Root Causes

Manufacturing Processes Storage (Stability) Drug Substance (APIs) Solvent/Water Excipients 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	619	April 14, 2021
Presence of nitrosamine impurities in Excipients use for Drug products Excipients	0	100	August 1, 2025
Nitrosamines in Carbamazepine? Drug Substance (APIs) Drug_Substance_APIs	5	869	June 27, 2025
Potential Nitrosamine Formation Risk in Fluid Bed Granulation Using Povidone as Binder Solution Manufacturing Processes	9	533	June 24, 2025
Passivation with nitric acid Root Causes	4	198	June 5, 2025
Nitrosamine from Cleaning Agents? Root Causes	9	1388	May 29, 2025
Testing and controls for nitrosamines for components of container closure systems Packaging Packaging	17	1808	April 25, 2025
Can Ionized Air in Pharma Pose a Risk of Nitrite Formation Excipients Excipients	4	366	March 10, 2025
Nitrosamines precursors Root Causes	9	1824	January 31, 2025
Low nitrite excipients Excipients Excipients	11	2681	November 27, 2024
Nitrosamnes in PMs & Excipients Questions Excipients Excipients	5	1059	November 22, 2024
Managing Nitrite Impurities: A Supplier-Manufacturer Approach to Mitigate Nitrosamine Risk Excipients Excipients	2	624	October 18, 2024
Lactose, Nitrosamine Risk? Excipients Excipients	35	3427	April 6, 2022
Can Activated carbon promote nitrosamine formation and lead to high Nitrosamine levels in FP? Root Causes	12	1148	June 5, 2024
Nitrites in xanthan gum? Excipients	0	456	April 22, 2024
Theoretical estimation of the conversion of a tertiary amine to nitrosamine Root Causes	8	1005	April 6, 2024
MCC with nitrite levels of 0.1 ppm or less Excipients Excipients	4	1339	March 4, 2024
Mechanochemistry: Solid phase nitrosation for reference standards synthesis and impurity investigations? Root Causes	1	463	February 21, 2024
The effect of nitrite and nitrate presence in raw materials on nitrosamine risk Excipients	15	3241	February 6, 2024
Nitrosamines from polybags to finished product Packaging	4	1041	January 31, 2024
Imidazole is a secondary amine? Storage (Stability)	16	3178	January 30, 2024
Reformualtion bridging studies Root Causes	3	641	November 16, 2023
Low nitrile crosscarmellose sodium Excipients Excipients	0	433	November 6, 2023
Nitrite content in hydroxypropyl methylcellulose Excipients	5	970	November 2, 2023
What factors impact the formation of 1-cyclopentyl-4-nitrosopiperazine (CPNP) by rifapentine Root Causes	0	317	October 31, 2023
Variation requirements Root Causes Drug_Substance_APIs , NDSRI , Storage_Stability , Excipients	2	453	October 2, 2023
Apixaban Drug Substance-Related Impurities (NDSRIs) Root Causes Manufacturing , NDSRI , Excipients , Drug_Substance_APIs	3	1562	September 15, 2023
Considerations for high-risk unit operations Manufacturing Processes	2	545	August 18, 2023
Nitrosamines from tertiary amines in azabicycles Root Causes	4	420	June 9, 2023
IPEC Nitrosamine Questionnaire Q&A Excipients Excipients Excipients	6	1191	June 8, 2023