Nitrosamines Exchange

Topic	Replies	Views	Activity
👨‍💻 Dashboard Containing Published AI Limits Guidance, Documents, Resources NDSRI , AI , featured Are you looking for a central place for published AI limits? I have created a dashboard containing Acceptable Intake Limits from FDA, Health Canada and EMA. I am looking for folks that are interest into contributing to …	3	195	May 18, 2024
Potential Topic for an event concerning obtaining the right level of Nitrosamine Risk Assessment information from your CMOs Events / Workshops / Webinars Live-Conversations , NDSRI , Drug_Substance_APIs , Manufacturing , Excipients Hi My Fearless Nitrosaters, I wanted to ask a question to determine if people in the Exchange would find value in an event if the topic was to cover the following: “Benchmarking on obtaining more robust nitrosamine ass…	19	798	May 16, 2024
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	3061	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…	278	7098	May 6, 2024
⚙️🌎CPCA: the gestation, birth, and development -Pub New Scientific Knowledge & Development NDSRI , featured	2	179	May 19, 2024
Challenges and winning strategies to develop an analytical method for Nitrosamines Confirmatory Testing & Analytical Challenges NDSRI	0	8	May 19, 2024
N-nitrososarcosine limit Limits of Nitrosamines	3	270	May 18, 2024
Hot of the presses - New CPCA paper Limits of Nitrosamines NDSRI	1	60	May 17, 2024
🇪🇺 EDQM - top 10 deficiencies observed in new CEP applications Guidance, Documents, Resources risk-assessment	0	566	March 14, 2024
EMA Q&A Appendix 1 update posted on Feb. 26, 2024 Limits of Nitrosamines	28	2005	May 16, 2024
Nitrosamine and NDSRIs conventional detection methods and other options Confirmatory Testing & Analytical Challenges NDSRI	5	100	May 16, 2024
Guidelines for Antibiotic group drug substances for the limit of Nitrosamine impurities . (Eg. Azithromycin, Erythromycin ) About Nitrosamines Exchange	4	1136	May 15, 2024
Can Activated carbon promote nitrosamine formation and lead to high Nitrosamine levels in FP? Root Causes	5	174	May 15, 2024
Ranitidine back in the news! Nitrosamines in the News ranitidine	2	157	May 15, 2024
🇺🇸 FDA - Fiscal Year 2024 Generic Drug Science and Research Initatives Public Workshop Events / Workshops / Webinars NDSRI	31	1333	May 14, 2024
Nitrosamine in Azathioprine Risk Assessment Strategy / Tools & Technology Drug_Substance_APIs	4	564	May 14, 2024
Managing the complexities of NDSRI method development: The N-nitroso propranolol case story Events / Workshops / Webinars NDSRI	0	122	May 14, 2024
How to justify the absence of NDSRIs in finished product if the custom synthesis of the same NDSRIs is not possible? Confirmatory Testing & Analytical Challenges NDSRI	1	191	May 13, 2024
Using the Carcinogenicity Potency Categorization Algorithm to Predict N-Nitrosamine Carcinogenicity -Webinar Events / Workshops / Webinars CPCA , NDSRI	0	95	May 13, 2024
An Organic Guide to N-Nitrosamines: Structure, Reactivity, and Role as Contaminants Guidance, Documents, Resources	1	406	May 13, 2024
Genotoxicity assessments of N-nitrosoethylisopropylamine (NEIPA) and N-nitrosodiisopropylamine (NDIPA) in the C57BL/6J mouse -Pub New Scientific Knowledge & Development NEIPA , NDIPA	0	98	May 13, 2024
Nitrosamine AI limit calculation if the risk is coming only out of excipients' Limits of Nitrosamines	11	768	May 13, 2024
N-Nitroso Metformin Limits of Nitrosamines	8	968	January 29, 2024
Controversial but Public Report Nitrosamines in the News	4	528	April 6, 2024
🇺🇸 FDA - Updated information on recommended AI for NDSRIs (23/Feb/2024) - Tables 2 & 3 Limits of Nitrosamines Limits , FDA , NDSRI	15	1648	May 12, 2024
Are nitrosamines the connecting link or one of the connecting links between the concepts of phototoxicity and photocarcinogenicity due to the intake of a contaminated medication according to the 2019/ 2023 FDA list? New Scientific Knowledge & Development	41	788	May 11, 2024
🙋‍♂️ Citizen Petition to FDA on Sitagliptin New Scientific Knowledge & Development	19	2356	December 13, 2023
Pharmaceutical industry wants FDA to extend deadline for testing novel nitrosamines Nitrosamines in the News FDA , NDSRI	4	829	May 11, 2024
APIC NA Risk Assessment Template Guidance, Documents, Resources Drug_Substance_APIs , NDSRI	5	2162	May 11, 2024
Nitrosamines Published Limits -reference Limits of Nitrosamines	79	12733	May 10, 2024

👨‍💻 Dashboard Containing Published AI Limits

NDSRI , AI , featured

Are you looking for a central place for published AI limits? I have created a dashboard containing Acceptable Intake Limits from FDA, Health Canada and EMA. I am looking for folks that are interest into contributing to …

3

195

May 18, 2024

Potential Topic for an event concerning obtaining the right level of Nitrosamine Risk Assessment information from your CMOs

Events / Workshops / Webinars

Live-Conversations , NDSRI , Drug_Substance_APIs , Manufacturing , Excipients

Hi My Fearless Nitrosaters, I wanted to ask a question to determine if people in the Exchange would find value in an event if the topic was to cover the following: “Benchmarking on obtaining more robust nitrosamine ass…

19

798

May 16, 2024

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

3061

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…