Pharmacopeial Requirements for Uncoated Tablets

Product : R&D No. : ..

Item
Definition #niformity of $eight

Specifications
Solid preparations each containing a single dose of one or more active substances and usually obtained by compressing uniform volumes of particles. %or ! tablets& not more than of the individual masses deviate from the average mass by more than the percentage deviation sho$n in 'able and none deviates by more than t$ice that percentage.See reference for more details 'ablets $ith a content of active substance less than mg or less than ( of the total mass must comply $ith uniformity of content test. %or ! tablets& the preparation fails to comply $ith the test if more than one individual content is outside the limits of )* ( to ++* ( of the average content. See reference for more details. %or tablets $eighing up to !.,* g each& ta-e a sample of ! tablets. for tablets $eighing more than !.,* g each& ta-e +! tablets. Rotate the drum +!! times& ma/imum loss of +( of the mass of the tablets tested is considered to be acceptable. See reference for more details 1arry out the measurement on +! tablets. 2ndicate type of apparatus and the orientation of tablets. 'he tablets comply $ith the test if all , tablets have disintegrated $ithin +* minutes. 2f the tablets fail to comply because of adherence to the discs& repeat the test on a further , tablets omitting the discs. See reference for more details 3 suitable test may be carried out to demonstrate the appropriate release of the active substance. Generally: %or , tablets& ta-e samples at "* minutes& the amount of active ingredient in solution is not less than 4!( of the prescribed or stated amount. See reference for more details 6a7 'otal viable aerobic count. Not more than +! 8 aerobic bacteria and not more than +! fungi per gram. 6b7 3bsence of 9scherichia coli per gram. See reference for more details

Reference

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#niformity of content

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%riability

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0ardness Disintegration

Dissolution

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5icrobial testing

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Reference : British Pharmacopoeia 2004.

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