Nitrosamines Exchange

Topic	Replies	Views	Activity
How-To in the community -Tutorial How-To If you’re keen to get to know how to use the community, here’s a short video and some practical tips which cover: Community features and organization What to do first How to engage or participate in the community How t…	0	1261	August 7, 2021
See Who Else Is A Member How-To One theme which emerged from our discussions yesterday was members here want to see who else is a member. You can visit our public member directory here.	1	443	July 2, 2021
Introduce yourself here! About Nitrosamines Exchange Hello and welcome to the Nitrosamines Exchange Community. Whether you’re new to the topic or you’ve been a here a while, we’re really happy to have you here and helping us build knowledge and best practices to carry out…	239	2956	April 2, 2023
FDA/HESI Collaborative Roadmap: Advancing Hazard and Risk Assessment of Nitrosamine Impurities in Pharmaceuticals Limits of Nitrosamines NDSRI , ames , FDA , Drug_Substance_APIs	2	45	June 5, 2023
FDA/HESI Research Roadmap Planning on Hazard and Risk Assessment of Nitrosamine Impurities in Drugs Events / Workshops / Webinars featured	17	898	June 5, 2023
Current Nitrosamine Landscape in Japan? New Scientific Knowledge & Development	54	1821	June 5, 2023
Establishing acceptable intakes (AI) for complex nitrosamines (NDSRIs) Limits of Nitrosamines NDSRI	16	556	June 4, 2023
Fda行业指南中总亚硝胺杂质含量要求 Limits of Nitrosamines Drug_Substance_APIs	1	98	June 2, 2023
A Nitrite Excipient Database: A Useful Tool to Support N-Nitrosamine Risk Assessments for Drug Products Root Causes Excipients	0	50	June 2, 2023
FDA solicit comments on assessment of NDSRIs Guidance, Documents, Resources featured	10	823	June 2, 2023
Principles and procedures for implementation of ICH M7 recommended (Q)SAR analyses Limits of Nitrosamines	2	160	June 1, 2023
Risk Analysis of Colorants and Flavorings in Pharmaceutical Formulations Guidance, Documents, Resources Excipients	6	130	June 1, 2023
Secondary amine Risk Assessment Guidance, Documents, Resources	9	335	June 1, 2023
pH modification N-nitrosamines Chemistry	1	131	May 31, 2023
Limits for N-nitroso vortioxetine Limits of Nitrosamines	2	156	May 31, 2023
N-nitroso Des-methyl Dapoxetine Limits of Nitrosamines FDA , Manufacturing , Drug_Substance_APIs	12	273	May 31, 2023
MEGLUMINE (Methylglucamine) Limits of Nitrosamines Manufacturing , Drug_Substance_APIs , Excipients	9	252	May 31, 2023
Approaches and Considerations for the Investigation and Synthesis of N-Nitrosamine Drug Substance-Related Impurities (NDSRIs) New Scientific Knowledge & Development NDSRI	1	189	May 31, 2023
👨‍💻 Nitrosamines Analysis in Solvents by GC-MS/MS Analytical Methods Hub Analytical-Hub , AH-Solvents	5	1386	May 28, 2023
✌️Need✌️ your input on NDSRIs challenges? Limits of Nitrosamines	33	1157	May 26, 2023
Nitrosamine in Peptides Guidance, Documents, Resources Drug_Substance_APIs	2	171	May 26, 2023
FDA Revisiting the mutagenicity and genotoxicity of N-nitroso propranolol in bacterial and human in vitro assays Limits of Nitrosamines FDA , NDSRI , ames , NDSRIs , featured	1	483	May 24, 2023
The acceptance Intake of Nitroso-Propranolol Limits of Nitrosamines Drug_Substance_APIs	16	1418	May 24, 2023
Mutagenic impurities in pharmaceuticals: A critical assessment of the cohort of concern with a focus on N-nitrosamines Limits of Nitrosamines NDSRI	2	428	May 23, 2023
Setting limit for Nitrite and Nitrate in water used for Active Ingredients synthesis Solvent/Water Manufacturing , Drug_Substance_APIs	2	193	May 23, 2023
Nitroso Furosemide Limits of Nitrosamines NDSRI	1	168	May 20, 2023
Guidelines for Antibiotic group drug substances for the limit of Nitrosamine impurities . (Eg. Azithromycin, Erythromycin ) About Nitrosamines Exchange	2	237	May 18, 2023
Nitrosamines and bioequivalence studies Risk Assessment Strategy / Tools & Technology	3	326	May 16, 2023
Indigo carmine as secondary amine? Excipients	7	197	May 16, 2023
Imidazole is a secondary amine? Storage (Stability)	9	376	May 16, 2023

How-To in the community -Tutorial

If you’re keen to get to know how to use the community, here’s a short video and some practical tips which cover: Community features and organization What to do first How to engage or participate in the community How t…

0

1261

August 7, 2021

See Who Else Is A Member

How-To

One theme which emerged from our discussions yesterday was members here want to see who else is a member. You can visit our public member directory here.

1

443

July 2, 2021

Introduce yourself here!

About Nitrosamines Exchange

Hello and welcome to the Nitrosamines Exchange Community. Whether you’re new to the topic or you’ve been a here a while, we’re really happy to have you here and helping us build knowledge and best practices to carry out…