Method Validation and Measurement of Biomarkers in Nonclinical and Clinical Samples in Drug Development: A Conference Report
✍ Scribed by Jean W. Lee; Russ S. Weiner; Jeff M. Sailstad; Ronald R. Bowsher; Dean W. Knuth; Peter J. O’Brien; Jean L. Fourcroy; Rakesh Dixit; Lini Pandite; Robert G. Pietrusko; Holly D. Soares; Valerie Quarmby; Ole L. Vesterqvist; David M. Potter; James L. Witliff; Herbert A. Fritche; Timothy O’Leary; Lorah Perlee; Sunil Kadam; John A. Wagner
- Publisher
- Springer US
- Year
- 2005
- Tongue
- English
- Weight
- 142 KB
- Volume
- 22
- Category
- Article
- ISSN
- 0724-8741
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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