Discussion forum for Pharma Quality events, Regulatory Actions

Warning letters, 483s, Recalls, Import Alerts, Audit observations

Risk of Nitrosamines, NDSRIs, Nitrosamin

Lupin recalled 3 batches of Desloratadine tablets in Dec 2023 for N-Nitroso Desloratadine impurity exceeding

Qvents
January 14, 2024

Nitrosamines, NDSRIs and Predicting carc

USFDA: Recommended Acceptable Intake Limits for Nitrosamine Drug Substance[1]Related Impurities (NDSRIs) – Guidance for Industry

Qvents
August 9, 2023

EMA Updates Nitrosamines Q&A documen

EMA updates Q&A document on N-Nitrosamines. In the Rev 16 (dated 7 July 2023) limits

Qvents
July 19, 2023