D. Stability It is common practice to develop stability-indicating assays for quantifying the active drug uniquely in the presence of its degradation products. ... Guidelines for designing stability studies have been published [13-15]. The assay method must directly detect and quantify impurities and degradants in products.
|Title||:||Chromatographic Analysis of Pharmaceuticals|
|Author||:||John A. Adamovics|
|Publisher||:||Marcel Dekker Inc - 1990|