July 1st 2025
The partnership was formed in September 2024 in response to increasing demand for aseptic filling technologies and processes.
Using Extrusion-Spheronization to Develop Controlled-Release Formulations of Azithromycin
February 2nd 2005Extrusion-spheronization and pellet compression are effective means of developing first-order kinetic, controlled-release drug delivery systems of azithromycin (AZI). The authors prepared, evaluated, and optimized AZI formulations and assessed the stability of the selected formulation under accelerated storage conditions.
Toward a Generic Approach for Stress Testing of Drug Substances and Drug Products
February 2nd 2005The Impurity Profiling Group reviews stress testing according to regulatory guidance documents. The authors emphasize what should be considered for late clinical phases and for registration application dossiers.
Comparison of EP "Heavy Metals" Test with USP "Conductivity" Test
January 2nd 2005Comparative studies of the US Pharmacopeia (645) "Conductivity" and the European Pharmacopeia "Heavy Metals" tests were conducted to demonstrate that the USP method can determine the presence or absence of heavy metals in process water samples.