Assessment of Nitrosamine Impurities in Lurasidone Hydrochloride Using APCI‐LC–MS/MS in MRM Mode for Regulatory Compliance and Stability Evaluation

The developed APCI-LC-MS/MS method provides accurate and reproducible quantification of NDEA, NDMA, and 1-NP in lurasidone hydrochloride. Its sensitivity and compliance with regulatory standards make it suitable for routine quality control and stability testing of nitrosamine impurities in lurasidone hydrochloride drug substance.