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Quality by Design (QbD) Based Development of a Stability Indicating HPLC Method for Drug and Impurities

✍ Scribed by Karmarkar, S.; Garber, R.; Genchanok, Y.; George, S.; Yang, X.; Hammond, R.

Book ID
115524022
Publisher
Preston Publications
Year
2011
Tongue
English
Weight
535 KB
Volume
49
Category
Article
ISSN
0021-9665

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## Abstract A novel stability‐indicating high‐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