The Open Drug Delivery Journal

2010, 4 : 14-20
Published online 2010 April 29. DOI: 10.2174/1874126601004010014
Publisher ID: TODDJ-4-14

Implementation Guidance for American Society for Testing and Materials (ASTM) E 2503-07 “Standard Practice for Qualification of Basket and Paddle Dissolution Apparatus”

Terry W. Moore , Michelle A. Long , William A. (Al) Kentrup , Mary D. Oates , Cheryl Kelley and Stephen P Sojkowski
Pfizer Vice President Quality Operations, Manufacturing & Supplier Quality Assessments –Collegeville, USA

ABSTRACT

This guidance is intended to serve as a companion document for ASTM Standard E 2503-07, “Standard Practice for Qualification of Basket and Paddle Dissolution Apparatus”, by providing practical information useful for the implementation of mechanical calibration. Particular focus is placed on use of the available tools to make the required measurements.

Keywords:

Dissolution, Calibration, Mechanical calibration, Calibrator tablets, ASTM standard, Instrument qualification.