| Isolation and identification of ester impurities in RG7128, an HCV polymerase inhibitor. | |
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MedLine Citation:
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PMID: 20439144 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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RG7128 is a di-ester prodrug of a cytidine analog for the treatment of hepatitis C virus (HCV) infection. The structures of nine low level impurities (0.05-0.10%) in RG7128 drug substance were elucidated. The majority of the impurities were formed during the synthesis of the prodrug from the parent drug. Structural elucidations of the impurities were achieved either by enrichment of the impurities using preparative chromatography followed by spectroscopic techniques or by confirmation with a reference sample. Heart-cut and recycle chromatographic techniques were applied to purify closely eluting isomers of RG7128. |
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Authors:
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Justin Chow; Yanzhou Liu; Kate Comstock; Michael Brandl; Fangling Lin; Fujun Li; Keshab Sarma; Tom Alfredson |
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Publication Detail:
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Type: Journal Article Date: 2010-04-09 |
Journal Detail:
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Title: Journal of pharmaceutical and biomedical analysis Volume: 53 ISSN: 1873-264X ISO Abbreviation: J Pharm Biomed Anal Publication Date: 2010 Nov |
Date Detail:
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Created Date: 2010-07-20 Completed Date: 2010-09-16 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 8309336 Medline TA: J Pharm Biomed Anal Country: England |
Other Details:
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Languages: eng Pagination: 710-6 Citation Subset: IM |
Copyright Information:
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Copyright (c) 2010 Elsevier B.V. All rights reserved. |
Affiliation:
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Pharmaceutics, Roche Palo Alto LLC, 3431 Hillview Avenue, Palo Alto, CA 94304, United States. justincchow@hotmail.com |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Antiviral Agents
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analysis* Chromatography, High Pressure Liquid Deoxycytidine / analogs & derivatives*, analysis Drug Contamination* Esters / analysis Hepatitis C / drug therapy* Magnetic Resonance Spectroscopy RNA Replicase / antagonists & inhibitors* Spectrometry, Mass, Electrospray Ionization |
| Chemical | |
Reg. No./Substance:
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0/2'-fluoro-2'-methyl-3',5'-diisobutyryldeoxycytidine; 0/Antiviral Agents; 0/Esters; 951-77-9/Deoxycytidine; EC 2.7.7.48/RNA Replicase |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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