Determination of genotoxic impurity in atazanavir sulphate drug substance by LC–MS
Sign Up to like & getrecommendations! Published in 2017 at "Journal of Pharmaceutical and Biomedical Analysis"
DOI: 10.1016/j.jpba.2016.09.025
Abstract: HighlightsA sensitive LC–MS method for GTI‐A, genotoxic impurity in atazanavir sulphate drug was developed.Method validation was done in respect of QL, DL, linearity and accuracy.Method: can be used in Quality control laboratories of pharmaceutical industry… read more here.
Keywords: atazanavir sulphate; sulphate drug; genotoxic impurity; method ... See more keywords
Automated fluorimetric determination of the genotoxic impurity hydrazine in allopurinol pharmaceuticals using zone fluidics and on-line solid phase extraction.
Sign Up to like & getrecommendations! Published in 2019 at "Journal of pharmaceutical and biomedical analysis"
DOI: 10.1016/j.jpba.2019.112887
Abstract: In the present study we report a fully automated method for the determination of low levels of the genotoxic impurity hydrazine in allopurinol active pharmaceutical ingredient (API) and formulations based on the concept of zone-fluidics.… read more here.
Keywords: line; line solid; zone fluidics; genotoxic impurity ... See more keywords
A Simple and Direct LC-MS Method for Determination of Genotoxic Impurity Hydroxylamine in Pharmaceutical compounds.
Sign Up to like & getrecommendations! Published in 2017 at "Journal of chromatographic science"
DOI: 10.1093/chromsci/bmx019
Abstract: Hydroxylamine is a known genotoxic impurity compound that needs to be controlled down to ppm level in pharmaceutical processes. It is difficult to detect using conventional analytical techniques due to its physio-chemical properties like lack… read more here.
Keywords: hydroxylamine pharmaceutical; pharmaceutical compounds; genotoxic impurity; method ... See more keywords