Topics tagged Excipients

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…	19	780	May 16, 2024
Low nitrite excipients Excipients Excipients	9	1258	April 12, 2024
N-nitroso cyclamate Limits of Nitrosamines Excipients	9	410	March 15, 2024
Lack of effect of antioxidants on Biopharmaceutics Classification System (BCS) Class III drug permeability -Pub New Scientific Knowledge & Development Excipients	1	368	March 13, 2024
MEGLUMINE (Methylglucamine) Limits of Nitrosamines Manufacturing , Drug_Substance_APIs , Excipients	15	1835	March 12, 2024
Updated: IPEC Position Paper on Role of Excipients in Determining N-Nitrosamine Risks for Drug Products Guidance, Documents, Resources Excipients	3	687	March 7, 2024
MCC with nitrite levels of 0.1 ppm or less Excipients Excipients	4	769	March 4, 2024
A quick (dumb) question Limits of Nitrosamines FDA , Excipients	10	829	January 22, 2024
Risk analysis of nitrosamine impurities in liquid products (essences and flavors) Risk Assessment Strategy / Tools & Technology Manufacturing , Excipients	2	385	November 14, 2023
Nitrosamnes in PMs & Excipients Questions Excipients Excipients	4	675	November 6, 2023
Low nitrile crosscarmellose sodium Excipients Excipients	0	304	November 6, 2023
Parts per billion of nitrite in microcrystalline cellulose -Pub Confirmatory Testing & Analytical Challenges Excipients	2	685	October 28, 2023
Personal perspective on N-Nitrosamines and recent revision of guidelines Events / Workshops / Webinars NDSRI , Excipients	7	656	October 27, 2023
Variation requirements Root Causes Drug_Substance_APIs , NDSRI , Storage_Stability , Excipients	2	385	October 2, 2023
Apixaban Drug Substance-Related Impurities (NDSRIs) Root Causes Manufacturing , NDSRI , Excipients , Drug_Substance_APIs	3	1041	September 15, 2023
Quantitation of Reactive Nitrosating Agents in Pharmaceutical Excipients for N‑Nitrosamine Risk Assessments Risk Assessment Strategy / Tools & Technology Excipients	4	1026	September 7, 2023
FDA Workshop: Mitigation Strategies for Nitrosamine Drug Substance Related Impurities Events / Workshops / Webinars Excipients , FDA , NDSRI , Drug_Substance_APIs , Manufacturing	11	2809	July 27, 2023
Risk Analysis of Colorants and Flavorings in Pharmaceutical Formulations Guidance, Documents, Resources Excipients	9	629	July 21, 2023
IPEC Nitrosamine Questionnaire Q&A Excipients Excipients Excipients	6	966	June 8, 2023
A Nitrite Excipient Database: A Useful Tool to Support N-Nitrosamine Risk Assessments for Drug Products Root Causes Excipients	1	707	June 5, 2023
Prediction of Nitrosamine formation from Excipients Excipients Storage_Stability , Excipients , Drug_Substance_APIs	19	1316	February 8, 2023
Drug-Nitrite interaction products -Publication review Root Causes Excipients	2	614	November 30, 2022
Nitrite / Nitrosamine levels in Excipients Guidance, Documents, Resources Manufacturing , Excipients	0	440	November 17, 2022
Risk of Nitrosamine Formation from Nitrites in Aqueous Systems Excipients Excipients	0	569	June 27, 2022
A Nitrite Excipient Database - Risk Assessment Root Causes Excipients	6	1405	June 15, 2022
New webinar & Live Q&A May 24th by Naiffer Romero! Nitrosamine exchange – a USP’s knowledge community for all-things nitrosamine Events / Workshops / Webinars Storage_Stability , Packaging , Excipients , Live-Conversations , Drug_Substance_APIs	0	303	April 22, 2022
Lactose, Nitrosamine Risk? Excipients Excipients	35	2344	April 6, 2022
Mutagenic Impurities Strategies for Identification and Control - now published Guidance, Documents, Resources Excipients , Packaging , Drug_Substance_APIs , Solvent_Water , Manufacturing	9	415	March 2, 2022
Results from survey on Nitrosamines in Excipients -Any thoughts? Excipients Excipients	10	622	September 23, 2021
Challenges for API Raw Material & DP regarding Excipient / APIs / Packaging? Excipients Excipients	12	1012	August 17, 2021

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…