Root Causes

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

Topic	Replies	Views	Activity
About the Root Causes category Root Causes	0	102	April 14, 2021
A Nitrite Excipient Database: A Useful Tool to Support N-Nitrosamine Risk Assessments for Drug Products Root Causes Excipients	1	90	June 5, 2023
Setting limit for Nitrite and Nitrate in water used for Active Ingredients synthesis Solvent/Water Manufacturing , Drug_Substance_APIs	2	198	May 23, 2023
Indigo carmine as secondary amine? Excipients	7	197	May 16, 2023
Imidazole is a secondary amine? Storage (Stability)	9	385	May 16, 2023
The true role of NitrXtes in NDSRIs? Excipients	2	177	April 3, 2023
A Survey of Industrial N-nitrosamine Discharges in Switzerland -Pub Root Causes	0	109	March 1, 2023
Prediction of Nitrosamine formation from Excipients Excipients Storage_Stability , Excipients , Drug_Substance_APIs	19	780	February 8, 2023
Nitrosamine risks that may arise from the filters Manufacturing Processes Manufacturing	2	236	January 4, 2023
Calcium Phosphate- Opadry-Lhasa Excipients	0	115	December 21, 2022
E&L challenges and pitfalls in connection with NAs & NDRSIs Root Causes	0	130	December 12, 2022
Drug-Nitrite interaction products -Publication review Root Causes Excipients	2	402	November 30, 2022
The effect of nitrite and nitrate presence in raw materials on nitrosamine risk Excipients	7	484	November 9, 2022
Nitrosamine from Cleaning Agents? Root Causes	5	480	October 20, 2022
Nitrocellulose blister material as a source of N-nitrosamine (peer-review-article) Root Causes Packaging	2	423	September 1, 2022
API seem to form N-nitrosamines upon oxidation (e.g. air) and without the presence of nitrosonium ions Root Causes	1	236	August 4, 2022
Exact Root causes for NDMA in Metformin & NDSRI's Impurities in Varenicline, Quinapril & Orphenadrine Root Causes Drug_Substance_APIs	4	309	July 7, 2022
Nitrosamines in Carbamazepine? Drug Substance (APIs) Drug_Substance_APIs	4	174	July 1, 2022
Risk of Nitrosamine Formation from Nitrites in Aqueous Systems Excipients Excipients	0	201	June 27, 2022
A Nitrite Excipient Database - Risk Assessment Root Causes Excipients	6	484	June 15, 2022
Drug substance-related impurities (NDSRIs) in Drug product and Drug substances Root Causes Drug_Substance_APIs	7	505	June 8, 2022
Anybody dealing with Nitrosopiparazines? Root Causes	1	268	June 7, 2022
FDA Root Causes of Nitrosamines Formation Fellowship Root Causes	0	133	April 14, 2022
Lactose, Nitrosamine Risk? Excipients Excipients	35	845	April 6, 2022
Risk of Nitrosamine in packaging materials, risk or control? Packaging Packaging	2	290	April 1, 2022
NDMA in German Beer - A success Story Root Causes	1	126	January 25, 2022
Testing and controls for nitrosamines for components of container closure systems Packaging Packaging	16	425	November 29, 2021
Excipients, morpholine? Root Causes	4	161	October 18, 2021
Nitrosamines - Elastomers perspective (PDA publication) Packaging Packaging	8	243	October 16, 2021
Results from survey on Nitrosamines in Excipients -Any thoughts? Excipients Excipients	10	274	September 23, 2021