Analytical Method Development

Aug 01, 2005
Pharmaceutical Technology Europe
The first part of this article introduced the basic features of Raman spectroscopy and presented some examples of its application in the pharmaceutical industry. This second part focusses on the technique's application as a PAT tool within the pharmaceutical manufacturing environment. FDA's PAT initiative has provided motivation to explore the application of 'new' analytical technologies to the pharmaceutical manufacturing process and Raman spectroscopy shows great promise. The strengths and weaknesses of the technique as a potential PAT tool are discussed together with some examples of how this works in practice in a pharmaceutical manufacturing environment.
Jun 01, 2005
Pharmaceutical Technology Europe
HR-US is a nondestructive technique with enormous potential for the analysis of materials and formulations used in the pharmaceutical industry.
Jun 01, 2005
Pharmaceutical Technology Europe
Detection and identification of different polymorphic forms is, therefore, important throughout the drug development and manufacturing process.
May 12, 2005
Pharmaceutical Technology
By Pharmaceutical Technology Editors
New Chemical Reaction Method Accelerates Indole Production
May 02, 2005
Pharmaceutical Technology
A newly developed software program transforms written SOPs for all required analytical method validation experiments into transferable automated templates, integrating individual activities and technologies under one platform.
Apr 02, 2005
Pharmaceutical Technology
The validation of alternative microbiological testing is an opportunity for a manufacturer to decrease the amount of time required for laboratory results.To properly validate these alternatives, a practitioner must first identify what is being studied. The regulatory effect on established product and process specifications and levels must be completely evaluated, as changing the method of analysis may well change the pparent number in the sample.
Apr 02, 2005
Pharmaceutical Technology
The authors propose a strategy for classifying and validating inprocess testing methods.
Apr 01, 2005
The validation of alternative microbiological testing is an opportunity for a manufacturer to decrease the amount of time required for laboratory results. To properly validate these alternatives, a practitioner must first identify what is being studied. The regulatory effect on established product and process specifications and levels must be completely evaluated, as changing the method of analysis may well change the apparent number in the sample.
Mar 01, 2005
Pharmaceutical Technology
The author describes strategies for analytical method development that are helpful in achieving quality by design and efficiency.
Jan 02, 2005
Pharmaceutical Technology
A swab-sampling method was developed for cleaning validation of a residual active pharmaceutical ingredient in samples collected after cleaning the sampling suite. A summary of the strategies and results of the method development is presented.
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