automation of dissolution tests解散的自动化测试.pdfVIP

Journal of Automated Methods Management in Chemistry Vol. 25, No. 1 (January–February 2003) pp. 7–15 Automation of dissolution tests Rolf Rolli production batches cannot be released or have to be SOTAX AG Basel, Binningerstrasse 106, CH-4123 Allschwil, Switzerland .e- re-analysed. Out-of-specification results requiring addi- mail: rolf.rolli@sotax.ch tional testing and the preparing of reports to explain the variances have become a main issue for quality- Dissolution testing of drug formulations was introduced in the control laboratories. Therefore, automation concepts 1960s and accepted by health regulatory authorities in the 1970s offer the advantage of reproducible results and all re- Since then, the importance of dissolution has grown rapidly as have quired documentation including calculations, statistical the number of tests and demands in quality-control laboratories data and graphs on the press of the print button. The Recent research works lead to the development of in-vitro introduction of CFR 21 Part 11 and the request of the U dissolution tests as replacements for human and animal bioequi- Food and Drug Administration (FDA)