The contents of capsules other than Modified-release (Sustained-release) Capsules do not contain any added colouring agent. Hard Capsules: Hard capsul

fillers, wetting agents and disintegrating agents. The contents of capsules other than Modified-release (Sustained-release) Capsules do not contain any added colouring agent. Hard Capsules: Hard capsules contain the medicament(s) in the solid form. Where two mutually incompatible drugs are present in the mixture, one of the drugs can be put as a tablet or pellet or in small capsule and then enclosed with the other drug in a large capsule.Soft Capsules: Soft capsules shells are usually formed, filled with medicament and sealed in a combined operation on machines. In some cases, shells for extemporaneous use may be performed. The shells which are thicker than those of hard capsules are formed to produce capsules which are spherical, oval or 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 capsules 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 contents Less