Analytical Method Development

Jul 18, 2012
Equipment and Processing Report
By Pharmaceutical Technology Editors
We have developed an in-house broth to neutralize a preservative for traditional microbiological testing following USP <61> Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests. We would like to use a rapid method to release product faster, but is there a broth that will be effective on our products?
Jul 02, 2012
Pharmaceutical Technology
IQ Consortium representatives explore industry approaches for applying GMPs in early development.
Sep 02, 2011
Pharmaceutical Technology
By Pharmaceutical Technology Editors
Might European officials reverse their position on acceptable production methods?
Jun 15, 2011
Equipment and Processing Report
By Pharmaceutical Technology Editors
Two popular methods for detecting protein aggregates are analytical ultracentrifugation (AUC) and size-exclusion chromatography?multiangle light scattering (SEC?MALS). These techniques? results correlate relatively well, but each one has its own strengths.
May 18, 2011
Equipment and Processing Report
By Pharmaceutical Technology Editors
Recent recalls, including that of American Regent?s caffeine and sodium benzoate injection on May 5, 2011, highlight the importance of particulate inspection, and they might lead observers to ask whether current inspection methods are sufficiently effective.
May 01, 2011
Pharmaceutical Technology
The authors developed automated equipment that uses functionally closed disposables to perform cellular and ribonucleic processing.
Feb 02, 2011
Pharmaceutical Technology
A roundtable moderated by Angie Drakulich.
Nov 02, 2010
Pharmaceutical Technology
By Pharmaceutical Technology Editors
The author examines the process of method development, with reference to ISO 13320:2009 and relevant monographs from the United States and European pharmacopoeias.
Aug 02, 2010
Pharmaceutical Technology
By Pharmaceutical Technology Editors
The author reviews test methods for microbiological cleaning processes and suggests ways to improve microbial bioburden method suitability studies.
May 02, 2010
Pharmaceutical Technology
A method for determining sample size is finally getting some respect.
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