美国药典溶解性.docxVIP

DESCRIPTION AND SOLUBILITY Description and Relative Solubility of USP and NF Articles The — description II and — solubility II statements pertaining to an article (formerly included in the individual monograph) are general in nature. The information is provided for those who use, prepare, and dispense drugs, solely to indicate descriptive and solubility properties of an article complying with monograph standards. The properties are not in themselves standards or tests for purity even though they may indirectly assist in the preliminary evaluation of the integrity of an article. Taste and Odor Organoleptic characteristics are indicated in many instances because they may be useful and descriptive properties of substances. However, they are not meant to be applied as tests for identifying materials. The inclusion of odor or taste among other descriptive properties may aid in identifying the causative agent following accidental exposure to or contact with a substance. This information is provided as a warning or to make an individual aware of sensations that may be encountered. The use of odor or taste as a test for identification or content is strongly discouraged. The characteristic odor of a volatile substance becomes apparent immediately on opening a container of it. The odor may be agreeable (e.g., Peppermint Oil), unpleasant (e.g., Sulfur Dioxide), or potentially hazardous on prolonged exposure (e.g., Coal Tar). Moreover, an unexpected odor may be encountered if the characteristics of a substance are not known or if a container is incorrectly labeled. Consequently, containers of such substances should be opened cautiously, preferably in a well-ventilated fume hood. A characteristic taste or sensation produced in the oral cavity likewise is apparent if traces of residue materials on fingers are inadvertently brought into contact with the tongue or adjacent mucosal tissues. Solubility Only where a special, qua ntitative solubility test is give n in the in dividual m