Analytical Method Development

Sep 01, 2004
Pharmaceutical Technology
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
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
An all-electronic validation can provide storage costs savings and ensured document legibility.
Oct 01, 2002
Pharmaceutical Technology Europe
A limit test using ion mobility spectrometry (IMS) has the potential to dramatically reduce the time required for cleaning verification and cleaning method development. The traditional approach to cleaning verification, often using HPLC, is relatively resource intensive and can lead to significant delays in reporting results. The main advantage of IMS is that results are seen virtually instantaneously, so any necessary re-measurement can be done very quickly. If the results demonstrate cleanliness, production can resume in a matter of hours not days.
Aug 01, 2002
Pharmaceutical Technology
The author explains how a sponsor company can select and partner with a CRO for the redevelopment and revalidation of analytical test methods.
May 01, 2002
Pharmaceutical Technology
The authors subjected ibuprofen bulk drug and tablet assay preparations to various stresses to evaluate the selectivity and specificity of the drug substance and product samples.
Apr 01, 2002
Pharmaceutical Technology
Eventual change in the dissolution characteristics of some dosage forms, which is ascribed to cross-linking of gelatin, continues to present challenges to drug manufacturers. The authors discuss the causes, mechanisms, and solutions to the problem.
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