§ 331.24 - Tablet disintegration test.

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A tablet disintegration test shall be performed on tablets that are not to be chewed following the procedures described in the United States Pharmacopeia XVIII (page 932). If the label states the tablet may be swallowed, it must disintegrate within a 10-minute time limit pursuant to the test procedure using simulated gastric fluid test solution without enzymes, the United States Pharmacopeia XVIII page 1026, rather than water as the immersion fluid.

                    
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