Analysis of N-Nitrosodimethylamine and N-Nitrosodiethylamine Using the Agilent 7697A Headspace Sampler, 8890/5977 GC/MSD System
Aplikace | 2019 | Agilent TechnologiesInstrumentace
GC/MSD, HeadSpace, GC/SQ
ZaměřeníFarmaceutická analýza
VýrobceAgilent Technologies
Klíčová slovandma, ndea, fda, valsartan, headspace, arbs, amount, stats, milliporesigma, sartan, recall, calibration, fill, vial, nitrosodiethylamine, angiotensin, were, impurity, oven, medicines, mode, nitrosodimethylamine, recovered, gho, highbloodpressure, mediacentre, nondetects, temperature, products, drug, newsreleases, temperatre, split, observatory, average, procedure, default, inlet, found, tetrazole, responses, abbey, fausett, target, recovery, type, equilibration, global, dwell, european
Podobná PDF
Analysis of Five Nitrosamine Impurities in Drug Products and Drug Substances Using Agilent GC/MS/MS Instrumentation
2020|Agilent Technologies|Aplikace
Application NotePharma & BiopharmaAnalysis of Five NitrosamineImpurities in Drug Products and DrugSubstances Using Agilent GC/MS/MSInstrumentationAuthorsSoma Dasgupta,Lalith Hansoge, Vivek Dhyani,Samir Vyas, andMelissa ChurleyAgilent Technologies, Inc.AbstractThis application note highlights a comprehensive solution for the determinationand estimation of five nitrosamine impurities (NDMA, NDEA,...
Klíčová slova
relative, relativeresponses, responsesndba, ndbaneipa, neipandipa, ndipandma, ndmandea, ndeaotr, otrfda, fdastd, stdcounts, countsconcentration, concentrationacquisition, acquisitiondrug, drugimpurities
Analysis of Pharmaceuticals’ Impurity - Regulations and Analysis for Carcinogenic Substances -
2020|Shimadzu|Příručky
ApplicationNoteNo.62Analysis of Pharmaceuticals’ Impurity- Regulations and Analysis for Carcinogenic Substances Dheeraj Handique *a), Nitish Suryawanshi *a), Crystal Yeong *b), Cynthia Lahey *b), Shailendra Rane *a), Deepti Bhandarkar *a),Anant Lohar *a), Gao Jie san *c), Li Qiang *c), Fan Jun *c),...
Klíčová slova
ndma, ndmandea, ndeacarcinogenic, carcinogenicsubstances, substancesmutagenic, mutagenicmms, mmsems, emsimpurity, impuritymode, modeims, imsdrug, drugmutagenicity, mutagenicityolmesartan, olmesartanndba, ndbapharmaceuticals
Nitrosamine Impurities Application Guide - Confidently Detect and Quantify Mutagenic Impurities in APIs and Drug Products
2020|Agilent Technologies|PříručkyPrezentace
Nitrosamine ImpuritiesApplication GuideConfidently Detect and QuantifyMutagenic Impurities in APIs andDrug ProductsSartan-BasedLosartan ValsartanCandesartan TelmisartanMetforminRanitidineNitrosamines are formed by chemical reactions that occur during APImanufacturing whether from starting materials, intermediates, reactants, reuse ofsolvents and by-products; they can form through degradation products generatedduring formulation...
Klíčová slova
back, backndma, ndmaneipa, neipafda, fdandea, ndeandipa, ndipandba, ndbametformin, metforminnitrosamine, nitrosamineintroduction, introductionapi, apibest, bestvalsartan, valsartanquant, quantdichloromethan
Nitrosamines Analysis in Pharmaceuticals - Consumables workflow ordering guide
2021|Agilent Technologies|Příručky
Nitrosamines Analysisin PharmaceuticalsUsing Single Quadrupole GC/MS or Triple Quadrupole GC/MSConsumables workflow ordering guideR1NNR2RO2R1RNN2R1ROR21NNNNOMutagenic impurities in APIs and drug products pose a significant risk to health and safety—even in small quantities—and thus are a major concern for drug makers. Mutagenic impuritiescan...
Klíčová slova
nitrosamine, nitrosaminenitrosamines, nitrosaminesndma, ndmandea, ndeamylist, mylistfavorite, favoriteneipa, neipandipa, ndipadrug, drugppm, ppmitems, itemsinlet, inletclick, clickreplacement, replacementsupplies