Linked Life Data

17826364

Source:http://linkedlifedata.com/resource/pubmed/id/17826364

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
1-2
pubmed:dateCreated
2007-10-9
pubmed:abstractText
ABT-578, an active pharmaceutical ingredient (API), is a semi-synthetic tetrazole derivative of the fermented polyene macrolide rapamycin. Reverse phase (RP)-HPLC-UV-MS and normal phase (NP)-HPLC-UV-MS methods employing an LC/MSD trap with electrospray ionization (ESI) have been developed to track and map all significant impurities from the synthetic process. Trace-level tracking of key impurities occurring at various process points was achieved using complimentary methodologies, including a stability indicating reverse phase HPLC method capable of separating at least 25 starting materials and process-related impurities from the API (YMC-Pack Phenyl column, UV-MS, 210 nm) and a targeted reverse phase HPLC method capable of separating very polar compounds from crude reaction mixtures (Phenomenex Synergi Polar RP column, UV, 265 nm). In addition, a normal phase HPLC method condition with post-column modifier infusion is described for the separation of epimeric impurities, and analysis of aqueous-sensitive reactive species (YMC-Pack SIL column, UV-MS, 278 nm). Process control strategies were established with these combinations of analytical technologies for impurities analyses to enable a rich understanding of the ABT-578 process.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Oct
pubmed:issn
1570-0232
pubmed:author
pubmed:issnType
Print
pubmed:day
15
pubmed:volume
858
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
106-17
pubmed:dateRevised
2008-6-5
pubmed:meshHeading
pubmed:year
2007
pubmed:articleTitle
Normal phase and reverse phase HPLC-UV-MS analysis of process impurities for rapamycin analog ABT-578: application to active pharmaceutical ingredient process development.
pubmed:affiliation
D-R45T, Process Analytical Chemistry, Global Pharmaceutical Research and Development, Abbott Laboratories, North Chicago, IL 60064-4000, USA. yong.chen@abbott.com
pubmed:publicationType
Journal Article