This analytical note highlights a robust and sensitive procedure for the quantitation of the nitrosamine impurity NDMA in Ranitidine Hydrochloride drug substance at trace levels by LC-MS/MS. The procedure was validated according to USP General Chapter <1225> and <736>
- LOQ – of 0.033 ppm for NDMA with respect to a 30 mg/mL sample concentration.
- Validated Range – 0.033 ppm-0.5 ppm with respect to a 30 mg/mL sample concentration.
- Accuracy and Precision ≤20%
This application note was developed to provide an analytical resource for regulators
and industry to monitor nitrosamine impurities in drug products, drug substances or other matrices. It is intended to serve as a resource for informational purposes only and not as an USP-NF compendial documentary standard. This document was developed by USP staff without a public comment period and does not reflect USP or USP’s Expert Body opinions on future revisions to official text of the USP-NF. Parties relying on the information in this document bear independent responsibility for awareness of, and compliance with, any applicable federal, state, or local laws and requirements.