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4.31 RESISTANCE TO CRUSHING OF TABLETS

      This test is intended to determine, under defined conditions, the resistance to crushing of tablets or hardness measured by the force needed to disrupt them by crushing.

Apparatus

      The apparatus consists of two jaws facing each other, one of which moves towards the other. The flat surfaces of the jaws are perpendicular to the direction of movement. The crushing surfaces of the jaws are flat and larger than the zone of contact with the tablet. The apparatus is calibrated using a system with a precision of 1 newton.

Procedure

      Place the tablet between the jaws, taking into account, where applicable, the shape, the break-mark and the inscription; for each measurement orient the tablet in the same way with respect to the direction of application of the force. Carry out the measurement on 10 tablets. Taking care that all fragments of the tablets have been removed before each determination.

      This procedure does not apply when fully automated equipment is used.

Expression of the Results

      Express the results as the mean, minimum and maximum values of the forces measured, all expressed in newtons.

      Indicate the type of apparatus and, where applicable, the orientation of the tablets.