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Determination of nitrosamines including gentoxic NDMA analysed by GC-MS in Valsartan using direct injection and headspace methods, below required LOD.
A simple, sensitive and selective direct method using IC coupled to a single quadrupole MS to analyse organic acids in drug solutions.
Separate your science from the status quo, advanced solutions offering superior retention time stability, flexible integration and minimal maintenance.
HPLC with HRAM MS method for the determination and quantitation of nitrosamine impurities in drug products consistent with FDA requirements.
Charged aerosol detection is a technique capable of measuring any non-volatile and many semi-volatile species in a pharmaceutical applications.
Whitepaper: Establishing the proper PH range for aqueous simulating solvents used in extractables profiling
This whitepaper considers the chemical properties of commonly encountered acidic and basic extractables and uses these properties to address questions about establishing the proper pH (or proper pH range).
How modern chromatography data systems are improving regulatory compliance in pharmaceutical manufacturing
Delivering confident QA and QC in pharmaceutical manufacturing is of critical importance. This article discusses how the latest chromatography data systems are ensuring compliance with modern regulatory requirements.
Native liquid chromatography coupled to mass spectrometric analysis for the assessment of higher order structures of proteins
The accurate measurement of the molecular mass of proteins is an essential component of protein characterisation. In this article, Ioannis Papayannopoulos discusses the applications of native protein chromatography coupled to mass spectrometry to enable the characterisation of tertiary structures and non-covalent interactions.
Application of liquid chromatography in characterisation of lipid nanoparticle-based oligonucleotides
Duplex oligonucleotides (OGN) with lipid nanoparticles (LNPs) as delivery vehicles for different therapeutic indications are of great interest in pharma, exemplified by the recent approval of Onpattro from Alnylam Pharmaceuticals. Liquid chromatography is an essential analytical technique in the characterisation of LNPs containing OGNs. This brief review is intended to…
QA/QC & Analytical Techniques In-Depth Focus 2020 with a special focus on Chromatography & Microbiology
This in-depth focus highlights how liquid chromatography coupled to mass spectrometry (LC-MS) can be used to characterise proteins, what to do to improve regulatory compliance when using chromatography and the risks posed by underestimating bacterial contaminants in cleanrooms.
Liquid chromatography is an analytical technique utilised widely in the pharmaceutical industry. How does it work and what other methods can it be combined with to enhance its uses?
Technetium-99m (99mTc) is a synthetic radioisotope that is used worldwide to produce radiopharmaceuticals that are mainly used for diagnostic purposes in nuclear medicines. The purity of the final radiopharmaceutical (99mTc-R) can be confirmed by applying chromatographic methods. This method is based on different rates of movement of substances in a…
In this in-depth focus are articles on consistent analytical techniques when changing laboratories and using chromatographic techniques to identify impurities in radiopharmaceuticals.