Application note: Nitrosamines in drug product by HRAM-LCMS
Posted: 16 June 2020 | Thermo Fisher Scientific | No comments yet
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.
Application benefits:
- 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
Related content from this organisation
- ebook: Spectroscopy and materials characterisation applications for pharmaceutical analysis
- Rapid microbiology testing market set to be worth over $6 billion in 2026
- Raman spectroscopy: a useful tool in the fight against COVID-19
- Recent improvements in deep ultra-violet fluorescence devices for cleaning verification
- QA/QC & Analytical Techniques In-Depth Focus 2020
Related topics
Analytical techniques, Biopharmaceuticals, Chromatography, Data integrity, Excipients, Formulation, Good Manufacturing Practice (GMP), Manufacturing, Mass Spectrometry, Outsourcing, QA/QC, Regulation & Legislation, Research & Development (R&D)
