Influence of formaldehyde impurity in polysorbate 80 and PEG-300 on the stability of a parenteral formulation of BMS-204352: Identification and control of the degradation product

Pharmaceutical Development and Technology

Volumn 9, Issue 2, 2004, Pages 189-195

  Nassar, Munir N ^a   Nesarikar, Vishwas N ^a   Lozano, Ruben ^a   Parker, William L ^a   Huang, Yande ^a   Palaniswamy, Venkatapuram ^a   Xu, Weiwei ^a   Khaselev, Nona ^a  

^a BRISTOL MYERS SQUIBB   (United States)

Author keywords

Formaldehyde; Formaldehyde adduct; Hydroxymethyl degradant; PEG 300; Polysorbate 80

Indexed keywords

3 (5 CHLORO 2 METHOXYPHENYL) 3 FLUORO 2,3 DIHYDRO 6 TRIFLUOROMETHYL 1H INDOL 2 ONE; EXCIPIENT; FORMALDEHYDE; MACROGOL; PHENYLHYDRAZONE DERIVATIVE; POLYSORBATE 80;

ARTICLE; DRUG DEGRADATION; DRUG IMPURITY; DRUG STABILITY; DRUG STORAGE; DRUG STRUCTURE; LIQUID CHROMATOGRAPHY; MASS SPECTROMETRY; NUCLEAR MAGNETIC RESONANCE SPECTROSCOPY; PRIORITY JOURNAL; STORAGE TEMPERATURE;

CHROMATOGRAPHY, HIGH PRESSURE LIQUID; CHROMATOGRAPHY, LIQUID; DRUG STABILITY; DRUG STORAGE; EXCIPIENTS; FORMALDEHYDE; INDOLES; INJECTIONS, INTRAVENOUS; MAGNETIC RESONANCE SPECTROSCOPY; MASS SPECTROMETRY; POLYETHYLENE GLYCOLS; POLYSORBATES; TEMPERATURE;

EID: 2942703943     PISSN: 10837450     EISSN: None     Source Type: Journal    
DOI: 10.1081/PDT-120030249     Document Type: Article

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