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	1267	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…	260	4968	November 27, 2023
Control of NDSRIs impurity at Drug Substance (API) specification Limits of Nitrosamines NDSRI	7	257	November 27, 2023
Limit for NDSRI Limits of Nitrosamines	1	81	November 27, 2023
Nitrosamines precursors Root Causes	6	189	November 27, 2023
Modeling the Impact of Excipients Selection on Nitrosamine Formation towards Risk Mitigation New Scientific Knowledge & Development NDSRI , featured	2	671	November 27, 2023
Deadline for reporting changes Guidance, Documents, Resources	0	69	November 26, 2023
N-nitroso-amlodipine ; N-nitroso-felodipine ; synthesis not successfull but still listed by FDA and EMA as NDSRIs Limits of Nitrosamines	10	591	November 24, 2023
Visualization of Categorized Compounds by CPCA Limits of Nitrosamines NDSRI , featured	55	3868	November 24, 2023
🖩 CPCA Calculation Tool (excel-based) -Updated Limits of Nitrosamines NDSRI , featured , Limits , CPCA	72	4465	November 24, 2023
New paper - Use of molar, instead of weight-based, safety limits New Scientific Knowledge & Development	7	997	November 23, 2023
Updated EMA-Acceptable intakes (AIs) established for N-nitrosamines Limits of Nitrosamines	11	417	November 23, 2023
Differences of limit of EMA and FDA regulatory for category 1 Limits of Nitrosamines	0	96	November 23, 2023
N-nitroso ticagrelor N-nitrosamines Chemistry NDSRI	3	258	November 23, 2023
Limit for Nitroso Ciprofloxacin Limits of Nitrosamines	23	1968	November 23, 2023
Autonomous CPCA Web-based calculator FREE Guidance, Documents, Resources Drug_Substance_APIs , NDSRI	26	1488	November 22, 2023
CPCA Calculation System (Python Desktop) Limits of Nitrosamines Limits , NDSRI	1	177	November 22, 2023
EMA Q&A Appendix 1 update posted Sept 28,2023 Guidance, Documents, Resources	13	1051	November 22, 2023
Calculation of Nitrosamines AI not covered by CPCA Limits of Nitrosamines CPCA	2	148	November 22, 2023
Limit for API having two NDSRI Limits of Nitrosamines NDSRI	9	288	November 21, 2023
Nitrosamine in Azathioprine Risk Assessment Strategy / Tools & Technology Drug_Substance_APIs	2	137	November 20, 2023
🇨🇭 Swiss Medic Guidelines Guidance, Documents, Resources NDSRI	7	517	November 20, 2023
Automated Total Nitrosamine Analyser Confirmatory Testing & Analytical Challenges	18	843	November 19, 2023
Nitrosamine Impurity Test Market expected to grow exponentially by 2029 Nitrosamines in the News	0	145	November 19, 2023
New data released into Lhasa Carcinogenicity Database New Scientific Knowledge & Development	1	277	November 17, 2023
A new root cause? NOx New Scientific Knowledge & Development	13	706	November 17, 2023
Use of the TD50 99 % CI for single dose rodent carcinogenicity studies -Pub Limits of Nitrosamines	5	159	November 16, 2023
Free Webinar: Nitrosamines in Drug Products Events / Workshops / Webinars	12	1187	November 16, 2023
Reformualtion bridging studies Root Causes	3	206	November 16, 2023
Nitrosamine Impurities Deadline: Are Your Products Compliant? Events / Workshops / Webinars	0	164	November 16, 2023

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

1267

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…