Analytics: Approaches in quality assurance and quality control used in pharmaceutical development and manufacturing - Pharmaceutical Technology

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PharmTech Europe

Analytics
Analytical testing methods in pharma manufacturing. Chromatography, UHPLC, chiral. Near-infrared (NIR) and Raman spectroscopy. Anticounterfeiting. Dissolution testing. Cleaning validation. Extractables & leachables.

Product Spotlight: Analytical Instrumentation

August 2, 2013
Pharmaceutical Technology

Editor's Pick's of Pharmaceutical Science & Technology Innovations: The latest in analytical instrumentation including mass spectrometers, calorimeters, and viscometers.

Demonstrating Biosimilarity

August 2, 2013

Pharmaceutical Technology

Extensive comparability testing is required to ensure that biosimilars have comparable profiles to their reference products.

Using Tandem LC-MS for Cleaning Validation

August 2, 2013

Pharmaceutical Technology

The author describes how liquid chromatography-mass spectrometry works and explains some of its advantages and disadvantages, particularly compared to high-performance liquid chromatography.

Fast Locator 2013-2014 Index

August 1, 2013

View companies' outsourcing profiles from PharmTech's 2013 Outsourcing Resources Fast Locator Index in the following categories.

Analytical and Bioanalytical Testing

July 15, 2013

View case studies of chromatographic, spectroscopic, and imaging methods used in the identification, characterization, and quantification of drug substances products.

Evaluating Risk-Based Specifications for Pharmaceuticals

July 2, 2013

Pharmaceutical Technology

The author discusses the purpose of analysis and testing and the implications for specifications and their underlying statistical distribution.

Microwave Spectroscopy for Enantiomeric Detection of Chiral Molecules

June 2, 2013

Pharmaceutical Technology

Microwave spectroscopy overcomes some of the limitations of circular dichroism and vibrational circular dichroism in analyzing enantiomers.

Methods for Identifying Out-of-Trend Results in Ongoing Stability Data

June 2, 2013

Pharmaceutical Technology

The authors discuss three methods for identification of out-of-trend (OOT) results and further compare the z-score method and the tolerance interval in OOT analysis for stability studies.

Compositing Samples and the Risk to Product Quality

May 2, 2013

Pharmaceutical Technology

Compositing samples is appropriate under certain circumstances but raises caveats on how and when it should be applied.

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