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 …	25	2242	July 24, 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	3214	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…	287	8223	July 20, 2024
Formation of N-Nitrosamine Drug Substance Related Impurities in Medicines: A Regulatory Perspective on Risk Factors and Mitigation Strategies Risk Assessment Strategy / Tools & Technology NDSRI	8	1072	July 27, 2024
EMA/CHMP Concept paper on the revision of the guideline on the chemistry of active substances Guidance, Documents, Resources	3	415	July 26, 2024
How to overcome the challenges of manual read-across when assessing nitrosamine acceptable intake limits New Scientific Knowledge & Development NDSRI	0	15	July 26, 2024
Risk Evaluation of N-Nitrosamines in Drug-Linker Intermediates Used To Generate Antibody–Drug Conjugates -Pub New Scientific Knowledge & Development	1	49	July 26, 2024
TK6 Cell Line Panel Risk Assessment Strategy / Tools & Technology	4	31	July 26, 2024
Nitrosamine testing on stability samples? Confirmatory Testing & Analytical Challenges	19	1272	July 26, 2024
🛑 N-nitroso Ticagrelor N-nitrosamines Chemistry NDSRI	11	2003	July 26, 2024
Sitagliptin NTTP nitrosamine impurity maximum active intake level 37ng to 246.7 ng/per day Risk Assessment Strategy / Tools & Technology	28	4608	July 26, 2024
Background on Purging Factor Calculation for your Risk Assessment Risk Assessment Strategy / Tools & Technology	0	65	July 25, 2024
Useful publications to sharpen your skills for reviewing DS risk assessment Risk Assessment Strategy / Tools & Technology	0	57	July 25, 2024
Exploration and detection of nitrosamine impurity nitroso-STG-19 in sitagliptin tablets and API as well as nitrites in excipients by LC-MS/MS methods -Pub Confirmatory Testing & Analytical Challenges	0	60	July 25, 2024
Development and Manufacture of Oligonucleotides + Nitrosamines Guidance, Documents, Resources	0	118	July 24, 2024
IPEC Webinar on the role of excipients in determine N-nitrosamine risks Events / Workshops / Webinars Excipients	3	275	July 24, 2024
Methylene Blue NDSRI Guidance, Documents, Resources	5	239	July 24, 2024
Stability of resolution solution Confirmatory Testing & Analytical Challenges	1	128	July 24, 2024
Classification of potentially mutagenic impurities under the ICH M7 guideline -Event Events / Workshops / Webinars ICH-M7	0	144	July 23, 2024
Leveraging ICH M7 Control Options 3 and 4: Discussion and Clarification Using Industrial Case Studies -Pub New Scientific Knowledge & Development ICH-M7	0	188	July 23, 2024
Quantification of Nitrite in Excipients and Chemicals: A Versatile and Highly Sensitive Method Using Headspace Gas Chromatography Coupled to Mass Spectrometry -Pub Confirmatory Testing & Analytical Challenges Nitrite , featured	0	193	July 23, 2024
Nitrosamine in vivo mutagenicity workshop Events / Workshops / Webinars EMA	10	538	July 22, 2024
🇪🇺 EMA/409815/2020 Rev.21 (19-Jul-24) Guidance, Documents, Resources EMA	1	526	July 22, 2024
🙋‍♂️ Citizen Petition to FDA on Sitagliptin New Scientific Knowledge & Development	27	3191	July 20, 2024
Pharmaceutical industry wants FDA to extend deadline for testing novel nitrosamines Nitrosamines in the News FDA , NDSRI	5	1056	July 20, 2024
🇯🇵 Current Nitrosamine Landscape in Japan? New Scientific Knowledge & Development	103	9552	July 20, 2024
Call to review USP Risk Assessment Review Toolbox Risk Assessment Strategy / Tools & Technology	110	1939	July 19, 2024
N-Nitroso mirabegron Limits of Nitrosamines	4	2079	August 2, 2023
Nitrosamine impurities in medicines (presented at the ARCS Annual Conference 2024) Events / Workshops / Webinars	12	685	July 17, 2024
Variation for new spec due to updated EMA Guideline Regulatory Intelligence	7	474	July 16, 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 …

25

2242

July 24, 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

3214

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…