Search Results for "Febuxostat Impurities"
Original Source: Identification, synthesis and quantification of process-related impurities in auraptene.
Impurities in chemically synthesized auraptene, an active pharmaceutical ingredient (API), were detected by a gradient Reverse-Phase High-Performance Liquid Chromatography (RP-HPLC) method. Molecular weights and major product ions of these chemical compounds were determined by Liquid Chromatography/Triple Quadrupole (LC-MS/MS) analysis. Structural assignments were presumed as umbelliferone (Imp-I), (E)-6,7-dihydroxy-3,7-dimethyl-2-octene-umbelliferone (Imp-II), (E)-6,7-epoxy-3,7-dimethyl-2-octene-umbellifer...
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Hypersensitivity warning for febuxostat highlighted
Febuxostat (Adenuric) should be stopped immediately if patients have a serious hypersensitivity reaction to the drug...
New quality standards limiting elemental impurities in medicines announced
As part of its ongoing efforts to help ensure the quality of medicines, the U.S. Pharmacopeial Convention (USP) has announced two new standards related to elemental impurities: General Chapters Eleme...
USP announces two new standards related to elemental impurities
As part of its ongoing efforts to help ensure the quality of medicines, the U.S. Pharmacopeial Convention (USP) has announced two new standards related to elemental impurities: General Chapters Eleme...
Impurities, Impurities, Impurities
8 - 10 June 2011 Conference Harrington Hall Hotel, London
EMA adds Q&A on genotoxic impurities & residual solvents
The EMA has updated its quality documents with sections on genotoxic impurities, residual solvents, and heavy metal catalyst residues.
Industry coalition questions USP comments on elemental impurities harmonisation
The industry group that prompted the USP to delay new elemental impurities standards says even when completed, ICH Q3D will take time to implement.
USP delays new elemental impurities standards after industry appeals
The USP has delayed new elemental impurities standards but is still confident they can be harmonized with ICH Q3D even if May 2014 implementation target is kept.
Lack of harmonization on impurities a concern, says industry group
An industry consortium has asked the USP to delay new elemental impurities chapters on concerns that lack of harmonization with ICH Q3D will create compliance difficulties, shortages and additional c...
Matching PubMed Articles
Study of impurity carryover and impurity profile in Febuxostat drug substance by LC-MS/MS technique.
Febuxostat is used in the treatment of hyperuricemia and gout. Several impurities were detected in Febuxostat drug substance. Impurities were identified with the help of LC-MS/MS and were characterize...
African American patients with gout: Efficacy and safety of febuxostat vs allopurinol.
ABSTRACT: BACKGROUND: African Americans are twice as likely as Caucasians to develop gout, but they are less likely to be treated with urate-lowering therapy (ULT). Furthermore, African Americans typ...
The effects of xanthine oxidase inhibition by febuxostat on the pharmacokinetics of theophylline.
Objective: Febuxostat, a nonpurine selective xanthine oxidase (XO) inhibitor, may affect the metabolism of theophylline as XO hydroxylates 1-methylxanthine to 1-methyluric acid. The objective of this...
A rapid, sensitive and selective ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) method was developed and validated for the determination of febuxostat in dog plasma. Usi...
A rapid and sensitive analytical method based on liquid chromatography coupled to tandem mass spectrometry detection with positive ion electrospray ionization was developed for the determination of fe...
