Pharmaceutical Analysis

A short course in the systematic validation of HPLC methods. We go through the various validation steps in detail. We review the key regulatory requirements from the International Committee on Harmonization (ICH), which also apply to the national...

Recently, the evolution of middle to large biomacromolecules such as peptides or proteins is apparent in the market of pharmaceutical drugs in addition to traditional active ingredients based on small molecules. The use of peptides for clinical...

The aim of this study was to develop a rapid, cost-effective, modified USP <467> HS-GC-FID method for residual solvent determination in pharmaceutical products using the Thermo Scientific™ TriPlus™ 500 Headspace Autosampler and nitrogen as carrier...

This application note provides an evaluation of the quantitative performance of the Thermo Scientific™ TriPlus™ 500 Gas Chromatography Headspace Autosampler for determination of genotoxic nitrosamines in Valsartan according to the Chinese...

Phosphorylated compounds such as nucleotides are known to interact with stainless steel components leading to recovery issues in HPLC and LC/MS. Instrument and column inertness ensure successful analysis. Discover more about the bio-inert analysis...

Benefit from a series of educational resources aimed at pharmaceutical scientists, ranging from pharmaceutical impurity method development, to a complete HPLC workflow comprising multiple detectors, to strategies to improve productivity and reduce...

The small diameter of the capillary in capillary electrophoresis makes for very good heat dissipation compared with conventional electrophoresis. As a consequence, much higher voltages can be applied before heat dissipation becomes an issue. 

A short course in the systematic validation of HPLC methods. The validation process is best started with the first injection during method development. We discuss the importance of having an overall plan for the method development / validation /...

The therapeutic potential of biologic modalities has increased, driving an inevitable move toward exploring more complex biotherapeutic molecule classes. As biotherapeutics become more complex, there is still a demand for superior quantification...

Would you like to learn more about the vital role of compendial methods in pharmaceutical analysis and how, by making adjustments to them, laboratory efficiency can be increased and cost decreased? If so, this on-demand webinar will provide the...

The selection of the proper background electrolyte (BGE) is key to a successful CE method. We first look into the choices for BGE based on our analyte properties. Capillary electrophoresis (CE) is based on migration of charged components in an...

A short course in the systematic validation of HPLC methods. We start by taking an overview of the validation process and review some of the key references that will be useful in setting up a validation process. We also discuss the terminology and...

Once a chemical hit is found through a library screening process and verified, the synthetic route is then optimized. This step involves an iterative process of synthesis and reactivity measurements of the new compound(s) to further develop the drug...

Looking for an effective method for monoclonal antibody analysis? SEC-MS could be the answer...

The capillary electrophoresis (CE)techniques have been around since the 1980s, and commercial instruments available since the end of that decade. So why would we start on such a topic now? There are several indications for a growing interest in CE...