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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.
New research has shown that the global pharmaceutical excipients market is expected to grow from $6,496.05 million in 2018 to $9,847.12 million in 2025.
All drug products have to undergo sterility testing to comply with Good Manufacturing Practices (GMP). Rapid sterility testing, which offers an incubation period of five days or less, provides a solution.
Whitepaper: Establishing the proper alcohol/water proportion for simulating solvents used in controlled extraction studies
This paper provides scientific guidance as well as a case study on the effect of solvent polarity (ethanol/water proportion) on the levels of extractables.
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).
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…
TOC analysis in the lab, at-line, or online enables efficiency gains and process understanding for cleaning validation and monitoring programs.
7 February 2020 | By OSIsoft
Trustworthiness in data is critical for operations within the pharmaceutical and life sciences industries, whether it is for compliance, operational excellence, reporting or development. Hear the latest findings from OSIsoft’s research in our on-demand webinar.
ICH M9 biopharmaceutics classification system-based biowaivers1 is currently at step 2b and feedback from interested parties is being evaluated.2 This guideline should reach the implementation stage (step 4) during 2020. However, industry still has concerns relating to several key areas of the guidance. Here, Dave Elder summarises these ICH M9…
Excipients are integral components of pharmaceutical drug products. Their demand is expected to increase over the next five years owing to their ability to perform various functions such as improving active pharmaceutical ingredient (API) stability, modifying drug release and taste masking. Here, Prateeksha Kaul explores the factors and trends that…