Control and analysis of hydrazine, hydrazides and hydrazones-Genotoxic impurities in active pharmaceutical ingredients (APIs) and drug products

Journal of Pharmaceutical and Biomedical Analysis

Volumn 54, Issue 5, 2011, Pages 900-910

  Elder, D P ^a   Snodin, D ^b   Teasdale, A ^c  

^a GLAXOSMITHKLINE   (United Kingdom)

^b Xiphora Biopharma Consulting   (United Kingdom)

^c ASTRAZENECA   (United Kingdom)

Author keywords

Chromatography; Derivatisation; Genotoxic; Hydrazine; Spectroscopy

Indexed keywords

1 NICOTINYL 2 LACTOSYLHYDRAZINE; 5 MORPHOLINOMETHYL 3 (5 NITROFURFURYLIDENE AMINO)OXAZOLIDIN 2 ONE; ALLOPURINOL; AZELASTINE; CARBIDOPA; CELECOXIB; COPOVIDONE; DIHYDRALAZINE; EBIFURAMIN; HYDRALAZINE; HYDRAZIDE DERIVATIVE; HYDRAZINE; HYDRAZONE DERIVATIVE; IPRONIAZID; ISONIAZID; ISONICTONIC ACID N' (PYRIDYL 4 CARBONYL)HYDRAZIDE; ISONICTONIC ACID PYRIDINE 4 YLMETHYLENE HYDRAZIDE; METHYLHYDRAZINE; MILDRONATE; NIFUROXAZIDE; NITROFURAL; NITROFUROXAZIDE; POVIDONE; PYRAZINAMIDE; PYRIDOXAL ISONICOTINOYLHYDRAZONE; RIFAMPICIN; RIZATRIPTAN; SQ 84251; UNCLASSIFIED DRUG; UNINDEXED DRUG; VINDESINE SULPHATE;

ANALYTIC METHOD; CAPILLARY ELECTROPHORESIS; DERIVATIZATION; DRUG DEGRADATION; DRUG IMPURITY; DRUG STRUCTURE; GAS CHROMATOGRAPHY; GENOTOXICITY; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HIGH PERFORMANCE THIN LAYER CHROMATOGRAPHY; INTERMETHOD COMPARISON; ION PAIR CHROMATOGRAPHY; MICELLAR ELECTROKINETIC CHROMATOGRAPHY; MICROEMULSION ELECTROKINETIC CHROMATOGRAPHY; PRIORITY JOURNAL; REVIEW; SPECTROPHOTOMETRY; THIN LAYER CHROMATOGRAPHY;

CHEMISTRY TECHNIQUES, ANALYTICAL; DRUG CONTAMINATION; HYDRAZINES; HYDRAZONES; MUTAGENS; PHARMACEUTICAL PREPARATIONS;

EID: 78751705994     PISSN: 07317085     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jpba.2010.11.007     Document Type: Review

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