Root Causes

Drug Substance (APIs) Storage (Stability) 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	180	April 14, 2021
Apixaban Drug Substance-Related Impurities (NDSRIs) Root Causes Manufacturing , NDSRI , Excipients , Drug_Substance_APIs	3	317	September 15, 2023
Considerations for high-risk unit operations Manufacturing Processes	2	246	August 18, 2023
Nitrosamines from tertiary amines in azabicycles Root Causes	4	191	June 9, 2023
IPEC Nitrosamine Questionnaire Q&A Excipients Excipients Excipients	6	594	June 8, 2023
A Nitrite Excipient Database: A Useful Tool to Support N-Nitrosamine Risk Assessments for Drug Products Root Causes Excipients	1	341	June 5, 2023
Setting limit for Nitrite and Nitrate in water used for Active Ingredients synthesis Solvent/Water Manufacturing , Drug_Substance_APIs	2	391	May 23, 2023
Indigo carmine as secondary amine? Excipients	7	269	May 16, 2023
Imidazole is a secondary amine? Storage (Stability)	9	657	May 16, 2023
The true role of NitrXtes in NDSRIs? Excipients	2	240	April 3, 2023
A Survey of Industrial N-nitrosamine Discharges in Switzerland -Pub Root Causes	0	165	March 1, 2023
Prediction of Nitrosamine formation from Excipients Excipients Storage_Stability , Excipients , Drug_Substance_APIs	19	927	February 8, 2023
Nitrosamine risks that may arise from the filters Manufacturing Processes Manufacturing	2	323	January 4, 2023
Calcium Phosphate- Opadry-Lhasa Excipients	0	175	December 21, 2022
E&L challenges and pitfalls in connection with NAs & NDRSIs Root Causes	0	198	December 12, 2022
Drug-Nitrite interaction products -Publication review Root Causes Excipients	2	482	November 30, 2022
The effect of nitrite and nitrate presence in raw materials on nitrosamine risk Excipients	7	759	November 9, 2022
Nitrosamine from Cleaning Agents? Root Causes	5	643	October 20, 2022
Nitrocellulose blister material as a source of N-nitrosamine (peer-review-article) Root Causes Packaging	2	558	September 1, 2022
API seem to form N-nitrosamines upon oxidation (e.g. air) and without the presence of nitrosonium ions Root Causes	1	376	August 4, 2022
Exact Root causes for NDMA in Metformin & NDSRI's Impurities in Varenicline, Quinapril & Orphenadrine Root Causes Drug_Substance_APIs	4	473	July 7, 2022
Nitrosamines in Carbamazepine? Drug Substance (APIs) Drug_Substance_APIs	4	281	July 1, 2022
Risk of Nitrosamine Formation from Nitrites in Aqueous Systems Excipients Excipients	0	300	June 27, 2022
A Nitrite Excipient Database - Risk Assessment Root Causes Excipients	6	753	June 15, 2022
Drug substance-related impurities (NDSRIs) in Drug product and Drug substances Root Causes Drug_Substance_APIs	7	1065	June 8, 2022
Anybody dealing with Nitrosopiparazines? Root Causes	1	314	June 7, 2022
FDA Root Causes of Nitrosamines Formation Fellowship Root Causes	0	185	April 14, 2022
Lactose, Nitrosamine Risk? Excipients Excipients	35	1202	April 6, 2022
Risk of Nitrosamine in packaging materials, risk or control? Packaging Packaging	2	508	April 1, 2022
NDMA in German Beer - A success Story Root Causes	1	186	January 25, 2022