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Impurity Method for a Drug Product with Two APIs

3 Impurity Method for a Drug Product with Two APIs [Pg.215]

Method development is a challenging and time-consuming process requiring much experience, creativity, logical thinking, and experimentation. With all the software and automated systems available today, method development is still [Pg.217]

Snyder, JJ. Kirkland, and J.L. Glajch, Practical HPLC Method Development, 2nd Edition, Wiley-Interscience, New York, 1997. [Pg.220]

Rasmussen et al., in S. Ahuja and M.W. Dong, eds., Handbook of Pharmaceutical Analysis by HPLC, Elsevier, Amsterdam, 2005, Chapter 6. [Pg.220]

An impurity method for a drug product with two APIs illustrating the use of high-pH mobile phases and the optimization of pH, organic modifier and column... [Pg.210]



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Apies

Drug impurities

Drug products impurities

Drug products method

Production method

With impurities

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