§ 436.217 - Film-coat rupture test.

(a) Immersion fluid. Dilute 6.0 milliliters of hydrochloric acid to 1,000 milliliters with water. During the performance of the test maintain the immersion fluid at a temperature of 37±0.5 °C by using a thermostatically controlled water bath.

(b) Immersion vessel. Use a suitable vessel, such as a 1-liter beaker.

(c) Operation. Add 750 milliliters of immersion fluid to the immersion vessel.

(d) Procedure. Drop a tablet into the immersion fluid and record the time for the tablet coat to rupture. Repeat the test with a further 19 tablets, testing not more than 10 tablets with a given volume of immersion fluid.

(e) Evaluation. The tablets pass the film-coat rupture test if the mean coat rupture time does not exceed 20 seconds and not more than 2 tablets have a coat rupture time exceeding 40 seconds.