Article: Elemental impurities: certified reference materials for ICH Q3D, USP<232> & <2232> and Ph.Eur. 5.20
Metallic contamination in drug products, referred to as elemental impurities, may arise from several sources.
List view / Grid view
Metallic contamination in drug products, referred to as elemental impurities, may arise from several sources.
Our culture media are the reliable and convenient choice for aseptic process simulation and include Ready-to-use and Dehydrated Culture Media to meet the specific needs in the pharmaceutical industry.
Generic screening to provide fast solutions for chiral method development, whether needed for routine analytical use, trace analysis, LC/MS or preparative LC, has become increasingly important.
In recent years, ultra-high performance liquid chromatography (hereinafter, UHPLC) has been widely adopted in the pharmaceutical field to improve efficiency and productivity in analytical work.
The Parenteral Drug Association (PDA) has recently published Technical Report No. 82 (TR82) on the topic of Low Endotoxin Recovery (LER), providing both consensus to the science and data behind the analytical issue, as well as to analytical and mitigation strategies.
In this issue we explore reasons behind critical key drug shortages in the EU, whether viability methods effectively detect all viable organisms and how companies can future-proof their digital technologies ahead of Brexit. Also included are articles on higher order protein structure, FMD compliance and Raman spectroscopy.
At PQE Group we foster innovation, efficiency and quality services for sustainable regulated compliance solutions.
Overview on how ionBench products can help LC/MS users with dedicated furniture for their instrumentation
Building from the company’s best-selling SCIEX Triple Quad™ for over 10 years, users can now get triple quad sensitivity plus QTRAP® functionality in one system.
A new AI project marks the first time 10 pharmaceutical companies have agreed to share data to aid drug discovery.
This whitepaper demonstrates the High Performance Liquid Chromatography (HPLC) separation and analysis technique and highlights the importance of using water of sufficient purity as an eluent and how the arium® pro VF system can facilitate this.
Thermo Scientific Orbitrap Exploris 480 mass spectrometer designed for high-throughput biopharmaceutical and academic research laboratories.
Researchers succeed in using machine learning to make the mass analysis of proteins faster and almost error-free.
The connected laboratory is now the only way forward, as the three days of the LABVOLUTION show have clearly demonstrated. Decision-makers, product developers and users from the various segments of the laboratory industry gathered in Hannover for a close look at the latest developments and future trends.
As the pioneers of the Limulus amebocyte lysate (LAL) testing methodology, Associates of Cape Cod, Inc. (ACC), specialises in bacterial endotoxin and (1→3)-ß-D-glucan detection, using FDA-licensed chromogenic, turbidimetric and gel-clot reagent technologies.