Root Causes

Storage (Stability) Drug Substance (APIs) Manufacturing Processes Solvent/Water 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. Excipients

Topic	Replies	Views	Activity
About the Root Causes category Root Causes	0	564	April 14, 2021
Low nitrite excipients Excipients Excipients	11	2260	November 27, 2024
Nitrosamnes in PMs & Excipients Questions Excipients Excipients	5	954	November 22, 2024
Managing Nitrite Impurities: A Supplier-Manufacturer Approach to Mitigate Nitrosamine Risk Excipients Excipients	2	479	October 18, 2024
Lactose, Nitrosamine Risk? Excipients Excipients	35	3258	April 6, 2022
Can Activated carbon promote nitrosamine formation and lead to high Nitrosamine levels in FP? Root Causes	12	934	June 5, 2024
Nitrites in xanthan gum? Excipients	0	416	April 22, 2024
Theoretical estimation of the conversion of a tertiary amine to nitrosamine Root Causes	8	940	April 6, 2024
MCC with nitrite levels of 0.1 ppm or less Excipients Excipients	4	1165	March 4, 2024
Mechanochemistry: Solid phase nitrosation for reference standards synthesis and impurity investigations? Root Causes	1	433	February 21, 2024
The effect of nitrite and nitrate presence in raw materials on nitrosamine risk Excipients	15	2906	February 6, 2024
Nitrosamines from polybags to finished product Packaging	4	894	January 31, 2024
Imidazole is a secondary amine? Storage (Stability)	16	2567	January 30, 2024
Nitrosamines precursors Root Causes	7	1247	November 30, 2023
Reformualtion bridging studies Root Causes	3	630	November 16, 2023
Low nitrile crosscarmellose sodium Excipients Excipients	0	426	November 6, 2023
Nitrite content in hydroxypropyl methylcellulose Excipients	5	785	November 2, 2023
What factors impact the formation of 1-cyclopentyl-4-nitrosopiperazine (CPNP) by rifapentine Root Causes	0	311	October 31, 2023
Variation requirements Root Causes Drug_Substance_APIs , NDSRI , Storage_Stability , Excipients	2	443	October 2, 2023
Apixaban Drug Substance-Related Impurities (NDSRIs) Root Causes Manufacturing , NDSRI , Excipients , Drug_Substance_APIs	3	1413	September 15, 2023
Considerations for high-risk unit operations Manufacturing Processes	2	526	August 18, 2023
Nitrosamines from tertiary amines in azabicycles Root Causes	4	392	June 9, 2023
IPEC Nitrosamine Questionnaire Q&A Excipients Excipients Excipients	6	1149	June 8, 2023
A Nitrite Excipient Database: A Useful Tool to Support N-Nitrosamine Risk Assessments for Drug Products Root Causes Excipients	1	901	June 5, 2023
Setting limit for Nitrite and Nitrate in water used for Active Ingredients synthesis Solvent/Water Manufacturing , Drug_Substance_APIs	2	1293	May 23, 2023
Indigo carmine as secondary amine? Excipients	7	699	May 16, 2023
The true role of NitrXtes in NDSRIs? Excipients	2	453	April 3, 2023
A Survey of Industrial N-nitrosamine Discharges in Switzerland -Pub Root Causes	0	326	March 1, 2023
Prediction of Nitrosamine formation from Excipients Excipients Storage_Stability , Excipients , Drug_Substance_APIs	19	1532	February 8, 2023
Nitrosamine risks that may arise from the filters Manufacturing Processes Manufacturing	2	787	January 4, 2023