This ebook provides a comprehensive overview of nitrosamine analysis for the pharmaceutical industry.


In recent years, nitrosamines have been detected in various medicines, leading to voluntary product recalls from the market. Nitrosamines analysis is, thus, key to ensuring safety and quality in the pharmaceutical industry.
Global regulatory bodies now require pharmaceutical manufacturers to control and strive to mitigate the presence of N-nitrosamines in their products. This is achieved through a combination of risk assessment and analytical testing.
Download this ebook to explore:
- the formation of nitrosamines
- the role of analytical testing in controlling nitrosamines
- method development for nitrosamine analysis
- how impurity analysis with LC–MS/MS can help meet stringent pharmaceutical industry regulatory requirements.
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Ebook: Waters: Nitrosamines analysis with LC/MS-MS
Topics
- AI, analytics and decision support
- Analytical and bioanalysis
- Chromatography and separations
- Continuous manufacturing and PAT
- Data integrity
- Drug Development
- Excipients and raw materials
- Formulation and drug delivery
- Impurities, contaminants and nitrosamines
- Liquid Chromatography - Mass Spectrometry (LC-MS)
- Mass spectrometry and omics
- metformin
- Quality, microbiology and contamination control
- Raw materials and supply chain (bioprocess)
- Regulation and compliance
- Waters


