Analytical Method Development

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.
Nov 02, 2004
Pharmaceutical Technology
This article provides guidance for minimally acceptable method validation practices and a foundation for assessing the risks and benefits associated with method validation programs.
Sep 02, 2004
Pharmaceutical Technology
By Pharmaceutical Technology Editors
A straightforward approach reveals how the probability of passing the USP content uniformity test can be calculated for tablets and capsules.
Sep 01, 2004
Pharmaceutical Technology
By Pharmaceutical Technology Editors
FDA recently approved the first PAT applications for the introduction of rapid microbial testing of drug products and pharmaceutical-grade waters. Officials from FDA and GlaxoSmithKline worked together to ensure the appropriate scientific evaluation of the methods. Team members report on the successful validation approach and identify technical issues to be considered for the future.
Jun 01, 2004
Pharmaceutical Technology Europe
This article introduces the application of high-resolution ultrasonic spectroscopy (HR-US) for the analysis of emulsions and suspensions. The authors outline the principles of the technique and illustrate its application for analysis of the crystallization of lysozyme and the formation of a microemulsion.
May 02, 2004
Pharmaceutical Technology
By Pharmaceutical Technology Editors
The author describes a separation method for two active ingredients in the contraceptive pill with liquid chromatography UV detection.
Feb 01, 2003
Pharmaceutical Technology
By Pharmaceutical Technology Editors
Analytical methods development and validation play important roles in the discovery, development, and manufacture of pharmaceuticals. The official test methods that result from these processes are used by quality control laboratories to ensure the identity, purity, potency, and performance of drug products.
Dec 01, 2002
Pharmaceutical Technology Europe
Spectroscopy using light is a familiar technique and the electromagnetic spectrum from UV to IR is routinely employed. This article looks at the advantages and applications of spectroscopy using sound waves, with special reference to pharmaceutical research.
Nov 01, 2002
Pharmaceutical Technology
By Pharmaceutical Technology Editors
An all-electronic validation can provide storage costs savings and ensured document legibility.
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