Question:
A suitable substance or mixture of substances to prevent the growth of microorganisms must be added to preparations intended for injection that are packaged in multiple dose containers, regardless of the method of sterilization employed Unless one of the following conditions prevails:
Author: LEIGHTON DWIGHT OBILLOSAnswer:
(1) there are different directions in the individual monograph; (2) the substance contains a radionuclide with a physical halflife of less than 24 hours; and (3) the active ingredients are themselves antimicrobial.
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