Section 121A in The Drugs and Cosmetics Rules, 1945
121A. [ Test for pyrogens. [Added by Notification No. F.1.27/56-D, dated 18.12.1956 and amended by S.O. 1449, dated 13.6.1961.]
- Solution of substances intended for parenteral administration in large volumes (10 ml. or more at a time) shall be pyrogen-free and tested for pyrogens. If water or any other aqueous solvent is supplied alongwith the substances for preparing such solutions, it shall also be pyrogen-free and tested for pyrogens.]
