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Overview of Dissolution Instrument Qualification ...
Dissolution Technologies | MAY 20116e-mail: of Dissolution Instrument Qualification , including Common PitfallsGregory P. Martin1,* and Vivian A. Gray21 Complectors Consulting LLC, Pottstown, PA 194652V. A. Gray Consulting, Hockessin, DE 19707 INTRODUCTIONFor almost fifty years, the pharmaceutical community has been relying on Dissolution data as an indication of drug product performance (1). Effective qualifica-tion of the Dissolution apparatus is critical to the value and integrity of these of Dissolution instruments has always been challenging. Apparatus performance can be influenced by variability in several mechanical parameters. Data are affected by the physical and chemical properties of the drug product. Dissolution performance is also changing rapidly while the samples are collected. Recently there have been several significant changes in regulatory and compendial guidances related to the Qualification of these instruments .
6 Dissolution Technologies | MAY 2011 e-mail: greg.martin@complectors.com Overview of Dissolution Instrument Qualification, Including Common Pitfalls Gregory P. Martin1,* and Vivian A. Gray2 1Complectors Consulting LLC, Pottstown, PA 19465 2V. A. Gray Consulting, Hockessin, DE 19707 INTRODUCTIONF
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