Analytics

Articles

The authors discuss the theory of ion mobility spectrometry, its benefit over HPLC analysis in cleaning verification, and the experimental considerations for method validation and validation.

Cleaning Verification: Method Development and Validation Using Ion Mobility Spectrometry

Angie Drakulich was editorial director of Pharmaceutical Technology.

The first project report on FDA's Sentinel website, discusses the evaluation of existing methods for safety signal identification.

FDA Issues First Sentinel Initiative Project Report: Statistical Methods

Development & Validation of an Inductively coupled Mass Spectrometric Method-ABC Labs Whitepaper

To monitor and control processes or products, analytical methodology must be fit for purpose. An approach to apply quality by design principles to the design and evaluation of analytical methods has therefore been developed to meet these needs.   This article features a downloadable template on which to conduct a failure mode effect analysis (FMEA).

The Application of Quality by Design to Analytical Methods

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

Interphex2007, New York, NY (Apr. 26)-Robustness studies for analytical methods are critical in being able to provide the assurance to the quality of an analytical method, a topic addressed in a conference session, "Performing Analytical Method Validation Robustness for Regulatory Compliance," at Interphex on Thursday.

Robustness in Analytical Methods Outlined

Argonne, IL (Nov. 9)-Researchers from Argonne National Laboratory?s Chemistry Division and Xradia have developed a novel X-ray microscopy technique that allows molecular observations of the reactivity of solid surfaces at the nanometer scale, including interfacial reactions such as ion adsorption and catalytic reactions.

New X-ray Microscopy Method Sheds Light on Nanoscale Reactions

AAPS, San Antonio (Oct. 31-The advantages of ultra-performance liquid chromatography over traditional high-performance liquid chromatographic were the center of the presentation, ?Strategies for Rapid Chromatographic Method Development from Preclinical to Phase 3,? by Charanjeet Jassal of Wyeth Pharmaceuticals.

Analysts Present Strategies for Chromatographic Method Development and Validation

AAPS, San Antonio (Oct. 31)-Industry and regulatory agency concerns over process variability have prompted both groups to take a closer look at analytical method transfer processes.

Challenges in Analytical Method Transfer

Outliers may provide useful information about the development and manufacturing process. Analysts use various statistical methods to evaluate outliers and to reduce their impact on the analysis. This article describes some of the more commonly used identification methods.

A Review of Statistical Outlier Methods

As the pace of product development accelerates, the approach to dissolution-method development must advance beyond a manual method and an assay. A natural progression of the method-development process must include the transfer of the manual method onto automated instrumentation.

Analytical Method Development