cylindrical with hemispherical ends The shells may sometimes contain a medicament They may contain a preservative to prevent growth of fungi. The cont

cylindrical with hemispherical ends The shells may sometimes contain a medicament They may contain a preservative to prevent growth of fungi. The contents of soft capsules usually consist of liquids or solids dissolved or dispersed in suitable excipients to give a paste-like consistency but may also consist of powders or granules As soft gelatin shells contain appreciable amounts of water, migration of capsule contents, particularly of 'water-soluble ingredients, may occur Modified-release Capsules: Modified-release (Sustained-release) Capsules are hard or soft capsuls in which the contents or the shell, or both, contain auxiliary substances or are prepared by a special process designed to modify the rate at which the active ingredients are released Enteric Capsules: Enteric Capsules are hard or soft capsules prepared in such a manner that the shell resists the action of the gastric fluid but is attacked by the intestinal fluid to release the contents STANDARDSContent of active ingredients: Determine the amount of active ingredient(s) by the method desctibed 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%. For limits other than 90 to 110%, proportionately smaller or larger allowances should be made. Uniformity of weight: This test is not applicable to capsules that are required to comply with the test for Uniformity of content for all active ingredients. Weigh an intact capsule. Open the capsule without losing any part of the shell and remove the contents as completely as possible. To remove the contents of a soft capsule the shell may be washed with ether or other suitable solvent and the shell allowed to stand until the odour of the solvent is no longer detectable. Weigh the shell. The weight of the contents is the difference between the weighings Repeat the procedure with a further 19 capsules Determine the average weight. Not more than two of the individual weights deviate from the average weight by more than the percentage deviation shown in Table 2 and none deviates by more than twice that percentage TABLE 2Average weight of capsule Percentage deviation contentsLess than 300 mg 10300 mg or more 7.5 Uniformity of content: This test is applicable to capsules that contain' less than 10mg or less than 10% w/w of active ingredient. For capsules containing more than one active ingredient carry out the test for each active ingredient that corresponds to the afore-mentioned conditions. The test should be carried out only after the content of active ingredient(s) in a pooled sample of the capsules has been shown to be within accepted limits of the stated content NOTE - The test is not applicable for capsules containing multivitamins and trace elements. Determine the content of active ingredient in each of =10 capsules taken at random using the method given in the monograph or by any other suitable analytical method of equivalent accuracy and precision. The capsules comply with the test if not more