Nitrosamines Exchange

Topic	Replies	Views	Activity
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	3347	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…	297	9061	October 28, 2024
📅 Updates on Approaches to Acceptable Intakes of Nitrosamine Drug Substance Related Impurities (NDSRIs) and Bioequivalence Assessment for Reformulated Drug Products(CRCG) Events / Workshops / Webinars NDSRI , FDA , featured	19	1636	November 6, 2024
Requirement after reformulation of existing approved drug product for Europe New Scientific Knowledge & Development EMA , FDA	8	201	November 6, 2024
Analytical procedure development and proposed established conditions: A case study of a mass spectrometry based NDSRI analytical procedure -Pub Confirmatory Testing & Analytical Challenges NDSRI	19	1477	November 6, 2024
Cinacalcet Recall Nitrosamines in the News	3	560	November 4, 2024
Resolution of Historically Discordant Ames Test Negative / Rodent Carcinogenicity Positive N-nitrosamines using a Sensitive, OECD-aligned Design-Pub New Scientific Knowledge & Development	0	117	November 2, 2024
Share about Nitrosamines Exchange during your presentations! About Nitrosamines Exchange	8	601	September 18, 2024
NDSRI limit for N-nitroso Ciprofloxacin Guidance, Documents, Resources	2	155	November 1, 2024
⁉️ Duloxetine Impurity NDSRI Limits of Nitrosamines NDSRI	7	550	November 1, 2024
Hypothetical Nitrosamine in 1-H Indazole / CPCA Approach Limits of Nitrosamines NDSRI	3	84	October 31, 2024
N-Nitroso clonidine CPCA score Limits of Nitrosamines	2	111	October 31, 2024
Nitrosamine Mitigation Case Study New Scientific Knowledge & Development	6	312	October 31, 2024
📽 Introduction to Using (Q)SAR for the Assessment of Potential Mutagenicity of Drug Impurities Risk Assessment Strategy / Tools & Technology QSAR	0	132	October 30, 2024
📅 Analytical challenges and the effective management of nitrosamines: The evolving landscape of NDSRI analysis Events / Workshops / Webinars NDSRI	3	398	October 30, 2024
N-Nitroso mirabegron Limits of Nitrosamines	6	2317	October 30, 2024
🇺🇸 FDA Control of Nitrosamine Impurities in Human Drugs revision2 Guidance, Documents, Resources FDA , featured	32	1957	October 30, 2024
What is CPCA Score for “N-nitroso of 3-Amino-1,2,4-triazole" Limits of Nitrosamines NDSRI , Drug_Substance_APIs	5	160	October 30, 2024
🇯🇵 Current Nitrosamine Landscape in Japan? New Scientific Knowledge & Development	124	11531	October 29, 2024
N-Nitroso Desmethyl Tramadol New Scientific Knowledge & Development NDSRI	3	239	October 29, 2024
Determining recommended acceptable intake limits for N-nitrosamine impurities in pharmaceuticals: Development and application of the Carcinogenic Potency Categorization Approach (CPCA) -Pub Limits of Nitrosamines NDSRI , CPCA	0	88	October 29, 2024
FDA Statement on Ritonavir and NITMA Guidance, Documents, Resources	1	146	October 29, 2024
Hexamethyldisilazane (HMDS) can form Nitrosamine Impurity? Guidance, Documents, Resources Drug_Substance_APIs , NDSRI	7	483	October 29, 2024
N-Nitrosamine drug substance related impurities (NDSRIs) – A proposal for the addition of subcategories to carcinogenic potency categorization approach categories 1 and 2 for NDSRIs with a molecular weight > 200 Da -Pub Guidance, Documents, Resources NDSRI , Limits , CPCA	0	148	October 28, 2024
Nitroso Betahistine Impurity C Guidance, Documents, Resources	2	103	October 28, 2024
HBTU Coupling Biproducts - Nitrosamines Risk? N-nitrosamines Chemistry	3	157	October 28, 2024
How to decide if one anticancer drug is for advanced cancer? Risk Assessment Strategy / Tools & Technology risk-assessment	4	235	October 28, 2024
N-nitroso-Duloxetine recall back in the news! Events / Workshops / Webinars NDSRI	11	1144	October 27, 2024
Use of L-cysteine as nitrite scavenging Guidance, Documents, Resources	6	202	October 25, 2024
🛑 N-nitroso Ticagrelor N-nitrosamines Chemistry NDSRI	12	2599	October 25, 2024

See Who Else Is A Member

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

3347

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…