Application note: Nitrosamines in drug product by HRAM-LCMS
HPLC with HRAM MS method for the determination and quantitation of nitrosamine impurities in drug products consistent with FDA requirements.
This application note details a simple, fast method using HRAM LCMS consistent with current FDA recommendations, for the quantitative analysis of common nitrosamines in drug product formulations and drug substances.
- 11 nitrosamines
- Confidence in HRAM confirmation of impurities
- Quantitation of nitrosamines in drug substance and product samples in line regulatory guidelines
- Acquisition to reporting in GMP compliance-ready software with data integrity and 21CFR11 toolset
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Analytical techniques, Biopharmaceuticals, Chromatography, Data integrity, Excipients, Formulation, Good Manufacturing Practice (GMP), Manufacturing, Mass Spectrometry, Outsourcing, QA/QC, Regulation & Legislation, Research & Development (R&D)