Root Causes

Drug Substance (APIs) Storage (Stability) 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	374	April 14, 2021
Nitrites in xanthan gum? Excipients	0	134	April 22, 2024
Low nitrite excipients Excipients Excipients	9	1094	April 12, 2024
Theoretical estimation of the conversion of a tertiary amine to nitrosamine Root Causes	8	724	April 6, 2024
MCC with nitrite levels of 0.1 ppm or less Excipients Excipients	4	705	March 4, 2024
Mechanochemistry: Solid phase nitrosation for reference standards synthesis and impurity investigations? Root Causes	1	218	February 21, 2024
The effect of nitrite and nitrate presence in raw materials on nitrosamine risk Excipients	15	2081	February 6, 2024
Nitrosamines from polybags to finished product Packaging	4	438	January 31, 2024
Imidazole is a secondary amine? Storage (Stability)	16	1617	January 30, 2024
Nitrosamines precursors Root Causes	7	785	November 30, 2023
Reformualtion bridging studies Root Causes	3	438	November 16, 2023
Nitrosamnes in PMs & Excipients Questions Excipients Excipients	4	629	November 6, 2023
Low nitrile crosscarmellose sodium Excipients Excipients	0	278	November 6, 2023
Nitrite content in hydroxypropyl methylcellulose Excipients	5	420	November 2, 2023
What factors impact the formation of 1-cyclopentyl-4-nitrosopiperazine (CPNP) by rifapentine Root Causes	0	231	October 31, 2023
Variation requirements Root Causes Drug_Substance_APIs , NDSRI , Storage_Stability , Excipients	2	366	October 2, 2023
Apixaban Drug Substance-Related Impurities (NDSRIs) Root Causes Manufacturing , NDSRI , Excipients , Drug_Substance_APIs	3	953	September 15, 2023
Considerations for high-risk unit operations Manufacturing Processes	2	408	August 18, 2023
Nitrosamines from tertiary amines in azabicycles Root Causes	4	329	June 9, 2023
IPEC Nitrosamine Questionnaire Q&A Excipients Excipients Excipients	6	918	June 8, 2023
A Nitrite Excipient Database: A Useful Tool to Support N-Nitrosamine Risk Assessments for Drug Products Root Causes Excipients	1	650	June 5, 2023
Setting limit for Nitrite and Nitrate in water used for Active Ingredients synthesis Solvent/Water Manufacturing , Drug_Substance_APIs	2	921	May 23, 2023
Indigo carmine as secondary amine? Excipients	7	554	May 16, 2023
The true role of NitrXtes in NDSRIs? Excipients	2	378	April 3, 2023
A Survey of Industrial N-nitrosamine Discharges in Switzerland -Pub Root Causes	0	274	March 1, 2023
Prediction of Nitrosamine formation from Excipients Excipients Storage_Stability , Excipients , Drug_Substance_APIs	19	1277	February 8, 2023
Nitrosamine risks that may arise from the filters Manufacturing Processes Manufacturing	2	633	January 4, 2023
Calcium Phosphate- Opadry-Lhasa Excipients	0	321	December 21, 2022
E&L challenges and pitfalls in connection with NAs & NDRSIs Root Causes	0	323	December 12, 2022
Drug-Nitrite interaction products -Publication review Root Causes Excipients	2	603	November 30, 2022