Application note: Nitrosamines by GC-MS in Valsartan
Determination of nitrosamines including gentoxic NDMA analysed by GC-MS in Valsartan using direct injection and headspace methods, below required LOD.
A comparison of direct injection and headspace GC-MS and GC-MS/MS methods to determine nitrosamines including genotoxic NDMA and NDEA in Valsartan drug products.
Application benefits are:
- Demonstrated to comply to FDA & EMA requirements
- LOD below allowable limits of 0.3ppm
- GC-MS and GC-MS/MS applied to meet changing regulations
- Acquisition to reporting in GMP compliance-ready software with data integrity and 21CFR11 toolset
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Analytical techniques, Biopharmaceuticals, Chromatography, Data integrity, Drug Delivery Systems, Excipients, Formulation, Good Manufacturing Practice (GMP), Manufacturing, Mass Spectrometry, Outsourcing, QA/QC, Regulation & Legislation, Research & Development (R&D)