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.

Analytical Method Comparability in Registration and Post-Approval Stages: A Risk-Based Approach

October 2, 2014

Pharmaceutical Technology

A risk-based approach is recommended for analytical method comparability for HPLC assay and impurities methods.

Marrying Big Data with Personalized Medicine

October 2, 2014
Pharmaceutical Technology

Data analytic strategies can help companies capitalize on personalized medicine.

The Role of Normal Data Distribution in Pharmaceutical Development and Manufacturing

October 2, 2014

Pharmaceutical Technology

Review challenges in the use of normality testing situations and recommendations on how to assess data distributions in the pharmaceutical development manufacturing environment

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.

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.

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