Description and solubility requirement as per USP/BP/EP :
These tests are only for information but not standards does not need to comply.
These tests are only for information but not standards does not need to comply.
Long time ago, color and other organoleptic characteristics (taste,
odor) and description (including the solubility and clearance of the solution)
pertaining to an article, formerly included in the individual monograph, were
considered subjective and general in nature. Now, this information is provided
in the "Description and Solubility Section" of the USP-NF 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.
This explanation is so stated under the subtitle: “Description and Relative Solubility of USP and NF
Articles” at the beginning of the section titled: “DESCRIPTION AND RELATIVE
SOLUBILITY”.
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