Tag: Nitrosamines

EDQM New strategy for N-nitrosamine impu

European Pharmacopoeia Commission (EPC) approved the new strategy for N-nitrosamine impurities in individual monographs in

Risk of Nitrosamines, NDSRIs, Nitrosamin

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

Nitrosamines, NDSRIs and Predicting carc

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

EMA Updates Nitrosamines Q&A documen

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

FDA Warning letter to Dupont cites Inade

USFDA Warning letter to Dupont cites inadequate OOS investigations, Root cause and CAPA, Impact  evaluation. The warning letter

Cross Contamination Concerns: FDA Warnin

In September 2022, USFDA issued a Warning letter to Lupin API facility at Tarapur, India

USFDA Warning letter to Mylan on Handlin

USFDA Warning letter to Mylan in 2020 cited inadequacy of cleaning, cleaning procedures, risk assessment of

IPEC issues Questionnaire for Excipient

IPEC Federation announced the availability of the “Questionnaire for Excipient Nitrosamines Risk Evaluation” (version 1,