Topics tagged Storage

Topic	Replies	Views	Activity
FDA Approves Reformulated Ranitidine - Nitrosamine Impurities - NDMA Nitrosamines in the News FDA , NDSRI , ICH-M7 , Drug_Substance_APIs , Storage_Stability	3	661	November 27, 2025
Nitrocellulose-Based Packaging Inks and Nitrosamine Risk Root Causes Storage_Stability , Packaging	0	448	October 28, 2025
DMF in API, specification limit in formulation Limits of Nitrosamines Drug_Substance_APIs , Storage_Stability , risk-assessment	5	948	August 26, 2024
AI Limit for Nitroso Nebivolol Limits of Nitrosamines FDA , Drug_Substance_APIs , Storage_Stability , Manufacturing , Live-Conversations	11	3030	April 3, 2024
Entidades regulatorias y su postura en el análisis de nitrosaminas en estudios de estabilidad de preparados farmacéuticos Regulatory Intelligence Storage_Stability	0	257	February 28, 2024
Patient In-Use Stability Testing of FDA-Approved Metformin Combination Products for N-Nitrosamine Impurity N-nitrosamines Chemistry Storage_Stability	6	798	January 31, 2024
Variation requirements Root Causes Drug_Substance_APIs , NDSRI , Storage_Stability , Excipients	2	532	October 2, 2023
Formation of N-nitroso Fluconazole and Related Triazole-Imidazole APIs Guidance, Documents, Resources NDSRI , Drug_Substance_APIs , Storage_Stability	4	1694	June 9, 2023
Prediction of Nitrosamine formation from Excipients Excipients Storage_Stability , Excipients , Drug_Substance_APIs	19	2063	February 8, 2023
Stress condition in COC impurity Nitrosamines in the News Storage_Stability	6	906	May 24, 2022
New webinar & Live Q&A May 24th by Naiffer Romero! Nitrosamine exchange – a USP’s knowledge community for all-things nitrosamine Events / Workshops / Webinars Storage_Stability , Packaging , Excipients , Live-Conversations , Drug_Substance_APIs	0	421	April 22, 2022