Uniformity of Content is a pharmaceutical analysis technique for the quality control of hard shell gelatin capsules, or tablets. It is carried out as follows:
Select 10 capsules or tablets at random. If using capsules empty contents of each capsule carefully in a suitable container. Using a suitable analytical method, assay the individual content of the active ingredient in each capsule or tablet.
The preparation complies if not more than one (all within limits) individual content is outside the limits of 85 to 115% of the average content and none is outside the limits of 75 to 125% of the average content. The preparation fails to comply with the test if more than 3 individual contents are outside the limits of 85 to 115% of the average content or if one or more individual contents are outside the limits of 75% to 125% of the average content. According to INDIAN PHARMACOPOIEA Content of active ingredients. Determine the amount of active ingredient(s) by the method described in the Assay and calculate the amount of active ingredient(s) in each capsule. The result lies within the range for the content of active ingredient(s) stated in the monograph. This range is based on the requirement that 20 capsules, or such other number as may be indicated in the monograph, are used in the Assay. Where 20 capsules cannot be obtained, a smaller number, which must not be less than 5, may be used, but to allow for sampling errors the tolerances are widened in accordance with Table 1. The requirements of Table 1 apply when the stated limits are between 90 and 110 per cent. For limits other than 90 to 110 per cent, proportionately smaller or larger allowances should be made Weigh of Active Subtract Weigh of Active ingredients in each Capsules. The table is given in IP.
Famous quotes containing the words uniformity of, uniformity and/or content:
“The diversity in the faculties of men, from which the rights of property originate, is not less an insuperable obstacle to a uniformity of interests. The protection of these faculties is the first object of government.”
—James Madison (1751–1836)
“The diversity in the faculties of men, from which the rights of property originate, is not less an insuperable obstacle to a uniformity of interests. The protection of these faculties is the first object of government.”
—James Madison (1751–1836)
“Nature is, after all, the only book that offers important content on every page.”
—Johann Wolfgang Von Goethe (1749–1832)