Nitrosamines, NDSRIs and Predicting carc
USFDA: Recommended Acceptable Intake Limits for Nitrosamine Drug Substance[1]Related Impurities (NDSRIs) – Guidance for Industry
Warning letters, 483s, Recalls, Import Alerts, Audit observations
USFDA: Recommended Acceptable Intake Limits for Nitrosamine Drug Substance[1]Related Impurities (NDSRIs) – Guidance for Industry
EMA updates Q&A document on N-Nitrosamines. In the Rev 16 (dated 7 July 2023) limits