CHARACTERS

CHARACTERS
The statements under the heading Characters are not to be interpreted in a strict sense and are not requirements.
Solubility
In statements of solubility in the section headed Characters, the terms used have the following significance referred to a temperature between 15 °C and 25 °C.
The term "partly soluble" is used to describe a mixture where only some of the components dissolve. The term "miscible" is used to describe a liquid that is miscible in all proportions with the stated solvent.
IDENTIFICATION
The tests given in the identification section are not designed to give a full confirmation of the chemical structure or composition of the product; they are intended to give confirmation, with an acceptable degree of assurance, that the article conforms to the description on the label.
Certain monographs have subdivisions entitled "First identification" and "Second identification". The test or tests that constitute the "Second identification" may be used instead of the test or tests of the "First identification" provided it can be demonstrated that the substance or preparation is fully traceable to a batch certified to comply with all the requirements of the monograph.
TESTS AND ASSAYS
Scope
The requirements are not framed to take account of all possible impurities. It is not to be presumed, for example, that an impurity that is not detectable by means of the prescribed tests is tolerated if common sense and good pharmaceutical practice require that it be absent. See also below under Impurities.
Calculation
Where the result of a test or assay is required to be calculated with reference to the dried or anhydrous substance or on some other specified basis, the determination of loss on drying, water content or other property is carried out by the method prescribed in the relevant test in the monograph. The words "dried substance" or "anhydrous substance", etc. appear in parenthesis after the result.
Limits
The limits prescribed are based on data obtained in normal analytical practice; they take account of normal analytical errors, of acceptable variations in manufacture and compounding and of deterioration to an extent considered acceptable. No further tolerances are to be applied to the limits prescribed to determine whether the article being examined complies with the requirements of the monograph.
In determining compliance with a numerical limit, the calculated result of a test or assay is first rounded to the number of significant figures stated, unless otherwise prescribed. The last figure is increased by one when the part rejected is equal to or exceeds one half-unit, whereas it is not modified when the part rejected is less than a half-unit.