Case study: GC-MS for cGMP nitrosamine testing
What pharmaceutical QA/QC laboratories need to know to overcome the challenges of nitrosamine impurities in drugs for cGMP testing.
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What pharmaceutical QA/QC laboratories need to know to overcome the challenges of nitrosamine impurities in drugs for cGMP testing.
A fast and reproducible gradient HILIC method was set up for the impurity analysis of the hydrophilic temozolomide.
Guidance on generating an intelligent, automated workflow for batch-release analysis of an active pharmaceutical ingredient (API).
How ion chromatography can help to modernise and simplify out-dated USP methods for ion analysis.
Learn how to design, plan, execute and analyse catalyst screening experiments in an efficient manner.
Simultaneous detection of amino acids and organic acids by a single method, therefore reducing analysis time and costs.
This on-demand webinar details a qualified automated approach to nitrosamine testing in products, which simultaneously prepares samples for LC-MS and GC-MS.
Learn how method development software helped Janssen Pharmaceuticals reduce method development time by 80 percent with a 25-fold increase in method quality.
An ion chromatography solution, devoted to fast turnaround of raw material testing for amino acids per the EP monographs.
Download this whitepaper to discover the latest developments and research in QA/QC for biologic therapies via exclusive articles, interviews and application notes.
Research shows using the greatest common divisor (GCD) to define batches in continuous biomanufacturing enhances process control and raw material traceability.
This application aims to replace the two separate compendial methods for the impurity analysis of gabapentin with one single HPLC method.
Researchers review how miniaturised process analytical technologies (PAT), microfluidic affinity assays and microchip capillary electrophoresis, enhance bioprocess monitoring and control.
Everything you need to have confidence and compliance in your nitrosamine impurity analysis.
Transition Analysis (TA) is a method traditionally used to evaluate the condition and integrity of a chromatography column. However, this method generally requires conducting complex data post‑processing and calculations which are hard to automate and to run in real time during the manufacturing process. Thus, completing the TA offline leads…