Elemental Impurity Analysis in Pharmaceuticals and Implementation of ICH Q3D
18 Jul 2016
Elemental impurities have been a hot topic since 2009 when the International Conference of Harmonisation (ICH) commenced work on a new standard to provide a global policy to limit these impurities in drug products and ingredients.
Enhanced Sampling and Calibration Procedures for Analysis of Residual Oxygen in Nitrogen Purged Pharmaceutical Packaging by GC-TCD
21 Jan 2016
In recent times, there has been a large increase in the type and number of products packaged using modified atmosphere packaging (MAP) procedures.
Enhanced Residual Solvents Analysis: A Practical Approach to Sampling, Transport, Storage and Analysis
03 Aug 2015
Residual solvents are organic volatile chemicals used or produced in the manufacture of active pharmaceutical ingredients (API), excipients or drug products, which remain in the material at the end of the manufacturing process.
Amino Acid Analysis by High Performance Liquid Chromatography (HPLC) using Post-Column Derivatisation with Ninhydrin and Dual Wavelength Detection
13 Apr 2015
The European Pharmacopeia is moving away from the thin layer chromatography technique for the determination of ninhydrin-positive substances, to more specific and sensitive methods using liquid chromatography (LC) or amino acid analysers.
Elemental Impurity Analysis in Pharmaceuticals
09 Dec 2014
A method to identify the presence of heavy metals in pharmaceuticals was introduced in the United States Pharmacopeia more than 100 years ago.