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Strategies for the investigation and control of process-related impurities in drug substances

โœ Scribed by Mark D. Argentine; Paul K. Owens; Bernard A. Olsen


Book ID
113418094
Publisher
Elsevier Science
Year
2007
Tongue
English
Weight
842 KB
Volume
59
Category
Article
ISSN
0169-409X

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Development and validation of a stabilit
โœ Unnam Seshachalam; Bodepudi Haribabu; Kottapalli B. Chandrasekhar ๐Ÿ“‚ Article ๐Ÿ“… 2007 ๐Ÿ› John Wiley and Sons ๐ŸŒ English โš– 900 KB

## Abstract A novel stabilityโ€indicating highโ€performance liquid chromatographic (HPLC) method was developed and validated for assay and determination of impurities of emtricitabine in drug substance. Emtricitabine was found to be degraded under acidic, alkaline, and oxidative stress conditions and