PROCESS FOR PREPARING PHARMACEUTICAL FORMULATION IN FORM OF ANTIOXIDANT-FREE SOLUTION FOR INJECTION CONTAINING PEMETREXED OR ITS SALT

摘要

The present invention provides a method for preparing a pharmaceutical formulation in the form of an antioxidant-free solution for injection, the method of which comprises: (a) controlling a dissolved oxygen concentration in a solution for injection comprising pemetrexed or its salt to 1 ppm or less; and (b) filling a container for injection with the solution obtained from the step (a), in a closed system having an oxygen partial pressure of 0.2 %v/v or less.