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
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)
