Linked Life Data

16200561

Source:http://linkedlifedata.com/resource/pubmed/id/16200561

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
11
pubmed:dateCreated
2005-10-6
pubmed:abstractText
Standard materials of impurities are needed in pharmaceutical development such as for validating impurity analytical methods. Most often the impurities possess structures, which are difficult and very time consuming to synthesize. In the present work, we demonstrate that a library of degradation products of ragaglitazar--a novel tricyclic-gamma-alkyloxyphenylpropionic acid with hypolipidemic and antidiabetic activity--observed in stability indicating samples of a solid dosage formulation by LC-MS can be produced in a one pot oxidation reaction. The library entities were isolated in small quantities (microg-mg) by preparative HPLC and structurally characterized by NMR spectroscopy and mass spectrometry. The concentrations of the library entities were determined in solution by NMR using an internal standard method. The library was successfully used in the validation work of a newly developed purity method for the drug product providing useful response factors and relative retention times (RRTs) of the degradation products.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Nov
pubmed:issn
0022-3549
pubmed:author
pubmed:issnType
Print
pubmed:volume
94
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
2549-67
pubmed:dateRevised
2006-11-15
pubmed:meshHeading
pubmed:year
2005
pubmed:articleTitle
High speed development work by preparation of an "in-hand" library of NMR-quantified degradation products.
pubmed:affiliation
CMC Development, Novo Nordisk A/S, Novo Nordisk Park, DK-2760 Måløv, Denmark.
pubmed:publicationType
Journal Article