Due to the strict regulatory requirements, especially in pharmaceutical analysis, analysis
results with an acceptable quality should be reported. Thus, a proper validation of the …

Publisher Summary Analytical method validation is performed by regulated laboratory, and
deals with the testing of significant method characteristics to ensure that under routine use …

This paper is intended to give guidance in setting-up and interpreting a robustness test. The
different steps in a robustness test are discussed and illustrated with examples. The …

This paper is the first part of a summary report of a new commission of the Société Française
des Sciences et Techniques Pharmaceutiques (SFSTP). The main objective of this …

As reported in a previous paper [1], the main objective of the new commission of the Société
Française des Sciences et Techniques Pharmaceutiques (SFSTP) was the harmonisation of …

Application of statistics has broadened far beyond its origin to various areas of research and
one among them is the design of experiments. Design of experiments gathers the maximum …

Monitoring products for quality assurance in real-time during industrial processes has
become of great importance in recent years. Infrared spectroscopic (IRS) techniques …

The prevalidation strategy was applied to evaluate UV–vis spectrophotometric procedure
with Folin–Ciocalteu's reagent for polyphenols determination. Favourable prevalidation …

Green tea (Camellia sinensis) contains quercetin as a bioactive compound. Quercetin has
anti-inflammatory and anticancer effects. The aim of this paper was to develop and validate …

(azidomethyl)-[1, 1'-biphenyl]-2-carbonitrile (GTI-azide-1) and 5-(4'-(azidomethyl)-[1, 1'-
biphenyl]-2-yl)-1H-tetrazole (GTI-azide-2) are potentially genotoxic impurities that can be …