Topics tagged NDSRI

Topic	Replies	Views	Activity
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…	18	681	May 15, 2024
🇺🇸 FDA - Fiscal Year 2024 Generic Drug Science and Research Initatives Public Workshop Events / Workshops / Webinars NDSRI	31	1308	May 14, 2024
Managing the complexities of NDSRI method development: The N-nitroso propranolol case story Events / Workshops / Webinars NDSRI	0	71	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	144	May 13, 2024
Using the Carcinogenicity Potency Categorization Algorithm to Predict N-Nitrosamine Carcinogenicity -Webinar Events / Workshops / Webinars CPCA , NDSRI	0	69	May 13, 2024
🇺🇸 FDA - Updated information on recommended AI for NDSRIs (23/Feb/2024) - Tables 2 & 3 Limits of Nitrosamines Limits , FDA , NDSRI	15	1603	May 12, 2024
Pharmaceutical industry wants FDA to extend deadline for testing novel nitrosamines Nitrosamines in the News FDA , NDSRI	4	821	May 11, 2024
APIC NA Risk Assessment Template Guidance, Documents, Resources Drug_Substance_APIs , NDSRI	5	2138	May 11, 2024
Visualization of Categorized Compounds by CPCA Limits of Nitrosamines NDSRI , featured	58	6171	May 3, 2024
Autonomous CPCA Web-based calculator FREE Guidance, Documents, Resources Drug_Substance_APIs , NDSRI	28	3604	May 2, 2024
N-nitroso-rivaroxaban amide Confirmatory Testing & Analytical Challenges Drug_Substance_APIs , NDSRI	5	771	April 27, 2024
Nitrosamine testing results Limits of Nitrosamines NDSRI	10	707	April 18, 2024
🇸🇦 Saudi FDA requesting Nitrosamines Risk Assessments Guidance, Documents, Resources NDSRI	2	1026	April 17, 2024
Clinico-pathological correlations after intake of potentially nitrosamine/ NDSRIs contaminated drugs New Scientific Knowledge & Development NDSRI	1	187	April 14, 2024
Nitrosamines: A new systematic review New Scientific Knowledge & Development Drug_Substance_APIs , NDSRI , featured	11	2405	April 14, 2024
Whether N-Nitroso Dicyclomine possible? N-nitrosamines Chemistry NDSRI	1	248	April 12, 2024
N-Nitroso Edoxaban Desmethyl Impurity CPCA Score Limits of Nitrosamines NDSRI	6	636	April 8, 2024
Request for risk assessment and confirmatory testing for nortriptyline containing products Limits of Nitrosamines NDSRI	4	420	April 3, 2024
🖩 CPCA Calculation Tool (excel-based) -Updated Limits of Nitrosamines NDSRI , Limits , CPCA	82	8019	April 1, 2024
Risk Assessment Study of Nitrosamines for the API Temozolomide Industrial Process -Pub Risk Assessment Strategy / Tools & Technology NDSRI , featured	1	752	February 6, 2024
Antioxidant as a risk mitigation strategy New Scientific Knowledge & Development NDSRI	5	444	March 28, 2024
🇨🇦 Health Canada updated the guidance and Appendix 1(March 15, 2024) Limits of Nitrosamines NDSRI	10	1592	March 27, 2024
Chemistry of N-Nitroso Ivacaftor N-nitrosamines Chemistry NDSRI	5	657	March 25, 2024
AI difference between FDA and EMA, HC and TGA Limits of Nitrosamines Drug_Substance_APIs , NDSRI	0	619	March 22, 2024
IVACAFTOR (N-Nitroso Ivacaftor) Limits of Nitrosamines NDSRI	0	252	March 22, 2024
Application of duplex sequencing to evaluate mutagenicity -Pub Risk Assessment Strategy / Tools & Technology NDSRI	1	226	March 14, 2024
🇪🇺 OMCL Network published NDSRIs Analytical Methods Confirmatory Testing & Analytical Challenges featured , NDSRI	1	772	March 11, 2024
Simple and Practical Method for the Quantitative High-Sensitivity Analysis of N-Nitroso Duloxetine in Duloxetine Drug Products Utilizing LC-MS/MS Confirmatory Testing & Analytical Challenges NDSRI , Test-method	0	334	March 9, 2024
AI limit for N-Nitroso Losartan Limits of Nitrosamines NDSRI	4	325	March 9, 2024
Is it possible to observe N-nitrosamines formation from oximes? Do you have any reference to support the risk assessment for nitrosamine formation from the reaction of these functional groups in the presence of nitrosating agents? Thank you Risk Assessment Strategy / Tools & Technology NDSRI	2	225	February 27, 2024

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

Events / Workshops / Webinars

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…