Solubility pH, effect

The description provided in this section should include, as applicable, information on the following (a) organoleptic properties (e.g., appearance, odor, taste) (b) solid-state form (i.e., the preferred crystalline polymorph) (c) solubility profile (limit data to aqueous solubility, pH effect, and at most one or two organic solvents (d) pH, pKa, or pKb (e) melting and boiling range (f) specific gravity or bulk density (g) spectroscopical characteristics such as a specific rotation, refractive index, and fluorescence and (h) isomeric composition. [Pg.195]