Root Causes

Storage (Stability) Drug Substance (APIs) Manufacturing Processes Excipients 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.

Topic	Replies	Views	Activity
About the Root Causes category Root Causes	0	392	April 14, 2021
Can Activated carbon promote nitrosamine formation and lead to high Nitrosamine levels in FP? Root Causes	5	173	May 15, 2024
Nitrites in xanthan gum? Excipients	0	246	April 22, 2024
Low nitrite excipients Excipients Excipients	9	1259	April 12, 2024
Theoretical estimation of the conversion of a tertiary amine to nitrosamine Root Causes	8	776	April 6, 2024
MCC with nitrite levels of 0.1 ppm or less Excipients Excipients	4	769	March 4, 2024
Mechanochemistry: Solid phase nitrosation for reference standards synthesis and impurity investigations? Root Causes	1	263	February 21, 2024
The effect of nitrite and nitrate presence in raw materials on nitrosamine risk Excipients	15	2200	February 6, 2024
Nitrosamines from polybags to finished product Packaging	4	483	January 31, 2024
Imidazole is a secondary amine? Storage (Stability)	16	1736	January 30, 2024
Nitrosamines precursors Root Causes	7	841	November 30, 2023
Reformualtion bridging studies Root Causes	3	465	November 16, 2023
Nitrosamnes in PMs & Excipients Questions Excipients Excipients	4	676	November 6, 2023
Low nitrile crosscarmellose sodium Excipients Excipients	0	305	November 6, 2023
Nitrite content in hydroxypropyl methylcellulose Excipients	5	461	November 2, 2023
What factors impact the formation of 1-cyclopentyl-4-nitrosopiperazine (CPNP) by rifapentine Root Causes	0	244	October 31, 2023
Variation requirements Root Causes Drug_Substance_APIs , NDSRI , Storage_Stability , Excipients	2	385	October 2, 2023
Apixaban Drug Substance-Related Impurities (NDSRIs) Root Causes Manufacturing , NDSRI , Excipients , Drug_Substance_APIs	3	1044	September 15, 2023
Considerations for high-risk unit operations Manufacturing Processes	2	423	August 18, 2023
Nitrosamines from tertiary amines in azabicycles Root Causes	4	345	June 9, 2023
IPEC Nitrosamine Questionnaire Q&A Excipients Excipients Excipients	6	967	June 8, 2023
A Nitrite Excipient Database: A Useful Tool to Support N-Nitrosamine Risk Assessments for Drug Products Root Causes Excipients	1	708	June 5, 2023
Setting limit for Nitrite and Nitrate in water used for Active Ingredients synthesis Solvent/Water Manufacturing , Drug_Substance_APIs	2	980	May 23, 2023
Indigo carmine as secondary amine? Excipients	7	567	May 16, 2023
The true role of NitrXtes in NDSRIs? Excipients	2	388	April 3, 2023
A Survey of Industrial N-nitrosamine Discharges in Switzerland -Pub Root Causes	0	288	March 1, 2023
Prediction of Nitrosamine formation from Excipients Excipients Storage_Stability , Excipients , Drug_Substance_APIs	19	1317	February 8, 2023
Nitrosamine risks that may arise from the filters Manufacturing Processes Manufacturing	2	665	January 4, 2023
Calcium Phosphate- Opadry-Lhasa Excipients	0	334	December 21, 2022
E&L challenges and pitfalls in connection with NAs & NDRSIs Root Causes	0	335	December 12, 2022