Page 1 |
Save page Remove page | Previous | 1 of 79 | Next |
|
small (250x250 max)
medium (500x500 max)
large ( > 500x500)
Full Resolution
All (PDF)
|
This page
All
Subset |
GENOTOXIC IMPURITY ANALYSIS IN PHARMACEUTICALS
by
Matthew Austin Janson
A Thesis Presented to the
FACULTY OF THE GRADUATE SCHOOL
UNIVERSITY OF SOUTHERN CALIFORNIA
In Partial Fulfillment of the
Requirements for the Degree
MASTER OF SCIENCE
(PHARMACEUTICAL SCIENCE)
December 2009
Copyright 2009 Matthew Austin Janson
Object Description
| Title | Genotoxic impurity analysis in pharmaceuticals |
| Author | Janson, Matthew Austin |
| Author email | matthewjan055@hotmail.com; janson@usc.edu |
| Degree | Master of Science |
| Document type | Thesis |
| Degree program | Pharmaceutical Sciences |
| School | School of Pharmacy |
| Date defended/completed | 2009-09-18 |
| Date submitted | 2009 |
| Restricted until | Unrestricted |
| Date published | 2009-09-23 |
| Advisor (committee chair) | Shen, Wei-Chiang |
| Advisor (committee member) |
Okamoto, Curtis Wang, Clay |
| Abstract | This review paper covers the analytical methods used to monitor genotoxic impurities. Specifically, the impurities discussed here contain hydrazine, nitro, arylamine or aldehyde functional groups as found in pharmaceuticals. These genotoxic impurities can come from many places including starting materials, reagents, intermediates, solvents or unwanted side reactions of the active pharmaceutical ingredient (API) synthetic process that get carried over into the final product. In addition, the API itself can decompose to form genotoxic impurities or they can form in the drug product by reaction between excipients or containers and the API. The control of these potent impurities is critical which are generally monitored at very low levels in the ppm and ppb range. This poses many challenges on the analytical methods to achieve high sensitivity as well as separation of the impurities from the sample matrix for selectivity. |
| Keyword | genotoxic; impurity; pharmaceutical; analysis; review |
| Language | English |
| Part of collection | University of Southern California dissertations and theses |
| Publisher (of the original version) | University of Southern California |
| Place of publication (of the original version) | Los Angeles, California |
| Publisher (of the digital version) | University of Southern California. Libraries |
| Provenance | Electronically uploaded by the author |
| Type | texts |
| Legacy record ID | usctheses-m2610 |
| Rights | Janson, Matthew Austin |
| Repository name | Libraries, University of Southern California |
| Repository address | Los Angeles, California |
| Repository email | http://www.usc.edu/isd/libraries/services/ask_a_librarian/email/ |
| Filename | etd-Janson-3202 |
| Archival file | uscthesesreloadpub_Volume44/etd-Janson-3202.pdf |
Description
| Title | Page 1 |
| Full text | GENOTOXIC IMPURITY ANALYSIS IN PHARMACEUTICALS by Matthew Austin Janson A Thesis Presented to the FACULTY OF THE GRADUATE SCHOOL UNIVERSITY OF SOUTHERN CALIFORNIA In Partial Fulfillment of the Requirements for the Degree MASTER OF SCIENCE (PHARMACEUTICAL SCIENCE) December 2009 Copyright 2009 Matthew Austin Janson |
Comments
Post a Comment for Page 1
