Topics tagged Excipients

Topic	Replies	Views	Activity
Nitrite in Amines N-nitrosamines Chemistry Drug_Substance_APIs , Excipients , NDSRI , featured	14	596	April 15, 2026
Excipient Selection Strategies to Mitigate Nitrosamine Risks Risk Assessment Strategy / Tools & Technology Excipients	0	183	April 8, 2026
Optimized UHPLC–Derivatization Method for Low-Level Nitrite Detection in Pharmaceutical Excipients-Pub Confirmatory Testing & Analytical Challenges Excipients	0	195	March 23, 2026
Impact of post approval quantitative changes in excipient composition on nitrosamine formation: De-risking strategy-Pub New Scientific Knowledge & Development Excipients	0	123	March 23, 2026
MEGLUMINE (Methylglucamine) Limits of Nitrosamines Manufacturing , Drug_Substance_APIs , Excipients	28	3717	March 16, 2026
Nitrites/Nitrosamines: The impacts on analytics, but not only Events / Workshops / Webinars Excipients	0	182	February 17, 2026
Nitrosamine Impurities: The Analytical & Regulatory Roadmap (2024-2025) Confirmatory Testing & Analytical Challenges Excipients , risk-assessment , NDSRI	0	403	January 20, 2026
Nitrosamine Impurities in Excipients Limits of Nitrosamines Excipients	11	533	January 8, 2026
Nitrites in Excipients Limits of Nitrosamines Excipients	7	506	November 28, 2025
IPEC Excipient new questionnaire, October 2025 Guidance, Documents, Resources Excipients	2	254	October 23, 2025
Updated: IPEC Questionnaire for Excipient Nitrosamines Risk Evaluation Guidance, Documents, Resources Excipients	2	638	October 23, 2025
Nitrite testing in Excipients Guidance, Documents, Resources Excipients	2	565	August 17, 2025
Nitrosamines excipient EDTA Confirmatory Testing & Analytical Challenges Excipients	3	407	June 12, 2025
Interferencia de matriz para cuantificación de NDBA New Scientific Knowledge & Development Excipients	0	89	May 5, 2025
Can Ionized Air in Pharma Pose a Risk of Nitrite Formation Excipients Excipients	4	437	March 10, 2025
Impact of Antioxidant Excipients on N-nitrosamine Formation and Bioequivalence in Metformin Formulations - Pub New Scientific Knowledge & Development risk-assessment , Excipients , FDA	3	767	February 11, 2025
Low nitrite excipients Excipients Excipients	11	3075	November 27, 2024
Nitrosamnes in PMs & Excipients Questions Excipients Excipients	5	1127	November 22, 2024
Managing Nitrite Impurities: A Supplier-Manufacturer Approach to Mitigate Nitrosamine Risk Excipients Excipients	2	712	October 18, 2024
Primeros pasos para evaluar nitrosaminas en medicamentos Limits of Nitrosamines Manufacturing , Excipients , Drug_Substance_APIs	5	298	September 23, 2024
Determining Low PPB Levels of Nitrite in Polymeric Excipients Confirmatory Testing & Analytical Challenges Excipients	0	288	September 10, 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	22	1738	September 5, 2024
4-(nitroso(vinyl)amino)butanoic acid from Kollidon? N-nitrosamines Chemistry risk-assessment , Excipients	7	515	August 29, 2024
IPEC Webinar on the role of excipients in determine N-nitrosamine risks Events / Workshops / Webinars Excipients	3	499	July 24, 2024
Parts per billion of nitrite in microcrystalline cellulose -Pub Confirmatory Testing & Analytical Challenges Excipients	3	1177	July 3, 2024
Risk analysis of nitrosamine impurities in liquid products (essences and flavors) Risk Assessment Strategy / Tools & Technology Manufacturing , Excipients	3	774	June 28, 2024
Insights from the Lhasa Limited and IPEC Europe Nitrites collaborative meeting Events / Workshops / Webinars Excipients	1	560	June 16, 2024
Lactose, Nitrosamine Risk? Excipients Excipients	35	3635	April 6, 2022
Update: EFPIA workflows for Quality Risk management Jun 2024 v03 Guidance, Documents, Resources Packaging , Manufacturing , Drug_Substance_APIs , Excipients , NDSRI	2	1338	June 4, 2024
N-nitroso cyclamate Limits of Nitrosamines Excipients	9	760	March 15, 2024