Case Study HPLC Methods in Early Development

9 CASE STUDY HPLC METHODS IN EARLY DEVELOPMENT [Pg.152]

Though several deficiencies were found for this initial method, it was judged adequate for early formulation development. A gradient method with improved resolution of all impurities was developed later (see Chapter 8, Case Study 1). A decision was made to formulate a suspension dosage form for early clinical studies. [Pg.152]

Liquid-liquid extraction with dichloromethane MTBE [Pg.155]

Ahuja and M.W. Dong, eds., Handbook of Pharmaceutical Analysis by HPLC, Elsevier, Amsterdam, 2005. [Pg.155]

Miller and J.B. Crowther, Analytical Chemistry in a GMP Environment A Practical Guide, Jossey-Bass, New York, 2000. [Pg.155]

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