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<88> BIOLOGICAL REACTIVITY TESTS, IN VIVO - DrugFuture

94 87 BIOLOGICAL REACTIVITY Tests, In Vitro / BIOLOGICAL TestsUSP 35(mildly reactive). Repeat the procedure if the suitability oflogical REACTIVITY Tests, In Vitro 87 have indicated significantthe system is not confirmed. For dose-response evaluations, BIOLOGICAL REACTIVITY . These two tests are used for plasticsrepeat the procedure, using quantitative dilutions of theand other polymers in addition to a third test, the Implanta-sample Test, to test the suitability of these materials intendedfor use in fabricating containers and accessories thereto, foruse in parenteral preparations, and for use in medical de-Table 2.

Extract of Sample in Sodium Chlo-0.2 mL/animal at each x x x x x x ride Injection Rabbit of 10 sites B x x x x x Extract of Sample in 1 in 20 Solu-Mouse 50 mL/kg A (iv) tion of Alcohol in Sodium Chloride 0.2 mL/animal at each x x x x x Injection Rabbit of 10 sites B x x x Mouse 10 g/kg A (ip) Extract of Sample in Polyethylene 0.2 mL/animal at each

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