Root Causes

Storage (Stability) Drug Substance (APIs) Manufacturing Processes 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	456	April 14, 2021
Lactose, Nitrosamine Risk? Excipients Excipients	36	2951	June 6, 2024
Can Activated carbon promote nitrosamine formation and lead to high Nitrosamine levels in FP? Root Causes	12	673	June 5, 2024
Nitrites in xanthan gum? Excipients	0	343	April 22, 2024
Low nitrite excipients Excipients Excipients	9	1585	April 12, 2024
Theoretical estimation of the conversion of a tertiary amine to nitrosamine Root Causes	8	869	April 6, 2024
MCC with nitrite levels of 0.1 ppm or less Excipients Excipients	4	950	March 4, 2024
Mechanochemistry: Solid phase nitrosation for reference standards synthesis and impurity investigations? Root Causes	1	372	February 21, 2024
The effect of nitrite and nitrate presence in raw materials on nitrosamine risk Excipients	15	2546	February 6, 2024
Nitrosamines from polybags to finished product Packaging	4	692	January 31, 2024
Imidazole is a secondary amine? Storage (Stability)	16	2098	January 30, 2024
Nitrosamines precursors Root Causes	7	1024	November 30, 2023
Reformualtion bridging studies Root Causes	3	555	November 16, 2023
Nitrosamnes in PMs & Excipients Questions Excipients Excipients	4	795	November 6, 2023
Low nitrile crosscarmellose sodium Excipients Excipients	0	379	November 6, 2023
Nitrite content in hydroxypropyl methylcellulose Excipients	5	580	November 2, 2023
What factors impact the formation of 1-cyclopentyl-4-nitrosopiperazine (CPNP) by rifapentine Root Causes	0	284	October 31, 2023
Variation requirements Root Causes Drug_Substance_APIs , NDSRI , Storage_Stability , Excipients	2	428	October 2, 2023
Apixaban Drug Substance-Related Impurities (NDSRIs) Root Causes Manufacturing , NDSRI , Excipients , Drug_Substance_APIs	3	1280	September 15, 2023
Considerations for high-risk unit operations Manufacturing Processes	2	470	August 18, 2023
Nitrosamines from tertiary amines in azabicycles Root Causes	4	377	June 9, 2023
IPEC Nitrosamine Questionnaire Q&A Excipients Excipients Excipients	6	1055	June 8, 2023
A Nitrite Excipient Database: A Useful Tool to Support N-Nitrosamine Risk Assessments for Drug Products Root Causes Excipients	1	841	June 5, 2023
Setting limit for Nitrite and Nitrate in water used for Active Ingredients synthesis Solvent/Water Manufacturing , Drug_Substance_APIs	2	1099	May 23, 2023
Indigo carmine as secondary amine? Excipients	7	629	May 16, 2023
The true role of NitrXtes in NDSRIs? Excipients	2	425	April 3, 2023
A Survey of Industrial N-nitrosamine Discharges in Switzerland -Pub Root Causes	0	314	March 1, 2023
Prediction of Nitrosamine formation from Excipients Excipients Storage_Stability , Excipients , Drug_Substance_APIs	19	1427	February 8, 2023
Nitrosamine risks that may arise from the filters Manufacturing Processes Manufacturing	2	743	January 4, 2023
Calcium Phosphate- Opadry-Lhasa Excipients	0	374	December 21, 2022