Root Causes

Storage (Stability) Manufacturing Processes Solvent/Water Excipients Drug Substance (APIs) Packaging Nitrosamine in Packaging. What’s the role of packaging materials in the overall Nitrosamine control strategy? Some might argued is low; however, every issued guidance makes reference to it as potential source. In this space we will host those discussions.

Topic	Replies	Views	Activity
About the Root Causes category Root Causes	0	684	April 14, 2021
CrN-coated punches and nitrosamine risk Manufacturing Processes	0	81	July 23, 2026
Nitrite Levels in Reverse Osmosis Water Root Causes risk-assessment	7	385	July 17, 2026
Analytical Challenges in Quantifier Ion Selection Due to Mass Error Variability Root Causes Excipients , Drug_Substance_APIs , NDSRI	7	329	July 2, 2026
NDSRI growth with respect to age Root Causes NDSRI	12	568	June 25, 2026
Nitrosamine formation in differnt dosage forms Manufacturing Processes	10	488	March 24, 2026
Impact of nitrocellulose-free foil on dry powder product performance and stability Packaging Packaging	4	312	January 15, 2026
Nitrocellulose-Based Packaging Inks and Nitrosamine Risk Root Causes Storage_Stability , Packaging	0	406	October 28, 2025
Nitrosamine mitigation through NOx absorption Packaging	11	634	September 4, 2025
Presence of nitrosamine impurities in Excipients use for Drug products Excipients	0	345	August 1, 2025
Nitrosamines in Carbamazepine? Drug Substance (APIs) Drug_Substance_APIs	5	1014	June 27, 2025
Potential Nitrosamine Formation Risk in Fluid Bed Granulation Using Povidone as Binder Solution Manufacturing Processes	9	885	June 24, 2025
Passivation with nitric acid Root Causes	4	320	June 5, 2025
Nitrosamine from Cleaning Agents? Root Causes	9	1649	May 29, 2025
Testing and controls for nitrosamines for components of container closure systems Packaging Packaging	17	2249	April 25, 2025
Can Ionized Air in Pharma Pose a Risk of Nitrite Formation Excipients Excipients	4	516	March 10, 2025
Nitrosamines precursors Root Causes	9	2369	January 31, 2025
Low nitrite excipients Excipients Excipients	11	3265	November 27, 2024
Nitrosamnes in PMs & Excipients Questions Excipients Excipients	5	1147	November 22, 2024
Managing Nitrite Impurities: A Supplier-Manufacturer Approach to Mitigate Nitrosamine Risk Excipients Excipients	2	741	October 18, 2024
Lactose, Nitrosamine Risk? Excipients Excipients	35	3765	April 6, 2022
Can Activated carbon promote nitrosamine formation and lead to high Nitrosamine levels in FP? Root Causes	12	1499	June 5, 2024
Nitrites in xanthan gum? Excipients	0	520	April 22, 2024
Theoretical estimation of the conversion of a tertiary amine to nitrosamine Root Causes	8	1218	April 6, 2024
MCC with nitrite levels of 0.1 ppm or less Excipients Excipients	4	1538	March 4, 2024
Mechanochemistry: Solid phase nitrosation for reference standards synthesis and impurity investigations? Root Causes	1	566	February 21, 2024
The effect of nitrite and nitrate presence in raw materials on nitrosamine risk Excipients	15	3704	February 6, 2024
Nitrosamines from polybags to finished product Packaging	4	1264	January 31, 2024
Imidazole is a secondary amine? Storage (Stability)	16	4002	January 30, 2024
Reformualtion bridging studies Root Causes	3	700	November 16, 2023