LCGC Europe-09-01-2014

Chromatography data systems (CDSs) have had a starring role in many regulatory citations involving falsification and fraud in analytical laboratories regulated by Good Manufacturing Practices (GMP). In this instalment of "Questions of Quality" we will examine the citations and identify the technical and procedural controls required to ensure data integrity within these systems. Although focused primarily on the pharmaceutical industry, the principles described here are applicable to all laboratories working to established quality standards.

How can resolution be determined when peak width cannot be measured?

Many problems encountered executing HPLC methods are a result of decisions made during early method development. This article discusses one critical variable in method development, the choice of stationary phase chemistry.

An efficient method for forensic analysis of amphetamines and synthetic cathinones - the illicit drugs often called "bath salts" - in hair samples.

This article describes ways to apply quality-by-design principles to build in a more scientific and risk-based multifactorial strategy in the development of an ultrahigh-pressure liquid chromatography (UHPLC) method for omeprazole and its related impurities.

Click the title above to open the LCGC Europe September 2014 regular issue, Vol 27, No 9, in an interactive PDF format.