| Article ID | Journal | Published Year | Pages | File Type |
|---|---|---|---|---|
| 7630461 | Journal of Pharmaceutical and Biomedical Analysis | 2015 | 10 Pages |
Abstract
- We developed and validated a HPLC and a CE method for enantiomeric purity assessment.
- We examined 2 commercial batches of the API and 3 finished drug products.
- We identified a possible reason for racemization during synthesis.
- HPLC and CE results were compared to test results of “specific optical rotation”.
Keywords
EDQMIEPN-methyl-d-aspartateNMDAN-acetyl-l-cysteinePFPOPANACFLDHP-β-CDAPIPVDFPh. Eur.pentafluorophenylo-phthaldialdehydeMECNLIFDOECBQCA(2-Hydroxypropyl)-β-cyclodextrinDMSOinternal standardAcetonitrileCapillary electrophoresisPharmaceutical analysisfluorescence detectionChiral separationDimethyl sulfoxideRacemizationDesign of experimentsEuropean PharmacopeiaLaser induced fluorescenceICHActive Pharmaceutical IngredientIsoelectric pointPolyvinylidene fluorideInternational Conference on Harmonisation
Related Topics
Physical Sciences and Engineering
Chemistry
Analytical Chemistry
Authors
Oliver Wahl, Ulrike Holzgrabe,