Catalogo Articoli (Spogli Riviste)

OPAC HELP

Titolo:
Demonstrative validation study employing a packed column pressurized fluidchromatography method that provides assay, achiral impurities, chiral impurity, and IR identity testing for a drug substance
Autore:
Ashraf-Khorassani, M; Taylor, LT; Williams, DG; Roston, DA; Catalano, TT;
Indirizzi:
Virginia Tech Coll Arts & Sci, Dept Chem, Blacksburg, VA 24061 USA Virginia Tech Coll Arts & Sci Blacksburg VA USA 24061 sburg, VA 24061 USA GD Searle & Co, Skokie, IL 60077 USA GD Searle & Co Skokie IL USA 60077GD Searle & Co, Skokie, IL 60077 USA
Titolo Testata:
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
fascicolo: 5-6, volume: 26, anno: 2001,
pagine: 725 - 738
SICI:
0731-7085(200112)26:5-6<725:DVSEAP>2.0.ZU;2-A
Fonte:
ISI
Lingua:
ENG
Soggetto:
SFC;
Keywords:
achiral impurities; drug substance; FTIR;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Life Sciences
Citazioni:
8
Recensione:
Indirizzi per estratti:
Indirizzo: Taylor, LT Virginia Tech Coll Arts & Sci, Dept Chem, 107 Davidson Hall, Blacksburg, VA 24061 USA Virginia Tech Coll Arts & Sci 107 Davidson Hall Blacksburg VA USA 24061
Citazione:
M. Ashraf-Khorassani et al., "Demonstrative validation study employing a packed column pressurized fluidchromatography method that provides assay, achiral impurities, chiral impurity, and IR identity testing for a drug substance", J PHARM B, 26(5-6), 2001, pp. 725-738

Abstract

Assay development, assay validation, and documentation are reported here for a single packed column pressurized fluid chromatographic/ultraviolet (UV) method that provides: (1) simultaneous detection and quantification for the chiral drug, the chiral impurity and seven achiral impurities; and (2) aFourier transform infrared (FT-IR) spectrometric identification test result for the Searle drug substance sample, xemilofiban. The separation is achieved in less than 30 min with three columns in tandem and a gradient of CO2-CH3OH. The post-column flow is split between UV (assay) and FT-IR (identification). Precision and accuracy are consistent within figures of merit obtained by liquid chromatographic-ultraviolet assays on analogous drug substances. The reported procedure combines three typical drug substance tests into one test (e.g. chiral impurities, achiral impurities, and infrared identification). (C) 2001 Elsevier Science B.V. All rights reserved.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 04/04/20 alle ore 02:58:39