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.

Using Quality by Design to Develop Robust Chromatographic Methods

September 2, 2014

Pharmaceutical Technology

The quality-by-design principles used to control process variability are equally important to measurement systems because process variability includes contributions from measurement system variability. The authors use real-life examples from drug development projects to outline how an understanding of chromatographic measurement system variability might be achieved.

Investigation of Various Impurities in Febuxostat

September 2, 2014

Pharmaceutical Technology

Febuxostat is a novel, non-purine, selective inhibitor of xanthine oxidase for hyperuricemia in patients with gout. It is the first promising substitute for allopurinol in 40 years. Various synthetic routes to febuxostat, as well as polymorphic forms and impurities of the drug, are reported in the literature. The authors have also identified several impurities that result from the synthesis of febuxostat. This article describes the identification and control of all isomeric, carryover, and byproduct impurities of febuxostat and its intermediates.

Taking Action on Elemental Impurities

September 1, 2014

Pharmaceutical Technology

Changing regulations are impacting the identification and monitoring of variable materials in excipients.

Fast Locator 2014-2015 Index

August 18, 2014

View companies' outsourcing profiles from PharmTech's 2014 Outsourcing Resources Fast Locator Index in the following categories.

USP Awards Analytical Research

August 15, 2014

USP awards research in analytical tools, anticounterfeiting, and dry powder inhaler products.

Complying with Revised Weighing Guidelines

August 2, 2014

Pharmaceutical Technology

The latest revisions to the USP General Chapters <41> Balances and <1251> Weighing on an Analytical Balance aim to ensure weighing accuracy and eliminate unnecessary overtesting by simplifying previous descriptions and reflecting current state-of-the-art weighing practices.

Reducing False Out-of-Control Signals

August 2, 2014

Pharmaceutical Technology

Control charts that are properly constructed and maintained prevent false out-of-control signals and provide a useful method for monitoring a process.

Advances in the Pharmaceutical Industry Have Shaped Particle Sizing Technology

August 1, 2014

Pharmaceutical Technology Europe

A diverse range of particle sizing solutions is available, from techniques for the characterization of complex formulations through to online PAT tools for real-time measurement.

Contractors Invest in Capacity and Capabilities

August 1, 2014
Pharmaceutical Technology

Contract research, development, and manufacturing organizations invested in new facilities and technologies in 2014 for analytical testing, as well as small- and large-molecule drug development.

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FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
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View Results
Eric Langerr Outsourcing Outlook Eric LangerTargeting Different Off-Shore Destinations
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAsymmetric Synthesis Continues to Advance
Jill Wechsler Regulatory Watch Jill Wechsler Data Integrity Key to GMP Compliance
Sean Milmo European Regulatory WatchSean MilmoExtending the Scope of Pharmacovigilance Comes at a Price
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