Strategy for assessing the leachables impact of a material change in a container/closure system

PDA Journal of Pharmaceutical Science and Technology

Volumn 59, Issue 6, 2005, Pages 360-380

  Jenke, Dennis ^a   Swanson, Steve ^a   Edgcomb, Eric ^a   Couch, Tom ^a   Chacko, Molly ^a   Garber, Mary Jo ^a   Fang, Liqiong ^a  

^a BAXTER HEALTHCARE CORPORATION   (United States)

Author keywords

Change control; Compatibility; Container closure systems; Leachables

Indexed keywords

ARTICLE; CONTAINER; CONTAINER CLOSURE SYSTEM; DRUG MANUFACTURE; DRUG STORAGE; EXTRACTION; FILM; LEACHING; MASS SPECTROMETRY; MATERIAL STATE; METHODOLOGY; TEMPERATURE;

CHROMATOGRAPHY, LIQUID; COMPLEX MIXTURES; DRUG CONTAMINATION; DRUG PACKAGING; DRUG STORAGE; GAMMA RAYS; GAS CHROMATOGRAPHY-MASS SPECTROMETRY; HYDROGEN-ION CONCENTRATION; POLYENES; SOLUBILITY; SOLVENTS; SPECTROPHOTOMETRY, ULTRAVIOLET; STERILIZATION; TRACE ELEMENTS;

EID: 30344479927     PISSN: 10797440     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

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