Transcription of 2.9.40. UNIFORMITY OF DOSAGE UNITS - …
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2.9.40. UNIFORMITY OF DOSAGE UNITS - …
EUROPEAN PHARMACOPOEIA UNIFORMITY of DOSAGE unitsFigure Funnel(dimensions in millimetres)Figure Guide (section G-G)(dimensions in millimetres)The gum is artificially chewed by the horizontal pistons, andthe vertical piston ensures that the gum stays in the rightplace between speed is controlled to ensure a constant cycle. Onecycle (chew) is defined as follows: the horizontal pistonsstart from their outermost position, move to their innermostposition and back to their outermost position. Within onecycle, the vertical piston moves from its lowest position to itsuppermost position and back to its lowest horizontal piston has a stroke of mm. Themaximum distance between these 2 pistons is 50 minimum distance between the 2 horizontal pistonsis mm to mm. The vertical piston has a stroke piston movement is controlled, so that the2 pistons are at their innermost position at the same piston movement is controlled, so it does not conflictwith the movement of the horizontal necessary, the machine can be constructed so that thehorizontal pistons rotate around their own axes in oppositedirection to each other by the end of the chew in order toobtain maximum parts of the apparatus that may come in contact with thepreparation or the dissolution medium are chemically inertand do not adsorb, react or interfere with the each determination, the following information is needed: composition, volume and temperature of the dissolutionmedium, numberofchewsper
2.9.40. Uniformity of dosage units EUROPEAN PHARMACOPOEIA 5.2 to determine whether the individual contents are within the limits set. The content uniformity method may be applied in
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