Development and validation of HPLC methods for the determination of potential extractables from elastomeric stoppers in the presence of a complex surfactant vehicle used in the preparation of parenteral drug products

Journal of Pharmaceutical and Biomedical Analysis

Volumn 43, Issue 2, 2007, Pages 558-565

  Xiao, Baiming ^a   Gozo, Stephen K ^a   Herz, Lori ^a  

^a BRISTOL MYERS SQUIBB   (United States)

Author keywords

2,6 Di tert butyl para cresol (BHT); Container closures; Cremophor; Elastomeric stopper; HPLC; Method development; Method validation; Octylated diphenylamine antioxidant; Parenteral drug product; Pentylphenol; Polyoxyethylated Castor oil; Potential extractables; Rubber stopper; Sulfur; Surfactant; Tetrakis(methylene(3,5 di tert butyl 4 hydroxyhydro cinnamate)) (Organox 1010); Ultraviolet detection; Zinc dithiocarbamate

Indexed keywords

ANTIOXIDANT; BUTYLCRESOL; CINNAMIC ACID DERIVATIVE; DIPHENYLAMINE DERIVATIVE; DITHIOCARBAMIC ACID DERIVATIVE; ELASTOMER; METHANE; PENTYLPHENOL; PHENOL DERIVATIVE; SOLUBILIZER; SULFUR; SURFACTANT; TETRAKIS[METHYLENE (3,5 DI TERT BUTYL 4 HYDROXYHYDROCINNAMATE)]METHANE; ZINC DITHIOCARBAMATE;

ACCURACY; ARTICLE; CONTAINER; DEVICE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; PRIORITY JOURNAL; QUANTITATIVE ASSAY; SEPARATION TECHNIQUE; STOPPER; VALIDATION PROCESS; VISCOSITY;

BUTYLATED HYDROXYTOLUENE; CHEMISTRY, PHARMACEUTICAL; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; CINNAMATES; DIPHENYLAMINE; DOSAGE FORMS; DRUG CONTAMINATION; DRUG PACKAGING; ELASTOMERS; ETHANOL; LINEAR MODELS; PHARMACEUTICAL SOLUTIONS; PHENOLS; POLYETHYLENE GLYCOLS; REPRODUCIBILITY OF RESULTS; SENSITIVITY AND SPECIFICITY; SPECTROPHOTOMETRY, ULTRAVIOLET; SULFUR COMPOUNDS; SURFACE-ACTIVE AGENTS; THIOCARBAMATES; VEHICLES; ZINC COMPOUNDS;

EID: 33845653717     PISSN: 07317085     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jpba.2006.08.020     Document Type: Article

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