzed. Nexera FV is an HPLC system for online dissolution testing. It can automate the processes from sampling dissolution media, HPLC analysis, up to report output. By automating tasks that used to be conducted manually by operators, the system realizes labor saving and throughput improvement. In addition, automating tasks prevent human errors from whole processes. This article introduces an example of automatic addition of the internal standard (ISTD) to the dissolution medium and a USP- compliant online dissolution testing of an antipyretic analgesic tablet using the Nexera FV. For additional information on online dissolution testing, please refer to Application News 01-00029 and 01-00031.

April 5, 2022 GMT