Analytical Method Development

HR-US is a nondestructive technique with enormous potential for the analysis of materials and formulations used in the pharmaceutical industry.

New Chemical Reaction Method Accelerates Indole Production

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.

The authors propose a strategy for classifying and validating inprocess testing methods.

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.

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.

The author describes strategies for analytical method development that are helpful in achieving quality by design and efficiency.

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.

This article provides guidance for minimally acceptable method validation practices and a foundation for assessing the risks and benefits associated with method validation programs.

A straightforward approach reveals how the probability of passing the USP content uniformity test can be calculated for tablets and capsules.

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.

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.

The author describes a separation method for two active ingredients in the contraceptive pill with liquid chromatography UV detection.

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.

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.

An all-electronic validation can provide storage costs savings and ensured document legibility.

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.

The author explains how a sponsor company can select and partner with a CRO for the redevelopment and revalidation of analytical test methods.

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.

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.

This study investigated the effectiveness of the direct extraction of tablets and shaking time on the disintegration of tablets, solubilization, and recovery of ibuprofen from tablets of various formulations, strengths, and spiked placebo.

This article presents the findings of PhRMA's annual workshop, held in September 2000, that convened to draft an acceptable analytical practice that would clarify the essential elements of a complete and compliant transfer.

Because drug delivery at a zero-order rate provides uniform concentration of a drug for absorption, this study attempts to identify a simple mathematical method to quantitatively express the deviation from zero-order kinetics.

Appropriate sampling procedures, proper preparation, and correct instrumental parameters may yield differing, but correct, results.