Appendix XII B. Monographs of the British Pharmacopoeia

The following additional points apply to monographs of the British Pharmacopoeia.

APPARATUS

The choice of the apparatus to be used depends on the physico-chemical characteristics of the dosage form. When this Appendix is invoked in an individual tablet or capsule monograph of the British Pharmacopoeia, use Apparatus I unless otherwise directed.

PROCEDURE

The dissolution medium is that specified in the individual monograph. Unless otherwise indicated in the monograph, withdraw samples at 45 minutes.

Where one tablet or capsule is directed to be placed in the apparatus, for each of the six tablets or capsules tested the amount of active ingredient in solution is not less than 70% of the prescribed or stated amount, unless otherwise specified in the monograph, except that if one fails this requirement a further six may be tested individually and all must comply. Where two or more tablets or capsules are directed to be placed together in the apparatus, a total of six replicate tests are carried out. In each test the amount of active ingredient in solution per tablet or capsule is not less than 70% of the prescribed or stated amount, unless otherwise specified in the monograph. No retesting is permitted.

Where capsule shells interfere with the analysis, remove the contents of no fewer than six capsules as completely as possible and dissolve the empty capsule shells in the specified volume of dissolution medium. Carry out the test as directed in the individual monograph and make any necessary correction. Correction factors should not be greater than 25% of the labelled content.