Topics tagged Drug_Substance

Topic	Replies	Views	Activity
Nitrosamine in Peptides Guidance, Documents, Resources Drug_Substance_APIs	2	940	May 26, 2023
The acceptance Intake of Nitroso-Propranolol Limits of Nitrosamines Drug_Substance_APIs	16	3761	May 24, 2023
Setting limit for Nitrite and Nitrate in water used for Active Ingredients synthesis Solvent/Water Manufacturing , Drug_Substance_APIs	2	1610	May 23, 2023
Nuevas inspecciones en busca de Nitrosaminas y Genotóxicos en API no evaluados New Scientific Knowledge & Development Drug_Substance_APIs	1	762	May 1, 2023
NDMA formation Due to Active Ingredient Degradation and Nitrite Traces in Drug Product Risk Assessment Strategy / Tools & Technology Drug_Substance_APIs	0	774	March 24, 2023
确定DNSRI的限度需要同时进行Ames和致癌性实验吗？ Limits of Nitrosamines Drug_Substance_APIs	4	593	March 2, 2023
EMA Nitrosamine Q&A Rev14 published Guidance, Documents, Resources Drug_Substance_APIs	6	1347	February 23, 2023
Anybody has working with a Gliclazide nitrosamine? Risk Assessment Strategy / Tools & Technology Drug_Substance_APIs	3	1205	February 14, 2023
Carry over limits for Niitrsoamines New Scientific Knowledge & Development Manufacturing , Drug_Substance_APIs	2	794	February 12, 2023
Prediction of Nitrosamine formation from Excipients Excipients Storage_Stability , Excipients , Drug_Substance_APIs	19	1863	February 8, 2023
Nitroso-Diclofenac mutagenicity Confirmatory Testing & Analytical Challenges Drug_Substance_APIs	13	1930	December 21, 2022
EMA Nitrosamine Q&A Rev13 published Guidance, Documents, Resources Drug_Substance_APIs	9	736	December 15, 2022
2 days seminar on nitrosamine and extractable & leachable Events / Workshops / Webinars Packaging , Drug_Substance_APIs , Manufacturing	0	581	November 21, 2022
Selection of MDD in Finished product Limits of Nitrosamines Drug_Substance_APIs	1	626	October 5, 2022
AI for Nitroso-Duloxetine Limits of Nitrosamines Drug_Substance_APIs	5	1631	September 3, 2022
Exact Root causes for NDMA in Metformin & NDSRI's Impurities in Varenicline, Quinapril & Orphenadrine Root Causes Drug_Substance_APIs	4	1089	July 7, 2022
Api或起始物料中亚硝酸盐限度 Limits of Nitrosamines Drug_Substance_APIs	1	584	June 29, 2022
Drug substance-related impurities (NDSRIs) in Drug product and Drug substances Root Causes Drug_Substance_APIs	7	3342	June 8, 2022
亚硝胺杂质分析方法验证的可接受标准 Confirmatory Testing & Analytical Challenges Drug_Substance_APIs	3	517	June 2, 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	410	April 22, 2022
Nitrosamine webinar Events / Workshops / Webinars Drug_Substance_APIs	1	369	March 30, 2022
Azido Impurity Method LC-MS/MS New Scientific Knowledge & Development Drug_Substance_APIs	0	375	March 25, 2022
Mutagenic Impurities Strategies for Identification and Control - now published Guidance, Documents, Resources Excipients , Packaging , Drug_Substance_APIs , Solvent_Water , Manufacturing	9	513	March 2, 2022
Nitrosamine quantification by GC-MS & LC-MS Confirmatory Testing & Analytical Challenges Drug_Substance_APIs	0	331	February 16, 2022
Most burning challenge for API manufacturers? Drug Substance (APIs) Drug_Substance_APIs	12	928	July 9, 2021