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This guidance will not be meant to outline registration and/or filing needs or modify pharmacopoeial necessities. This guidance does not affect the ability of your dependable regulatory agency to establish certain registration/submitting prerequisites regarding APIs within the context of marketing/manufacturing authorizations or drug programs. All

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Suspend the assembly throughout the beaker containing the specified liquid, operate the equipment for the specified time, and get away the assembly from the liquid. The tablets and capsules pass the test if all of these have completely disintegrated.b. A motor having a pace regulator effective at sustaining the velocity of rotation with the paddle

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