GEN-MKT-18-7897-A
May 8, 2020 | Blogs, Development, Pharma, QA/QC | 0 comments
In my previous blog, I spoke about the FDA recall of angiotensin II receptor blockers like losartan. This recall was due to the presence of genotoxic nitrosamines.
Is a proactive approach the way to mitigate risk?
Recently, the FDA has re-issued the 2018 guidance to industry, “M7(R1) assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk”. Is this going to help? Or should we have a higher focus of qualitative analysis up front?
Companies need to take a look all facets of their supply chain and manufacturing process. They should be able to ensure they can control the active pharmaceutical ingredients (APIs) throughout the process, whether they do it in their own facility or it is outsourced.
How are they going to do this?
Why you need a control strategy
A control strategy is a planned set of controls derived from current product and process understanding that assures process performance and product quality (ICH Q10, Ref. 8).
A control strategy can include, but is not limited to, the following:
How to ensuring better data, by seeing it all
Work previously presented by Prof. Sörgel, at the Institute for Biomedical and Pharmaceutical Research, Nuremberg, Germany on the benefits of this workflow is that with SWATH® Acquisition you are creating a digital record of all the analytes in the sample.
This approach shows:
Watch out for our next blog where we examine some of the analytical challenges of these molecules.You can learn more about how LC-MS/MS solutions can identify, quantify and monitor the required levels of nitrosamine impurities by accessing technical notes and a webinar addressing the characterization and quantification of the genotoxic impurities.
Learn More >
This is part two of an ongoing blog series on genotoxic analysis. Read part one: “What have we learned from the nitrosamine crisis?” and part three: “Developing a method for nitrosamine analysis in pharmaceutical products“.
RUO-MKT-18-11383-A
The Echo® MS+ system is a novel platform for Acoustic Ejection Mass Spectrometry (AEMS) and combines the speed of acoustic sampling with the selectivity of mass spectrometry. This platform has been designed for high throughput analysis of small and large molecules. The technology combines Acoustic Droplet Ejection (ADE), an Open Port Interface (OPI) and could be coupled with the SCIEX Triple Quad 6500+ system or the ZenoTOF 7600 system.
The Echo® MS+ system comprises of an open-port interface (OPI) and acoustic droplet ejection (ADE) module which could be coupled with a mass spectrometer. The mass spectrometer could either be a SCIEX Triple Quad 6500+ system or the ZenoTOF 7600 system. This non-liquid chromatography based; high-throughput screening platform enables rapid analysis of compounds at speeds of up to 1 sample/second.
The ability to consistently achieve reproducible results on many complex samples across multiple days is critical to a routine clinical laboratory. Laboratories relying on analytical instrumentation require stability and robustness to perform a variety of screening and confirmatory assays with confidence. Liquid chromatography-tandem mass spectrometry (LC-MS/MS) has become the preferred analytical method in the clinical laboratory to reliably perform clinical testing as it provides best-in-class performance and reliability for the most challenging assays. LC-MS/MS offers the required levels of sensitivity and specificity for the detection and quantitation of molecules from complex biological samples, helping laboratories deliver highly accurate data for a variety of clinically relevant analytes across a wide range of assays.
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