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

Latest Issue
PharmTech

Latest Issue
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.

Alternative Solvents for Extractables and Leachables Evaluation

August 2, 2013

Pharmaceutical Technology

The authors examine alternative solvents for extractables and leachables screening evaluation of process components that provide extraction equivalence and do not interfere chromatographically.

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.

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.

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.

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.

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.

ADVERTISEMENT

LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
29%
Oversee medical treatment of patients in the US.
10%
Provide treatment for patients globally.
6%
All of the above.
42%
No government involvement in patient treatment or drug development.
13%
Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
Click here