Identification Test for capsules: -
Boil one capsule shell with 25ml H
O, allow cooling & centrifuging. To 5ml of supernatantliquid add 1ml of tannic acid solution; a precipitate is produced in each case.
Microbial Limits: -
This test is done to check any presence of microbes, specially Bacteria in the capsule shell.
:- Crush the Capsule and
see the powder of shell under the microscope. Totalmicrobial count 1000g of capsule shells , 1.0g of capsules is free from E.Coli & Salmonella.
Loss on Drying: -
This test is done to check the moisture loosing limit of capsule sheel when kept in extremeconditions.
Between 12.5%& 16.0% determined on 1g of capsule shells by drying in anoven for 4 hrs or to constant weight.
Disintegration Test for Capsules: -
This test is provided to determine whether tablets or capsules disintegrate within theprescribed time when placed in a liquid medium under the experimental conditionspresented below.
For the purposes of this test, disintegration does not imply complete dissolution of the unit or even of its active constituent. Complete disintegration is defined as that state in which anyresidue of the unit, except fragments of insoluble coating or capsule shell, remaining on thescreen of the test apparatus or adhering to the lower surface of the discs, if used, is a softmass having no palpably firm core.
The apparatus consists of a basket-rack assembly, a 1 litre, low-form beaker,149 ± 11 mm in height and having an inside diameter of 106 ± 9 mm for the immersion fluid,a thermostatic arrangement for heating the fluid between 35 °C and 39 °C, and a device for raising and lowering the basket in the immersion fluid at a constant frequency rate between29 and 32 cycles per minute, through a distance of 55 ± 2 mm. The time required for theupward stroke is equal to the time required for the downward stroke, and the change instroke direction is a smooth transition, rather than an abrupt reversal of motion. The basket-rack assembly moves vertically along its axis. There is no appreciable horizontal motion or movement of the axis from the vertical. The assembly used is
The basket-rack assembly consists of 6 open-ended transparent tubes, each 77.5 ± 2.5 mm longand having an inside diameter of 21.85 ± 1.15 mm and a wall 1.9 ± 0.9 mm thick; the tubesare held in a vertical position by 2 plates, each 90 ± 2 mm in diameter and 6.75 ± 1.75 mm inthickness, with 6 holes, each 24 ± 2 mm in diameter, equidistant from the centre of the plateand equally spaced from one another.
Place 1 dosage unit in each of the 6 tubes of the basket and, if prescribed, add a disc. Operatethe apparatus using the specified medium, maintained at 37 ± 2 °C, as the immersion fluid.At the end of the specified time, lift the basket from the fluid and observe the dosage units:2